Priothera closes €30 million Series A financing to develop highly promising therapies for acute myeloid leukemia (AML)

Financing to advance mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, and potential best-in-class therapy for AML patients

Priothera Limited, a clinical stage company developing orally applied sphingosine 1 phosphate (S1P) receptor modulators for haematological malignancies, today announced that it has successfully closed a Series A financing round of €30 million led by Fountain Healthcare Partners with participation from co-lead investor HealthCap and funds managed by Tekla Capital Management, LLC as well as EarlyBird Venture Capital.

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogenic hematopoietic stem cell transplantation (HSCT) for treating AML. Priothera expects to generate further randomized clinical data in high risk AML patients with this Series A funding round.

Mocravimod has already been extensively tested in multiple immunologic indications and has shown survival benefit in an early clinical study evaluating acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) patients undergoing hematopoietic stem cell transplantation (HSCT). Priothera acquired mocravimod from KYORIN Pharmaceutical Co., Ltd.

Following the closing of the financing, Florent Gros (Priothera's Co-Founder and CEO), Dr. Dhaval Patel (Priothera's Co-Founder and CSO at UCB), Dr. Manus Rogan (Fountain Healthcare Partners Co-Founder and Managing Director), Dr. Mårten Steen (Partner at HealthCap), Dr. Henry Skinner (Senior Vice President at Tekla Capital Management, LLC) and Lionel Carnot (Partner at EarlyBird Venture Capital), have joined the Board of Directors.

Florent Gros, Co-Founder and CEO of Priothera, commented, "We are delighted to welcome this terrific syndicate of investors, who share our passion, commitment, and vision for advancing Priothera's potentially best-in-class new therapy, mocravimod, in patients with acute myeloid leukemia and other hematologic malignancies. Allogenic stem cell transplant is the only potentially curative approach for AML patients, but has unacceptably high mortality with current treatments. We are excited about mocravimod which has a unique mechanism of action and clinical proof of concept demonstrating its ability to improve survival outcomes for this devastating disease."

Dr. Dhaval Patel, Co-Founder and Board Director of Priothera, who previously led Research Europe and the Autoimmunity, Transplantation and Inflammation Disease Area at Novartis, known for its success in developing other S1P receptor modulators, stated, "Mocravimod is an outstanding, well-characterized and well-behaved S1P receptor modulator that is well-suited for clinical development and commercial manufacturing. Based on the clinical results to date, mocravimod has the potential to be a best-in-class therapy to decrease the morbidity and mortality associated with HSCT for AML. I have high hopes that Priothera can make an impactful difference for these patients."

Commenting on the launch of the company, Dr. Manus Rogan, Chairman of Priothera added, "The Priothera team has identified and validated a novel commercial opportunity for an S1P receptor modulator allowing the company to complete this significant Series A funding round. With their extensive expertise and capabilities I am confident that Florent and the team are uniquely placed to successfully generate further clinical data to highlight the significant potential of mocravimod."

Priothera
Priothera is leading the way in developing orally applied sphingosine 1 phosphate (S1P) receptor modulators for haematological malignancies. S1P receptor modulators have been suggested to largely reduce egress of T cell subsets from lymphatic tissues allowing for dual inhibition of graft-versus-host-disease (GvHD) and enhancing graft-versus-leukemia benefits in patients receiving allogenic stem cell transplant.

Headquartered in Dublin, Ireland, Priothera was founded in 2020 by Drs. Florent Gros and Dhaval Patel. Joining the founding team are the experienced industry executive, Dr. Christoph Bucher, Dr Simone Seiter, 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

KYORIN Pharmaceutical Co., Ltd.

Trusted among patients and professionals in the medical industry, KYORIN Pharmaceutical strives to be a company that contributes to public health and is recognized as a key player with social significance, by improving its presence in specific therