Priothera Receives Fast Track Designation for mocravimod in Combination with Allogeneic Hematopoietic Stem Cell Transplant (HSCT) for Post Remission Therapy of Acute Myeloid Leukemia (AML) Patients

Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for mocravimod in combination with allogeneic Hematopoietic Stem Cell Transplant (HSCT) for post remission therapy of Acute Myeloid Leukemia (AML) patients. FDA’s Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.

Priothera is working to initiate the MO-TRANS global Phase 2b/3 study in Europe, US and Japan, to assess the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult AML patients undergoing allogeneic HSCT. The MO-TRANS study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.

Karen Von Graevenitz, Head of Regulatory Affairs at Priothera, commented: “The Fast Track designation grant for mocravimod in combination with allogeneic HSCT is an important milestone and underlines the significant unmet need in AML patients undergoing HSCT, a serious disease where currently no available therapy exists. The designation means mocravimod will be eligible for expedited review and we will work closely with the US FDA to advance the global Phase 2/3 trial which is due to start in the second half of 2022.”

Florent Gros, Co-Founder and CEO of Priothera, added: “Following being granted orphan drug designations for mocravimod in the US and Europe, we are pleased to have been granted Fast Track designation for this highly promising compound. This important regulatory milestone moves us a step closer to bringing mocravimod to patients with AML and other hematologic malignancies.”

About mocravimod

Mocravimod (also known as KRP203), is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers.

Mocravimod will be investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogeneic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages S1PR modulator’s unique mode of action to maintain anti-leukemia activity - graft-versus leukemia (GVL) while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogeneic HSCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.

About Priothera

Priothera is leading the way in developing orally applied sphingosine-1-phosphate (S1P) receptor modulators for the treatment of hematological malignancies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues. Not being an immunosuppressant, mocravimod maintains the graft-versus-leukemia (GVL) benefits in patients receiving HSCT while inhibiting graft-versus-host-disease (GVHD).

Priothera was founded in 2020 by an experienced team of drug development experts and is headquartered in Dublin, Ireland, and with a subsidiary in Saint-Louis, France. The Company is backed by international founding investors Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden) and EarlyBird Venture Capital (Berlin, Germany).

For more information please visit: www.priothera.com or follow Priothera on LinkedIn www.linkedin.com/company/priothera/

Contacts

Priothera
Florent Gros, CEO
E: info@priothera.com

MEDiSTRAVA Consulting
Sylvie Berrebi, Sandi Greenwood, Frazer Hall
E: priothera@medistrava.com
T: +44 (0) 203 928 6900

Inotrem announce the appointment of Luke Beshar as Chairman of Board of Directors

Inotrem, an advanced clinical stage biotech company developing TREM- 1 targeting immunotherapies for acute and chronic inflammatory syndromes, announced today the appointment of Luke Beshar as Chairman of its Board of Directors, effective May 25, 2022. Mr. Beshar succeeds Thierry Hercend who served as Chairman since 2014 and remains a member of the Board of Directors.

“We are pleased to welcome Luke Beshar to the Inotrem Board. Luke's deep experience in strategic development of biotech companies, in both executive and Board level positions of several public and private life science companies will be invaluable to Inotrem as we grow our business and pursue our mission to bring new treatments to patients suffering from inflammatory conditions” said Sven Zimmermann, Chief Executive Officer of Inotrem. “On behalf of the entire Inotrem team, I would like to thank Thierry Hercend for the exceptional work he has accomplished over the years as our Chairman and look very much forward to continue working with him as an Independent Non-executive Board member.”

“I feel privileged to take on this role at such an exciting time for Inotrem,” said Luke Beshar. “I am impressed by the quality of the pioneering work the team has accomplished on the biology of TREM-1 and its clinical translation in severe conditions such as septic shock and severe COVID-19. I’m also really excited about the anti-TREM1 pre-clinical monoclonal antibody programs in chronic inflammation and immuno-oncology. I look forward to working with Sven and the team on Inotrem’s accelerating growth and next stage of development.”

Luke Beshar is a seasoned biotechnology executive and financial expert with more than 35 years of general and financial management experience at various public and private companies. Mr. Beshar currently serves as Chairman of the Board of Protara Therapeutics, Inc., a publicly held company focused on immuno-oncology. Mr. Beshar also serves as director and chair of the audit committee of Omega Therapeutics and previously served as a director at Trillium Therapeutics Inc., a publicly held immuno-oncology company, from 2014 until it was acquired by Pfizer in November 2021 and was chair of its audit and compensation committees. Mr. Beshar previously served as a director and chair of audit committee of REGENXBIO Inc. from 2015 (pre-IPO) to 2021. Prior to this, Mr. Beshar served as Executive Vice President and Chief Financial Officer of NPS Pharmaceuticals, Inc. from November 2007 until it was sold to Takeda (Shire plc) in February 2015 and Executive Vice President and Chief Financial Officer of Cambrex Corporation, from 2002 to 2007. Mr. Beshar holds a B.S. degree in Accounting and Finance from Michigan State University and is a Certified Public Accountant.

About Inotrem

Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, LR12 (nangibotide), with potential applications in a number of therapeutic indications such as septic shock and myocardial infarction. In parallel, Inotrem has also launched another program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr Marc Derive. Inotrem is supported by leading European and North American investors. www.inotrem.com

Medical Microinstruments Launches New Simulator for Robotic Microsurgery

Symani Simulator to accelerate the expansion and adoption of robotic microsurgery

Medical Microinstruments (MMI) SpA, a robotics company dedicated to improving clinical outcomes for patients undergoing microsurgery, today announced the launch of its Symani Surgical System Simulator developed by VirtaMed. The simulator will improve, expand, and digitize the pathways for Symani training as surgeons prepare to expand their microsurgical skills through robotics.

“It was a priority for our company to offer our surgeons a simulation solution so they can practice robotic microsurgery in a more convenient way,” said Mark Toland, CEO of MMI SpA. “By training on the simulator, surgeons will be even more prepared for their first Symani patient or for a challenging case.”

“We were looking for a way to provide surgeons with a Symani experience without needing to transport the system,” said Jamie Milas, VP of Marketing at MMI SpA. “We selected VirtaMed as our trusted partner because of their shared passion for improving patient care and because we knew that they could develop a fully customized simulator that would emulate our device and showcase the advantages of Symani microsurgery.”

VirtaMed was incorporated in 2007 and is a world leader in surgical training solutions and data-driven medical education. VirtaMed develops world-class and educationally relevant virtual reality simulators for various medical disciplines such as orthopedics, obstetrics, gynecology, urology and laparoscopy. The VirtaMed LaparoSTM offers an experience that looks and feels real to the users, including correct physical behavior of internal organs and true to life interactions of surgical tools with those organs.

“We’re thrilled to partner with MMI to address this new frontier of robotic surgery,” said Stefan Tuchschmid, Co- CEO at VirtaMed. “MMI’s technology provides tremendous value for the surgical community and the patients they serve. We’re proud that our collaboration has led to a simulator that’s so realistic that surgeons can immediately begin suturing on Symani after just a few minutes of practice on the simulator.”

Incorporating simulation will also accelerate MMI’s product development process by enabling new solutions to be tested in a virtual environment for efficacy and usability.

MMI’s Symani Surgical System is the only robot dedicated to microsurgery that offers wristed instruments designed to improve a surgeon’s ability to access and suture small, delicate anatomy. Its platform provides motion scaling and tremor reduction to allow surgeons to make precise micro-movements. With Symani, surgeons can perform suturing, ligation, anastomoses and coaptations.

MMI will exhibit at the European Association of Plastic Surgeons, May 26-28 in Naples, Italy and at the World Society for Reconstructive Microsurgery Congress, June 1-4, in Cancun, Mexico. Demonstrations of the Symani Simulator and Symani Surgical System will be available at the MMI booth.

About MMI SpA

Medical Microinstruments S.p.A. (MMI) was founded in 2015 near Pisa, Italy to enhance surgical performance through the development of a robotic system that enables surgeons to achieve better outcomes in microsurgery. The Symani Surgical System combines proprietary innovations including the world’s smallest wristed microinstruments as well as tremor-reducing and motion-scaling technologies. Together, these powerful capabilities allow more surgeons to successfully perform microsurgery while expanding the field of supermicrosurgery. MMI is backed by international medtech investors including Andera Partners, Panakes Partners, Fountain Healthcare Partners and Sambatech.

About VirtaMed

VirtaMed believes medical education is powerfully delivered through data-driven simulation solutions. Since 2007, we have developed the leading solutions for training outside the operating room because we believe healthcare professionals should never have to perform a procedure for the first time on a patient. VirtaMed’s simulators provide the most realistic and cost-effective training available for laparoscopic surgeons.

Media Contact:

Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com

Media Contact VirtaMed:

Alex Gunderson
Padilla
Alex.Gunderson@padillaco.com

Medical Microinstruments Announces Major Expansion in Pisa, Italy to Support Growth

New facility will expedite the development and production of MMI’s Symani® robotic microsurgical system

Medical Microinstruments (MMI) SpA, a robotics company dedicated to improving clinical outcomes for patients undergoing microsurgery, today announced the grand opening of its new facility in Pisa, Italy. MMI consolidated locations throughout the Pisa area into a 3,000m2 singular site designed to accommodate company growth. The state-of-the-art facility will serve as the global ‘Center of Excellence’ for microsurgical surgical robotics, encompassing development, manufacturing, and administration.

“Our new facility in Pisa marks the beginning of an exciting new era for MMI,” said Mark Toland, CEO of MMI. “This new space reflects our focus on innovation, collaboration and growth. The expanded manufacturing center will ensure that we are prepared to address new markets and reach more patients with our Symani System and NanoWrist® Instruments.”

The building was fully renovated over 12 months and will serve as the primary office for employees, including a large team of R&D professionals with access to five new advanced R&D labs.

“Working all together in the new facility improves communication and disruptive innovation which is ideal for our research, engineering and clinical efforts,” said Massimiliano Simi, VP of R&D at MMI. “With our new laboratories, we are poised to continue the rapid development and high-quality product design our surgeon’s have come to expect.”

The space was designed to promote teamwork and accommodate the company’s fast growth with 40 additional hires expected by the end of 2022. The 900m2 state-of-the-art manufacturing center includes a clean room and with the capacity to meet the global demand for at least the next 5 years.

“Our cutting-edge facility touts the most advanced manufacturing technologies and production processes, many of which we have patented,” commented Giancarlo Testaverde, VP of Operations at MMI. “We are equipped and ready to meet the increased demands as we expand our installed base and address new markets.”

The Symani System is the only robotic surgical system that offers wristed microinstruments designed to improve a surgeon’s ability to access and suture small, delicate anatomy. The platform provides motion scaling and tremor reduction to allow surgeons to perform precise micro-movements. With Symani, surgeons can perform suturing, anastomoses and coaptations which are required during many complex microsurgical procedures.

"I'm pleased to welcome MMI, an innovative company that fully embodies the entrepreneurial spirit of Tuscany, to its new office in Pisa," said Eugenio Giani, President of Tuscany. "The life sciences industry is growing in our region, and we're eager to support the future growth of the company, especially through our ‘Invest In Tuscany’ office."

About MMI SpA

Medical Microinstruments S.p.A. (MMI) was founded in 2015 near Pisa, Italy to enhance surgical performance through the development of a robotic system that enables surgeons to achieve better outcomes in microsurgery. The Symani Surgical System combines proprietary innovations including the world’s smallest wristed microinstruments as well as tremor-reducing and motion-scaling technologies. Together, these powerful capabilities allow more surgeons to successfully perform microsurgery while expanding the field of supermicrosurgery. MMI is backed by international medtech investors including Andera Partners, Panakes Partners, Fountain Healthcare Partners and Sambatech.

Media Contact:
Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com

XyloCor Therapeutics Announces Presentation of Preliminary Clinical Data from Phase 1 Portion of the EXACT Phase 1/2 Study of XC001 Novel Gene Therapy for Refractory Angina at AATS and ASGCT

• Data from the Phase 1 dose‑escalation portion of the Phase 1/2 EXACT study demonstrate XC001 was well‑tolerated at all dose levels tested; highest dose level evaluated selected for ongoing Phase 2 portion of the study

• Preliminary efficacy data highlight XC001 potential for patients with refractory angina with no other treatment options

• Treatment strategy is to use local administration to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects

• Completion of Phase 2 enrollment is expected by the end of May 2022

XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced presentation of initial clinical data from the Phase 1 portion of its ongoing Phase 1/2 clinical trial (EXACT) for refractory angina at the American Association for Thoracic Surgery (AATS) Annual Meeting on May 15, 2022, and at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting on May 18, 2022.

XC001: Locally administered, single‑dose gene therapy candidate to address the unmet need in refractory angina

XyloCor’s lead investigational drug, XC001 (encoberminogene rezmadenovec), is under development as a novel approach to treating patients with refractory angina who have exhausted other medical and surgical options. This investigational gene therapy is designed to activate naturally occurring biological pathways by creating new vessels to improve blood flow to areas of the heart not receiving adequate blood supply. This restored blood supply could potentially improve patients’ quality of life by enabling them to resume physical activities and it could reduce episodes of chest pain associated with refractory angina.

In the Phase 1 portion of the EXACT study, 12 subjects with Canadian Cardiovascular Society (CCS) angina class 2‑4 without revascularization options were divided into four escalating dose groups with three subjects each. Each subject received 15 epicardial injections of XC001 at one of the four dosage levels. Safety, efficacy and tolerability evaluations were measured as adverse events (AEs), serious adverse events (SAEs) and change from baseline from three to six months post‑treatment in exercise capacity, ischemic burden by positron emission tomography (PET) imaging, and patient‑reported symptomatology.

No drug‑related SAEs, bleeding complications or ventricular arrhythmias were observed in this Phase 1 dose‑escalation study. Over a six‑month follow up there were a total of 17 SAEs in seven subjects. Eleven SAEs were related to the underlying disease process or other causes. The other six SAEs which occurred in four subjects were judged to be related to the administration procedure, with none of those being unexpected nor resulting in patient death.

“The administration of XC001 appears to have been well‑tolerated at all tested doses,” said Nahush Mokadam, M.D., presenting author at AATS, Division Director, Cardiac Surgery, The Ohio State University Wexner Medical Center and Associate Director of the Heart and Vascular Center and site Principal Investigator for this study. “Objective criteria, including results from exercise tolerance tests and PET scans, suggest therapeutic potential.”

Although the Phase 1 portion of the study was primarily focused on safety and Phase 2 dose selection, initial clinical efficacy data appeared promising. Notably, the data showed positive trends in total exercise duration and reductions in patient symptoms and ischemic burden. Although patient numbers are small, preliminary data suggest that response may be correlated to administered dose.

“The preliminary efficacy evaluation suggests a dose response which is encouraging for the development of XC001 as a therapeutic strategy,” said Thomas Povsic, M.D., Ph.D., Professor of Medicine, Duke University School of Medicine and National Principal Investigator for the EXACT study. “We anticipate that the Phase 2 expansion portion of this study, which is testing the highest and most efficacious dose from Phase I, will complete enrollment this month. We are incredibly excited by the potential for this investigational therapy to improve the quality of life for these cardiac patients.”

“In many other gene therapy trials, safety concerns arose due to systemic administration of high viral particle loads,” added Dr. Povsic. “In contrast, because we can inject XC001 directly into the heart, we can dramatically reduce overall viral particle loads and systemic exposure while increasing efficacy.”

EXACT Phase 1/2 Study Data Presentations at AATS and ASGCT

Lead author, Dr. Mokadam presented three‑month data from the Phase 1 study in the presentation, Dose Escalation Study of Encoberminogene Rezmadenovec (Adenoviral Vector with Multiple Isoforms of Vascular Endothelial Growth Factor) in Refractory Angina: Phase 1 Results at the AATS Annual Meeting.

Dr. Povsic will present six‑month data from the Phase 1 study in the presentation, Preliminary Safety, Tolerability and Efficacy of Direct Epicardial Administration of Encoberminogene Rezmadenovec to Ischemic Myocardium in Patients with Refractory Angina: Six Month Phase 1 Data at the ASGCT 25th Annual Meeting.

About the EXACT Study

The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open‑label, single‑arm trial. Twelve subjects (n=3 per dose cohort) who have refractory angina were enrolled into four ascending dose groups, to be followed by an expansion phase of the trial with 27 additional subjects at the highest tolerated dose. The trial is designed to assess the preliminary safety and efficacy of XC001. The investigational gene therapy is administered directly to the heart muscle through a mini‑thoracotomy by an experienced cardiac surgeon. The EXACT trial is being conducted at top cardiovascular research sites across the United States.

About Chronic Refractory Angina

In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients’ chest pain. An estimated one million people suffer from refractory angina in the United States.

About XyloCor

XyloCor Therapeutics is a private, clinical‑stage biopharmaceutical company developing potential best‑in‑class gene therapies to transform outcomes for patients with cardiovascular disease. The Company’s lead product candidate, XC001, is in clinical development to investigate use for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, M.D., and Todd Rosengart, M.D., has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Media Contact

Mike Beyer
Sam Brown Inc. Healthcare Communications
mikebeyer@sambrown.com
312-961-2502

Vivasure Medical Announces Series D Financing to Advance Portfolio of PerQseal Vessel Closure Devices

Funds will support clinical development and regulatory approval of fully absorbable percutaneous closure devices for large-bore vessels

Vivasure Medical® (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced the closing of the first tranche of €22 million ($23M) as part of its Series D financing round that could reach up to €52 million ($54M) in total. Led by a multi-national strategic corporation, the financing includes an option to buy the Company upon certain milestones. Other participants in this Series D financing round include a second strategic corporate investor as well as existing investors, Fountain Healthcare Partners, Orchestra BioMed, LSP Health Economics Fund managed by the EQT Life Sciences team, Panakès Partners and Evonik Venture Capital.

The financing will support the U.S. and European clinical development and regulatory approval of the Company’s portfolio of fully absorbable, patch-based large-bore percutaneous vessel closure devices for transcatheter endovascular and cardiovascular procedures, including PerQseal® and PerQseal+ for arterial closure and PerQseal Blue for venous closure. Vivasure’s innovative PerQseal technology consists of a proprietary bioabsorbable intravascular patch that seals the vessel from the inside, returning the artery or vein to its natural state without leaving behind the remains of any materials such as collagen, metal implants or sutures commonly used in other closure technologies.

Vivasure Medical’s PerQseal device is the first sutureless and fully absorbable synthetic implant for large-bore arterial vessel punctures and is available to physicians in Europe for use in transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR) and endovascular abdominal aneurysm repair (EVAR). The Company’s next-generation PerQseal+ device has an enhanced bioabsorbable patch designed to address more complex patient anatomies and is currently under clinical evaluation in Europe and the U.S. Vivasure is also developing PerQseal Blue, designed exclusively for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, such as transcatheter mitral valve repair or replacement (TMVR), transcatheter tricuspid valve repair or replacement (TTVR) and leadless pacemaker implants. Currently, there are no sutureless options available for vessel closure following large-bore venous procedures.

“As minimally invasive approaches have become the standard of care for cardiovascular procedures, conventional vessel closure techniques have proven to prolong recovery and lead to bleeding complications for patients. This funding represents an important milestone for our company that will help to further advance our portfolio of novel PerQseal sutureless and fully absorbable vessel closure devices in the U.S. and Europe,” said Andrew Glass, chief executive officer of Vivasure Medical. “We are encouraged by early clinical progress from leading heart centers participating in studies currently underway for PerQseal+ and PerQseal Blue, and we look forward to initiating a U.S. pivotal study for PerQseal+ later this year that will support our submission to the FDA.”

“While tremendous progress has been made for minimally invasive structural heart procedures, vascular issues related to the closure of the procedure remain the most common complication of these interventions,” said Azeem Latib, M.D., section head and director of interventional cardiology and director of structural heart interventions at Montefiore Health System. “The novel PerQseal technology is designed to address these shortcomings and has tremendous potential to improve patient outcomes and enhance procedure efficiency.”

About Vivasure Medical

Based in Galway, Ireland, Vivasure is a medical device company developing advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility and is backed by leading international medtech investors. For more information, please visit www.vivasuremedical.com.

PerQseal®, PerQseal®+ and PerQseal® Blue are not available for sale in the United States.

Contacts

Sierra Smith
408-540-4296
sierra@healthandcommerce.com

Priothera Receives FDA clearance of IND to start Phase 2b/3 study with mocravimod in Acute Myeloid Leukemia (AML) Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

Global Phase 2b/3 trial (MO-TRANS) assessing the efficacy and safety of mocravimod, a novel S1P receptor modulator, as an adjunctive and maintenance therapy in AML patients undergoing allogeneic HSCT, planned to start in H2 2022

Priothera Ltd, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, today announces that the U.S. Food and Drug Administration (FDA) has provided clearance to proceed with the Company's Investigational New Drug (IND) application to begin its pivotal Phase 2b/3 study of mocravimod (named MO-TRANS).

Priothera will initiate the MO-TRANS global Phase 2b/3 study in Europe, US and Japan, assessing the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult Acute Myeloid Leukemia (AML) patients undergoing allogenic hematopoietic stem cell transplant (HSCT). The MO-TRANS study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.

Allogenic stem cell transplantation is the only potentially curative approach for AML patients, however current treatment options are still associated with a high number of side effects, and high mortality rates.

Florent Gros, Co-Founder and CEO of Priothera, commented "The FDA IND clearance to initiate the MO-TRANS study assessing mocravimod in AML patients undergoing allogeneic HSCT is another major milestone for Priothera. We are on track to initiate this pivotal Phase 2b/3 clinical trial and are looking forward to working alongside a large team of enthusiastic investigators across the US, Europe and Asia, who share our goal of bringing mocravimod to patients as an adjunctive and maintenance treatment for AML and potentially other hematologic malignancies."

About mocravimod

Mocravimod (also known as KRP203), is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers.

Mocravimod will be investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogenic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages S1PR modulator's unique mode of action to maintain anti-leukemia activity - graft-versus leukemia (GVL) while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogenic HSCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.

About Priothera

Priothera is leading the way in developing orally applied sphingosine-1-phosphate (S1P) receptor modulators for the treatment of hematological malignancies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues. Not being an immunosuppressant, mocravimod maintains the graft-versus-leukemia (GVL) benefits in patients receiving HSCT while inhibiting graft-versus-host-disease (GvHD).

Priothera was founded in 2020 by an experienced team of drug development experts and is headquartered in Dublin, Ireland, and with a subsidiary in Saint-Louis, France. The Company is backed by international founding investors Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden) and EarlyBird Venture Capital (Berlin, Germany).

For more information please visit: www.priothera.com

Contacts

Priothera
Florent Gros, CEO
E: info@priothera.com

MEDiSTRAVA Consulting
Sylvie Berrebi, Sandi Greenwood, Frazer Hall
E: priothera@medistrava.com
T: +44 (0) 203 928 6900

Vivasure Medical Begins Clinical Evaluation of Next-Generation PerQseal+ Device

Vivasure Medical® today announced the first patient was enrolled in the Frontier V study, a European multicenter study evaluating PerQseal®+, the next generation of the company’s PerQseal® device. The patient was enrolled by Dr. Fernando Gatto, head of cardiac catheter labs and senior interventional cardiologist at SHG-Kliniken Völklingen in Völklingen, Germany and investigator of the study. The study will evaluate the company’s next-generation PerQseal+ device with an enhanced bioabsorbable patch designed to address more complex patient anatomies.

The company’s PerQseal device is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. PerQseal is currently available to physicians in Europe for use in novel transcatheter endovascular procedures, including transcatheter aortic valve replacement (TAVR), thoracic endovascular aneurysm repair (TEVAR), and endovascular abdominal aneurysm repair (EVAR), that require large-bore vessel access. The enhanced PerQseal+ device is intended to provide physicians with an even more robust solution for managing challenges and bleeding complications associated with large-bore closure.

“PerQseal+ is a promising potential advancement for providing simple and sutureless closure for large-bore vascular procedures,” said Dr. Gatto. “Rapid and secure vessel closure has remained a high priority for interventional cardiologists as more and more structural heart procedures transition to fully percutaneous approaches. Vascular complications remain a significant challenge for TAVR, and these complications are associated with more adverse events and increased costs. I am honored to participate in this study because PerQseal+ may help elevate the standard of care for our patients.”

“The current generation of the PerQseal device has proven to be a reliable and valuable addition to our tool chest for large bore closure,” said Dr. Christian Frerker, head of structural heart disease and senior cardiologist at the University of Schleswig-Holstein in Lübeck, Germany, and principal investigator of the Frontier V study. “This study will provide us with a better understanding of PerQseal+’s potential benefits in our growing complex patient population.”

“Enrolling the first patient in the Frontier V study is an exciting milestone in Vivasure’s mission to ensure success for percutaneous cardiovascular therapies,” said Andrew Glass, CEO of Vivasure. “The original PerQseal device has been well-received by clinicians since it became available in Europe because it helps address the complications and risks associated with access-site management for large-bore procedures. The enhanced PerQseal+ device promises to build on that success by enabling even better patient outcomes.”

Inotrem and the Crohn’s & Colitis Foundation Sign a R&D Collaboration Agreement to Support the Development of a New Therapeutic Approach in Inflammatory Bowel Disease (IBD)

Inotrem will leverage cohort resources from the Foundation to identify a new therapeutic target focusing on the TREM-1 pathway.

Inotrem, an advanced clinical stage biotech company specialized in immunotherapies for acute and chronic inflammatory syndromes, announced today a R&D collaboration agreement with the Crohn’s & Colitis Foundation to support the development of a new therapeutic approach in IBD. The Crohn’s & Colitis Foundation is one of world’s largest and most influential non-profit organization dedicated to finding cures for Crohn’s disease and ulcerative colitis.

The objective of the R&D collaboration is to confirm the relationship between the activation of the TREM-1 pathway and the severity and progression of IBD in patients, with the ultimate intention of developing a new treatment. Inotrem will conduct this project in partnership with the Division of Gastroenterology at the Icahn School of Medicine at Mount Sinai in New York. Under the terms of the agreement, Inotrem will access data and bio-samples from Foundation’s IBD Plexus®, which is the largest IBD database in the US with data from over 25,000 patients. The project is expected to last 18 months and will be a cornerstone in the design of Inotrem’s new drug candidate first-in-human clinical study.

There are today 10 million people worldwide suffering from IBD (Crohn’s disease and ulcerative colitis), a lifelong illness for which the medical need continues to be important despite improvement over the last 30 years. Approximately 30% of patients are primarily unresponsive to existing therapies and even among responders, up to 10% will lose their response to the drug every year.

For a decade, Inotrem has been pioneering the biology of TREM-1 as a regulator of the immune response in acute and chronic inflammatory diseases. TREM-1 has been reported as a likely contributor to IBD pathophysiology, and targeting this biological pathway could offer a new treatment option for IBD patients with immune dysregulation.

Sven Zimmermann, CEO of Inotrem, says: "We are looking forward to collaborating with such a recognized and well-respected organization as The Crohn’s & Colitis Foundation. The robustness and diversity of their IBD patient database is unparalleled and will allow for in-depth analysis of TREM-1 potential as a therapeutic target in IBD patients. This agreement marks the beginning a long and fruitful partnership".

"We are dedicated to finding cures for Crohn’s disease and ulcerative colitis and improving the quality of life for those affected by these diseases," said Dr. Caren Heller, Chief Scientific Officer for the Crohn’s & Colitis Foundation. "We are pleased to work with Inotrem, a company that has developed a strong scientific leadership around the TREM-1 pathway, and look forward to understanding the potential ways that the TREM-1 pathway may play a role in the treatment of inflammatory bowel disease."

About Inotrem

Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, LR12 (nangibotide), with potential applications in a number of therapeutic indications such as septic shock and myocardial infarction. In parallel, Inotrem has also launched another program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr Marc Derive. Inotrem is supported by leading European and North American investors. www.inotrem.com

Contacts

Media contact for Inotrem

Anne REIN
Strategies & Image (S&I)
anne.rein@strategiesimage.com
+33 6 03 35 92 05

Priothera Receives First Regulatory Approvals to Start a Global Pivotal Study with Mocravimod in Acute Myeloid Leukemia Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant

Global Phase 2b/3 trial assessing the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in AML patients undergoing allogeneic HSCT planned to start in H2 2022

Priothera Ltd, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator mocravimod, today announces it has received the two first European country approvals from the Swiss and French national health authorities (Swissmedic and ANSM) to begin its planned pivotal study of mocravimod. The company has also received encouraging feedback from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on the clinical study design that is closely aligned with earlier feedback from the US Food and Drug Administration (FDA).

Priothera will initiate a global Phase 2b/3 study (MO-TRANS study) in Europe, US and Japan, assessing the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult Acute Myeloid Leukemia (AML) patients undergoing allogenic hematopoietic stem cell transplant (HSCT). The MO-TRANS study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.

Florent Gros, Co-Founder and CEO of Priothera, commented “Following on from our recent receipt of orphan drug designations for mocravimod in the US and Europe, we are pleased to have received our first approvals to initiate this key global Phase 2b/3 trial with this highly promising compound. Moreover, the CHMP feedback is encouraging, and is also closely aligned with the feedback we received from the FDA. These first approvals are important regulatory and clinical milestones for Priothera and move us a step closer to bringing mocravimod, an adjunctive and maintenance treatment, to patients with AML and other hematologic malignancies, for whom there remains a significant unmet medical need.”

About mocravimod

Mocravimod (also known as KRP203), is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers.

Mocravimod will be investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogenic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages S1PR modulator’s unique mode of action to maintain anti-leukemia activity – graft-versus leukemia (GVL) while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogenic HSCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.

About Priothera

Priothera is leading the way in developing orally applied sphingosine 1 phosphate (S1P) receptor modulators for the treatment of hematological malignancies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues. Not being an immunosuppressant, mocravimod maintains the graft-versus-leukemia (GVL) benefits in patients receiving HSCT while inhibiting graft-versus-host-disease (GvHD).

Priothera was founded in 2020 by an experienced team of drug development experts and is headquartered in Dublin, Ireland, and with a subsidiary in Saint-Louis, France. The Company is backed by international founding investors Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden) and EarlyBird Venture Capital (Berlin, Germany).

For more information please visit: www.priothera.com

Neuromod establishes global commercial leadership team

• Cross-functional team will further support key clinical partners providing Lenire®

• Eric Timm appointed President, Global Commercial Operations

• Florian Elsaesser appointed Chief Strategy and Corporate Development Officer

Neuromod Devices Ltd. has announced the formation of a global commercial leadership team to direct the commercialisation of its Lenire tinnitus treatment device through key partnerships.

The establishment of the team sees the organisation’s U.S. leadership executives Tish Ramirez, Holly Dean, and Stephanie Glowacki join its existing commercial leadership to establish a cross-functional group with significant sales, marketing, finance, and clinical experience in the hearing healthcare industry. The cross-functional team’s strategy will support existing clinical partners to continue achieving successful treatment outcomes through further clinical and commercial initiatives while partnering with key specialist clinicians to introduce Lenire in new markets.

In addition to his role as CEO of Neuromod USA Inc., Neuromod’s wholly owned U.S. subsidiary, Eric Timm has been appointed President, Global Commercial Operations to head the newly formed team with global responsibility for the organisation’s commercial strategy.

“Since bringing Lenire to market we’ve achieved significant success by expanding its availability across Europe. Building on that success I am delighted to announce the formation of our global commercial leadership team to further support our healthcare partners in achieving positive outcomes for their tinnitus patients and introduce Lenire to new markets through key partnerships”, says Ross O’Neill, Founder and CEO, Neuromod Devices Ltd.

Mr. Timm has more than 35 years’ experience holding leadership positions in medical devices and hearing aid companies. He joined Neuromod as CEO of Neuromod USA in 2021 from WS Audiology, one of the biggest hearing aid manufacturers in the world, where he was President and Chief Executive Officer of the company’s U.S. wholesale business.

Before that, he was CEO of Sivantos USA when it merged with Widex to become WS Audiology. He had previously been Chief Operating Officer of Sivantos USA. In addition, Eric has held general management, sales, marketing, and corporate strategy leadership positions at Phonak, Cardinal Health, Bristol-Myers Squibb and 3M.

“Since joining Neuromod I have seen first-hand the tremendous outcomes tinnitus patients have achieved using Lenire and I’m looking forward to working with our commercial team to make that a reality for more people living with the condition”, says Eric Timm, President, Global Commercial Operations and CEO, Neuromod USA.

The announcement comes following the launch of Lenire into the Spanish market in March as Neuromod continues to expand availability of the device throughout Europe. Earlier in the year the organisation launched Ótologie, its clinical service dedicated to tinnitus care.

Florian Elsaesser has been appointed Chief Strategy and Corporate Development Officer, assuming responsibility for the execution of Neuromod’s corporate strategy agenda.

Prior to joining Neuromod in 2020, Mr. Elsaesser held various executive positions for Sivantos and Siemens Audiology. Prior to Siemens Audiology’s acquisition by Private Equity fund EQT, Florian held senior financial roles managing global functions in finance and controlling. After the acquisition, Florian went on to hold senior business development and marketing roles in the newly rebranded Sivantos. In these roles, he managed the acquisition and integration of companies and coordinated global sales and marketing functions.

“Florian has been instrumental in our success so far to bring Lenire to as many people with tinnitus as possible and holds critical experience in corporate development that he will bring to our strategic ambitions. I’m delighted to be working with him closely as we look to further support underserved patient populations through our planned corporate agenda”, says Ross O’Neill.

“I’m looking forward to working with our dedicated global teams to progress our corporate development agenda to further support patient populations through best-in-class treatment interventions”, says Florian Elsaesser, Chief Strategy and Corporate Development Officer.

Lenire is a bimodal neuromodulation device which has shown in large-scale clinical trials to reduce the symptoms of tinnitus by combining mild electrical pulses to the tongue with sound stimulation(i). It’s currently available in eight countries in Europe through prescription by qualified healthcare professionals.

For more information please contact:

Neil Doyle
Global Director of Marketing,
Neuromod Devices
neil.doyle@neuromoddevices.com

About Neuromod Devices Ltd

Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe. For more information visit www.neuromoddevices.com.

About Lenire

Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical triali. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details about Lenire including a list of providers can be found at www.lenire.com.

Connect with Neuromod Devices Ltd

LinkedIn: linkedin.com/company/neuromod

Twitter: twitter.com/NeuromodDevices

Website: neuromoddevices.com

References

(i)Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)

Priothera – FDA and EMA Grant Orphan Drug Designation to mocravimod for the treatment of Acute Myeloid Leukemia (AML) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT)

• Mocravimod is being developed as a potential best-in-class adjunctive and maintenance therapy to enhance the curative potential of HSCT for AML patients

• A global registration-enabling Phase 2b trial assessing mocravimod in AML patients undergoing allogeneic HSCT is planned in H2 2022

Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator drug, mocravimod, today announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted orphan drug designation (ODD) to mocravimod for the treatment of Acute Myeloid Leukemia (AML) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). EMA’s ODD follows a recommendation from the Committee for Orphan Medicinal Products (COMP).

Florent Gros, Co-Founder and CEO of Priothera, commented: “The orphan drug designations we received for mocravimod from both the FDA and EMA are important milestones towards addressing the urgent, unmet needs of AML patients. Allogenic stem cell transplantation is the only potentially curative approach for AML patients but has unacceptably high mortality rates with current treatments. We are looking forward to initiating the global Phase 2b clinical trial with mocravimod in multiple centers in the US, Europe and Asia in the coming months.”

Mocravimod, a sphingosine 1 phosphate (S1P) receptor modulator which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of HSCT. Moreover, it has shown a clinically relevant benefit in an early clinical study in patients with hematologic malignancies undergoing HSCT.

A multicenter Phase 2b study evaluating the efficacy and safety of mocravimod as an adjunctive and maintenance therapy to HSCT in adult AML patients is planned for the second half of 2022. The study will include approximately 250 patients in several countries in Europe, the US and Asia, upon approvals from respective health authorities.

Orphan drug designation is reserved for medicines treating rare, life-threatening or chronically debilitating diseases.

About mocravimod

Mocravimod (also known as KRP203), is a novel, synthetic, sphingosine 1-phosphate receptor (S1PR) modulator with a long duration in the body. Phase 1 and Phase 2 trials successfully assessed mocravimod for safety and tolerability in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers. Mocravimod will be investigated in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogenic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates. Priothera leverages S1PR’s unique mode of action to maintain anti-leukemia activity - graft-versus leukemia (GVL) - while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogenic HSCT. This novel treatment approach – the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.

About Priothera

Priothera is leading the way in developing orally applied sphingosine 1 phosphate (S1P) receptor modulators for the treatment of hematological malignancies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues and not being immunosuppressants, thereby allowing for inhibition of graft-versus-host-disease (GvHD) while maintaining graft-versus-leukemia benefits in patients receiving HSCT.

Priothera which was founded in 2020 by an experienced team of drug development experts is headquartered in Dublin, Ireland. The Company is backed by international founding investors Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden) and EarlyBird Venture Capital (Berlin, Germany).

For more information please visit: www.priothera.com

Contacts

Priothera
Florent Gros, CEO
E: info@priothera.com

MEDiSTRAVA Consulting
Sylvie Berrebi, Sandi Greenwood, Frazer Hall
E: priothera@medistrava.com
T: +44 (0)7714 306525

AbbVie Acquires Syndesi Therapeutics, Strengthening Neuroscience Portfolio

Expands AbbVie's neuroscience portfolio, adding first-in-class modulators of the synaptic vesicle protein 2A, including lead molecule SDI-118 currently in Phase 1b studies

Novel mechanism will be evaluated for the potential to mitigate synaptic dysfunction associated with cognitive deficits across a range of neuropsychiatric and neurodegenerative disorders

AbbVie (NYSE: ABBV) today announced it has completed the acquisition of Syndesi Therapeutics SA, which will help to expand AbbVie's neuroscience portfolio. This acquisition gives AbbVie access to Syndesi's portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118. The mechanism is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer's disease and major depressive disorder.

"There is a major unmet need for new therapies that can help improve cognitive function in patients suffering from difficult-to-treat neurologic diseases," said Tom Hudson, M.D., senior vice president, R&D, chief scientific officer, AbbVie. "With AbbVie's acquisition of Syndesi, we aim to advance the research of a novel, first-in-class asset for the potential treatment of cognitive impairment associated with neuropsychiatric and neurodegenerative disorders."

The lead molecule, SDI-118, is a small molecule currently in Phase 1b studies, which is being evaluated to target nerve terminals to enhance synaptic efficiency. Synaptic dysfunction is believed to underlie the cognitive impairment seen in multiple neuropsychiatric and neurodegenerative disorders.

"We have been impressed with the vision of AbbVie's neuroscience R&D team, who share our view on the therapeutic potential of SDI-118 in a range of neurologic diseases," said Jonathan Savidge, chief executive officer, Syndesi Therapeutics. "I am delighted with the closing of this deal. It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Now, as part of AbbVie, the program is well positioned to move into later stages of clinical development."

Under the terms of the agreement, AbbVie will pay Syndesi shareholders a $130 million upfront payment with the potential for Syndesi shareholders to receive additional contingent payments of up to $870 million based on the achievement of certain predetermined milestones.

Advisors

Cleary Gottlieb Steen & Hamilton LLP acted as legal counsel to AbbVie. Goodwin Procter LLP acted as lead legal counsel, along with Deloitte Legal, Belgium, and Lazard acted as the exclusive financial adviser to Syndesi.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

About Syndesi Therapeutics

Founded in December 2017 and based in Belgium, Syndesi is a clinical stage biotechnology company pioneering the development of novel therapeutics that modulate synaptic function to relieve the symptoms of cognitive impairment. Syndesi's unique molecules act pre-synaptically to enhance synaptic efficiency by positively modulating the function of synaptic vesicle protein 2A (SV2A), which plays a central role in regulating neurotransmission.

Syndesi was created through a partnership between UCB Biopharma SRL and a syndicate of Belgian and international investors to further develop novel SV2A modulators that had been originally discovered by UCB. Syndesi's Series A financing was co-led by Novo Holdings together with Fountain Healthcare Partners, with participation from Johnson & Johnson Innovation – JJDC, Inc., SRIW (Société Régionale d'Investissement de Wallonie), V-Bio Ventures and Vives Fund, along with UCB Ventures. The company has also benefited from support from the Walloon Region. The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018.

Priothera Enters Loan Agreement of €17.5 Million with the European Investment Bank

Loan will further support the conduct of a global registration-enabling clinical trial with mocravimod for the treatment of Acute Myeloid Leukemia, and for expansion into additional cancer indications

Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator drug, mocravimod, today announces that it has entered a Loan Agreement of €17.5 million with the European Investment Bank (EIB). This loan will further support a European, US and Asian registration-enabling clinical trial with mocravimod in Acute Myeloid Leukemia (AML) patients receiving hematopoietic stem cell transplant (HSCT).

The loan facility of €17.5 million is divided into two tranches, the first of which is €10 million and unconditional. Priothera will request payment of the first tranche in 2022 to expand the clinical development of mocravimod and prepare for its commercial drug supply. The second tranche of €7.5 million is available upon achievement of specific manufacturing, clinical and regulatory milestones and will be used to finance clinical validation in CAR-T cancer indications.

Florent Gros, Co-Founder and CEO of Priothera, comments: “We are very grateful for EIB’s support, a major and high quality European financial institution, as the Company is at an inflection point of its clinical development and potential commercialization path. This financing allows Priothera to extend its financial visibility to 2024, allowing us to complete a global registration-enabling clinical trial, as well as exploring other blood cancer indications for mocravimod. This new funding tool will help reinforce Priothera’s global lead in developing S1P receptor modulators in oncology.”

Christian Kettel Thomsen, Vice-President of the EIB, said: “The European Investment Bank Group supports development of innovative and pioneering treatments and medicine by leading biotech and medtech companies in Ireland and across Europe. Priothera’s new drugs offer an opportunity to revolutionise treatment of leukaemia and other cancers and the EIB is pleased to agree to €17.5 million of new financing to accelerate the clinical development and commercialization of mocravimod.”

About mocravimod

Mocravimod (also known as KRP203), a propane-1,3-diol derivative, is a novel, synthetic, sphingosine 1-phosphate receptor (S1PR) agonist with long duration in the body. Phase 1 and Phase 2 trials successfully assessed mocravimod for safety and tolerability in several autoimmune indications. Promising data from a Ph1b/Ph2a clinical study with patients with haematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers. Mocravimod will be investigated in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving HSCT. Allogenic HSCT is the only potentially curative approach for AML patients but remains having unacceptably high mortality and morbidity rates with current treatments.

Priothera leverages S1PRs unique mode of action to maintain anti-leukaemia activity while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of HSCT. This novel treatment approach - the only S1PR modulator treating blood cancers - tackles a high unmet medical need that intends to add quality life to patients.

About Priothera

Priothera is leading the way in developing orally applied sphingosine 1 phosphate (S1P) receptor modulators for haematological malignancies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues and not being immunosuppressants, thereby allowing for inhibition of graft-versus-host-disease (GvHD) while enhancing graft-versus-leukaemia benefits in patients receiving HSCT.

Headquartered in Dublin, Ireland, Priothera was founded in 2020 by an experienced team of drug development experts Drs. Florent Gros, Stephan Oehen, Dhaval Patel, Christoph Bucher, Simone Seiter, Philippe Lievre and Brice Suire. Founding investors are Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden) and EarlyBird Venture Capital (Berlin, Germany).

For more information please visit: www.priothera.com

About the European Investment Bank (EIB)

The EIB is the European Union (EU) long-term financing institution and its shareholders are the 27 EU Member States. Its mission is to contribute to the integration, balanced development and economic and social cohesion of EU Member States. It borrows large volumes of funds from the capital markets and lends them with very favourable terms to support projects which contribute to the achievement of EU objectives. The EIB is working to put the EU at the forefront of the next wave of innovation, especially in the health sector. In response to the Covid-19 health crisis, the EIB has released € 6 billion for investments in the health sector to support medical infrastructure, additional research activities or other financing related to vaccines and treatments. As a European bank supporting the climate, the EIB is one of the main fund providers in the green transition towards a more low-carbon and sustainable growth model.

Contacts

Priothera
Florent Gros, CEO
E : info@priothera.com

MEDiSTRAVA Consulting
Sylvie Berrebi, David Dible, Sandi Greenwood, Frazer Hall
E: priothera@medistrava.com
T: +44 (0)7714 306525

XyloCor Therapeutics Expands Leadership Team with Accomplished Pharmaceutical Executives to Accelerate Clinical Development Programs and Drive Corporate Growth

• Elizabeth Tarka, M.D. appointed Chief Medical Officer

• A. Brian Davis named Chief Financial Officer

XyloCor Therapeutics, a clinical‑stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced that it has appointed Elizabeth Tarka, M.D. as Chief Medical Officer and A. Brian Davis as Chief Financial Officer. These experienced pharmaceutical industry executives will enhance the company’s clinical development, operational, and financial capabilities and drive its ongoing growth.

"I am delighted to welcome Liz and Brian to the leadership team at XyloCor," said Al Gianchetti, President and Chief Executive Officer. “Liz is a proven R&D leader who brings a strong track record managing late-stage clinical development programs with particular expertise in cardiovascular medicine. Brian will leverage his extensive management and finance experience in both private and public biotech companies to accelerate Xylocor’s strategic and corporate objectives. Their collective experience will drive XyloCor toward our objectives as we focus on advancing our pipeline of transformative gene therapies intended to improve the lives of people with cardiovascular disease.”

Executive Biographies

Elizabeth Tarka, MD – Chief Medical Officer

Dr. Tarka is a cardiologist with over 20 years of experience in the pharmaceutical and biotechnology industry. She has dedicated her career to the development of innovative therapies that improve human health. Dr. Tarka’s experience includes leadership roles across all phases of late-stage clinical development and a track record of effectively partnering with stakeholders to enable the successful execution of clinical trials. She joins the company from Idera Pharmaceuticals where she served as CMO. Before that, Dr. Tarka was Vice President, Clinical Development at Complexa, Inc., a clinical stage biopharmaceutical company focused on life-threatening fibrosis and inflammatory diseases. Earlier in her career, she served as Clinical Program Leader for Xarelto® (rivaroxaban) at Janssen Pharmaceuticals, where she was responsible for the design, implementation, and medical oversight for large multinational trials. Prior to her tenure at Janssen, Dr. Tarka worked at GlaxoSmithKline in the Metabolic Pathways and Cardiovascular Therapeutic Area. She has been on the faculty and had numerous major teaching and clinical responsibilities at the University of Pennsylvania and affiliated hospitals. She is trained in Cardiology and Internal Medicine and has published in a number of peer-reviewed journals. Dr. Tarka earned a BA in Biochemistry and an MD from the University of Pennsylvania where she also completed her residency and fellowship training.

A. Brian Davis– Chief Financial Officer

Mr. Davis joins XyloCor with a proven background as a seasoned financial executive, including over 15 years of experience as a CFO for publicly traded, commercial- and clinical-stage biopharmaceutical companies, and nearly 30 years as a financial professional in the life sciences industry. He has extensive expertise in fundraising, financial strategy, negotiating strategic transactions involving acquisition and disposition of commercial and clinical-stage assets, shareholder relations, and SEC accounting, reporting, and compliance. Mr Davis has raised over $600 million in public and private equity financings, including leading an initial public offering, and nearly $200 million in debt financings. Most recently, he was CFO at Verrica Pharmaceuticals, where he held managerial responsibility for executing equity and debt financings, analyst and shareholder relations, financial aspects of commercial launch preparation, business development, finance, accounting, tax, and treasury. Before that, Mr. Davis had similar duties as CFO at Strongbridge Biopharma plc, Tengion, Inc., and Neose Technologies, Inc. Mr. Davis is a Certified Public Accountant. He earned an MBA from The Wharton School, University of Pennsylvania and an undergraduate degree in Accounting from Trenton State College.

About XyloCor

XyloCor Therapeutics is a private, clinical‑stage biopharmaceutical company developing potential best‑in‑class gene therapies to transform outcomes for patients with cardiovascular disease. The company’s lead product candidate, XC001, is currently being investigated in a Phase 2 clinical trial for patients with refractory angina for which there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co-founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit www.xylocor.com.

Corporate and Investor Relations:

A. Brian Davis
XyloCor Therapeutics
brian.davis@xylocor.com
610-541-2056

Media Contact:

Mike Beyer
Sam Brown Inc.
mikebeyer@sambrown.com
312-961-2502

Neuromod launches Ótologie to provide specialist care service for tinnitus patients

Irish medical device company, Neuromod Devices Ltd, has launched Ótologie, a specialist healthcare service for people living with tinnitus. This new service will enable tinnitus patients, in Ireland and throughout Europe, to avoid waiting lists and give them immediate access to treatment for tinnitus.

The establishment of Ótologie follows a successful pilot of a telehealth service for tinnitus patients by Neuromod and the publication of analysis by the Irish Hospital Consultants Association which found that approximately 77,000 patients were on waiting lists for public ENT services. Through engagement with consultant ENTs, Neuromod estimates up to 15,000 of these are tinnitus patients.

In 2021, Neuromod piloted a telehealth service to treat tinnitus patients in Ireland and throughout Europe. This pilot complemented Neuromod’s in-person treatment services at its clinic in Dublin, allowing patients to attend appointments and proceed with treatment at the clinic or via video call according to their preference.

Due to the success of the pilot, which allowed patients to progress to treatment within days of contacting the service and avoid waiting lists for public ENT appointments, Neuromod established Ótologie to provide quick access to tinnitus care from qualified healthcare professionals who can prescribe a range of proven treatments including Lenire, Cognitive Behavioural Therapy (CBT), and hearing aids.

The service streamlines the typical healthcare journey for tinnitus patients, offering them next day appointments which they can attend online or in-clinic. Neuromod’s clinic, located at the Hermitage clinic in Dublin, has been renamed from Neuromod Medical to Ótologie in preparation for the launch of the service.

Tinnitus, a condition commonly known as ‘ringing in the ears’, affects between 10 and 15% of the global population and could affect up to 500,000 people in Ireland.

However, in a recent study more than 60% of GPs reported that they do not follow routine criteria for onward referral of tinnitus patients and expressed a need for more access to specialist resources for these patients, demonstrating the need for specialist care services for tinnitus, such as Ótologie, which people seeking treatment can contact directly or be referred to by their current physician.

Speaking on the launch of Ótologie, Dr Ross O’Neill, CEO of Neuromod Devices said: “Waiting lists for tinnitus patients are not only stressful for the patients themselves but they are also a burden on the health system. From publicly available figures and our engagement with the healthcare system we estimate that today, there are 15,000 people suffering from tinnitus on a waiting list to access specialist public ENT care.”

“Furthermore, recent research has shown that waiting times for an ENT referral can be up to four years in some parts of Ireland. This study also highlighted the distress these lengthy waiting lists put on people living with tinnitus. It also showed that GPs and ENTs alike acknowledged the need for better access to ENT or audiology services for tinnitus. With Ótologie, our vision is to tackle this significant healthcare challenge by enabling patients to get started with treatment as soon as possible from anywhere in the country or indeed Europe. Our long-term aim is to create the first globally recognised approach to tinnitus care and management.”

Ótologie’s team of audiologists and therapists, specifically trained in treating tinnitus, have extensive experience treating patients with evidence-based treatments. Following clinical best practices, they assess each patient and recommend a personalised treatment plan from options which include the Lenire tinnitus treatment device; Tinnitus Therapy (a form of Cognitive Behavioural Therapy or CBT); or hearing aids suitable for people with tinnitus.

Ótologie’s Head of Tinnitus Care, audiologist Anita Sayers said: “Our experience, since we opened the Neuromod Medical clinic in 2019, from talking to our patients is that there is a lot of frustration in the lack of a clearly defined tinnitus patient pathway in Ireland, as well as the lack of clinically effective treatment options for people living with this condition.”

She continued: “People who live with tinnitus are looking for credible, expert advice and treatment plans to help them manage the impact that bothersome tinnitus has on their day-to-day life. With Ótologie, our goal is to build a patient centered service to provide groundbreaking and evidence-based tinnitus treatments, coupled with the empathy that patients need to feel supported at every stage of their tinnitus journey. We are really excited to be able to expand our services and tinnitus care offerings, all under the new Ótologie name.”

The launch of Ótologie follows Neuromod’s establishment of its US subsidiary, Neuromod USA Inc. To date Neuromod has raised significant venture equity and debt financing to fund ongoing expansion of the availability of Lenire in Europe and the organisation’s FDA submission process in the US.

This funding has been led by Fountain Healthcare Partners, an international life science focussed venture capital fund which invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit.

Ótologie’s treatment options for tinnitus

• Lenire - Lenire, a non-invasive bimodal neuromodulation device, has been proven in large-scale clinical trials to soothe the symptoms of tinnitus. Lenire delivers mild electrical pulses to the tongue combined with sound played through headphones to drive long-term changes, or neuroplasticity, in the brain to treat tinnitus.

• Tinnitus Therapy - Tinnitus Therapy is a form of psychotherapy which aims to change a patient’s perception of their tinnitus and minimise its impact on their life.

• Hearing Aids for Tinnitus - Hearing loss is one of the most common causes of tinnitus and improving a patients hearing can improve their symptoms. Ótologie offers a range of hearing aids, and ongoing support.

About Ótologie

Ótologie is an effective, patient-centred service that provides ground-breaking tinnitus care to improve the lives of people living with this condition every day and it has been established to address the growing healthcare need for people with tinnitus.

Its specialist audiologists and psychotherapists, have extensive experience treating tinnitus patients with the latest evidence-based treatments. They follow clinical best practices to assess each patient and recommend a personalised treatment plan from treatment options such as of Lenire, tinnitus therapy (CBT), or hearing aids for tinnitus. Combining these treatment options and the company’s technology-led platform, which offers next day appointments, Ótologie’s vision is to create the first globally recognised approach to tinnitus care and management. For more information visit www.otologie.com.

References

*(i) 15,000 waiting list number is based on a 20% estimation of a recent study by the IHCA, stating there were 77,000 people on ENT waiting lists as of November 2021 - https://www.ihca.ie/news-and-publications/77000-people-on-ent-waiting-lists-some-waiting-up-to-five-years-%E2%80%94-cancer-diagnoses-could-be-missed-says-surgeon

*(ii) Kilroy, Naomi & Refaie, Amr. (2020). Tinnitus management in Ireland: a pilot study of general practitioners. Irish Journal of Medical Science (1971 -). 189. 1-11. 10.1007/s11845-020-02222-6.**

Mainstay Medical Announces Publication of Two-Year Patient Outcomes Data from ReActiv8-B Clinical Trial Demonstrating Long-Term Efficacy of ReActiv8® Restorative Neurostimulation™

Data shows compelling efficacy and safety, as well as improvement on all key measures of pain and disability as compared to the one-year study results

Mainstay Medical Holdings plc today announced the publication of the two-year patient outcomes data from its pivotal ReActiv8-B clinical trial. The data, published in the journal of the International Neuromodulation Society, Neuromodulation, confirm the efficacy and safety of ReActiv8 Restorative Neurostimulation, and also demonstrate compelling long-term durability and improvement over time on key outcome measures in the treatment of intractable chronic low back pain.

On virtually all key efficacy measures, the 2-year data showed improvements over the data from the patients’ 1-year visits. Of note:

Outcome measure 2-year result (N = 156) 1-year result (N = 176)

Patients reporting pain intensity (VAS score) reduced by 50% or more from baseline 71% 64%
Patients reporting a greater than 20-point reduction in Oswestry Disability Index 61% 57%
Patients reporting VAS score < 2.5 65% 52%
Patients taking opioids at baseline that voluntarily eliminated or reduced opioid use 60% 48%

Dr. Chris Gilligan, Director of the Brigham and Women’s Spine Center at Brigham and Women’s Hospital, and Assistant Professor of Anaesthesia, Harvard Medical School, said, “The recently published data from the ReActiv8-B clinical trial showed clinically meaningful improvements in both pain and function for patients with refractory chronic low back pain who received two years of neurostimulation. Pain scores in patients have decreased substantially from an average of 7.3 to 2.4 and are sustained for the duration of 2 years and longer with ongoing data collection. These long-term data are extremely important and encouraging given the chronic and refractory nature of this condition.”

“These impressive results represent an important milestone for Mainstay, as the profound improvements in patient outcomes we observed from baseline to 1 year to 2 years validate the restorative nature of the therapy and represent a new paradigm among treatments available to patients with intractable chronic low back pain,” said Jason Hannon, CEO of Mainstay Medical. “We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population, evidence which continues to expand through multiple clinical trials.”

The full publication can be downloaded free of charge at https://www.sciencedirect.com/science/article/pii/S1094715921063868. The ReActiv8-B trial patient cohort continues to be evaluated to generate additional data on longer-term efficacy.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the United Kingdom, and the United States.

About the ReActiv8-B Clinical Trial

The ReActiv8-B clinical trial is an international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from the FDA. A total of 204 patients with chronic low back pain refractory to physical therapy and medical management were implanted with ReActiv8 at leading clinical sites in the U.S., Europe and Australia and randomized 1:1 to therapy or control. In the treatment group, the ReActiv8 pulse generator was programmed to deliver electrical stimulation expected to elicit episodic contractions of the multifidus muscle. In the control group, the ReActiv8 device was programmed to provide a low level of electrical stimulation. Following assessment of the primary endpoint at 120 days, patients in the control group crossed over to receive levels of electrical stimulation similar to those in the treatment group.

Clinical trial funded by Mainstay Medical. Dr. Chris Gilligan, Principal Investigator of the trial, is a consultant of Mainstay Medical. Information about the study can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation™ system, ReActiv8®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.

Further information can be found at www.mainstaymedical.com.

Mainstay Medical Announces Appointment of Jeffrey Dunn and Eric Major to its Board of Directors

Mainstay Medical Holdings plc today announced the appointment of two new independent members to the company’s board of directors, Jeffrey Dunn and Eric Major. These appointments bring Mainstay’s total board membership to seven.

“We are pleased to welcome these two transformational business leaders as new independent directors on the Board,” said David Brabazon, Chairman of the Mainstay Board of Directors. “Their deep experience will be invaluable to Mainstay as we grow our business and pursue our mission to serve patients with intractable chronic low back pain.”

“As our business evolves and we continue to focus on commercial growth, broadening the industry expertise on our Board will help the company strategically and operationally,” said Jason Hannon, Mainstay’s Chief Executive Officer and Board member. “Both Jeff and Eric have strong track records of success leading medical device companies focused on back pain from the launch phase through maturity. They bring decades of leadership in key areas, such as commercial and reimbursement strategy, new product development and operations, that will be valuable to us as we continue to grow our ReActiv8 business in the U.S. and abroad.”

Mr. Dunn currently serves as the Executive Chairman of the Board of Directors of SI-BONE, Inc. (Nasdaq: SIBN), a medical device company dedicated to solving musculoskeletal disorders of the sacropelvic anatomy. Mr. Dunn co-founded the company and served as its President, Chief Executive Officer and Chairman of the Board of Directors from 2008 until April 2021. Mr. Dunn led the company through the launch and market growth of the iFuse proprietary minimally invasive surgical implant system as well as the company’s 2018 Nasdaq IPO, taking the company from inception to its current market cap of over $700 million. Prior to joining SI BONE, Mr. Dunn held multiple Chief Executive Officer positions in various other companies since 1994. Mr. Dunn received a B.A. from Colgate University and an M.B.A. from Babson College.

Mr. Major has more than 25 years of experience in the spine device industry as an entrepreneur, executive, chairman, and board member. In 2004 Mr. Major co-founded K2M Group Holding, Inc., a global leader in complex spine and minimally invasive medical device solutions, and led the company to $300 million in annual revenue and a Nasdaq IPO in 2014. K2M was acquired by Stryker Corporation for $1.4 billion in 2018, after which Mr. Major served as president of Stryker’s spine division until June 2021. Prior to starting K2M, in 1998 Eric co-founded American OsteoMedix Corporation, a global minimally invasive spine company that was acquired by Interpore Cross (now part of Zimmer Biomet). Mr. Major holds a B.S. from James Madison University.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation™ system, ReActiv8®, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.

Further information can be found at www.mainstaymedical.com.

Priothera Appoints Elisabeth Kueenburg M.D., as Chief Medical Officer

Dr. Kueenburg, former Clinical Development Lead at Celgene, a Bristol Myers Squibb Company, to advance clinical development of mocravimod in Acute Myeloid Leukemia patients undergoing allogeneic hematopoietic stem cell transplant.

Priothera Limited, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, announces the appointment of Elisabeth Kueenburg, M.D., as Chief Medical Officer. Dr. Kueenburg will lead the advancement of mocravimod into Phase 2b/3 clinical trials as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving hematopoietic stem cell transplantation (HSCT), and expansion of Priothera’s pipeline.

“The breadth of knowledge Elisabeth has gained working at Celgene, alongside her extensive clinical experience, makes her a crucial addition to our team,” said Florent Gros, Co-Founder and CEO of Priothera. “We are delighted to welcome Elisabeth during this exciting time as we look to progress mocravimod, into a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia receiving hematopoietic stem cell transplantation. The study is expected to begin in 2022.”

“I am pleased to join Priothera at such an important stage of its development,” said Dr. Kueenburg. “Mocravimod has the potential to address the significant unmet need of AML patients undergoing HSCT. I look forward to guiding mocravimod and future programs into the clinic and making an important contribution to Priothera’s future success.”

Dr. Kueenburg brings significant drug development and medical affairs experience from her years at Celgene where she most recently served as Clinical Development Lead. At Celgene she developed deep clinical development and medical affairs expertise, providing strategic insight and overseeing the coordination of multiple clinical trials, in the area of hematology and specifically in multiple myeloma. Furthermore, Dr. Kueenburg has supported the successful global launch of Celgene’s Revlimid.

Prior to her numerous roles at Celgene, Dr. Kueenburg spent more than 15 years in clinical practice and academic research specializing in oncology and hematology.

Dr. Kueenburg gained her Doctor of Medicine from the University of Vienna in Austria

About Priothera

Priothera is leading the way in developing orally applied sphingosine 1 phosphate (S1P) receptor modulators for hematological malignancies. S1P receptor modulators are known to largely reduce egress of T cells from lymphatic tissues and not being immunosuppressants, thereby allowing for inhibition of graft-versus-host-disease (GvHD) while enhancing graft-versus-leukemia benefits in patients receiving HSCT. Headquartered in Dublin, Ireland, Priothera was founded in 2020 by an experienced team of drug development and biotech experts.

Founding investors are Fountain Healthcare Partners (Dublin, Ireland), funds managed by Tekla Capital Management, LLC (Boston, Massachusetts), HealthCap (Stockholm, Sweden) and EarlyBird Venture Capital (Berlin, Germany).

For more information please visit: www.priothera.com

Neurent Medical Receives FDA Clearance for NEUROMARK™, a Novel Multi-Point Nerve Disruption Treatment for Chronic Rhinitis

Proprietary NEUROMARK™ system is the first in-office treatment indicated to disrupt symptom-causing nerve tissue for Chronic Rhinitis patients.

Neurent Medical, a company pioneering innovative treatments for chronic inflammatory sino-nasal diseases, today announced Food and Drug Administration (FDA) clearance of its proprietary NEUROMARK™ Rhinitis Neurolysis Therapy™ (RNT). The clearance gives clinicians access to an in-office treatment designed to create lesions to disrupt the posterior nasal nerves, for patients with chronic rhinitis.

Approximately one in four Americans suffer from chronic rhinitis1, a condition that results in persistent congestion, rhinorrhea (runny nose), sneezing and nasal itching caused by inflammation and swelling of the mucosal membrane in the nose. NEUROMARK™ RNT is designed with a unique flexible electrode array geometry to access and disrupt hard-to-reach posterior nasal nerves in a single placement.

“The FDA clearance of NEUROMARK™ RNT means otolaryngologists can now offer precise care to patients with chronic rhinitis, while avoiding the trial and error that often goes into treating this condition” said Marc Dubin MD, Scientific Advisor for Neurent Medical. “The truth is, medications, sprays and other intranasal procedures are often either ineffective or only offer short-term relief for patients suffering with chronic rhinitis. I look forward to being able to offer them an exciting new treatment option conveniently administered in a single in-office visit.”

NEUROMARK™ system is a novel multi-point nerve disruption treatment for chronic rhinitis. The system’s unique design, biofeedback monitoring features and advanced algorithmic controls enable the physician to simultaneously disrupt multiple nerve branches with a high degree of anatomical precision, safety, and patient comfort.

“It is well documented1 that chronic rhinitis can significantly decrease the quality of life for patients by adversely impacting their sleep quality, daily activity, mental health and overall wellbeing” said Neurent Medical CEO Brian Shields. “NEUROMARK™ addresses the limitations of other treatments and uses advanced technology to do so safely, gently and with ease. The market need is immense and underserved, and we are excited to bring our initial product offering to the market, providing symptom relief to as many patients as possible. We are equally as excited to continue our product pipeline development to address other sino-nasal inflammatory conditions and realize the full potential of the NEUROMARK™ platform.”

About Neurent Medical

Neurent Medical is pioneering innovative treatments for chronic inflammatory sino-nasal diseases by targeting and safely disrupting hyperactive autonomic nerves that drive underlying inflammation. Its proprietary NEUROMARK™ technology with a unique design and advanced algorithmic control, physicians can precisely target and safely disrupt multiple underlying nerve branches in a single procedure to alleviate Chronic Rhinitis symptoms and improve patient quality of life. The venture capital-backed company is headquartered in Galway, Ireland. For more information visit www.neurentmedical.com.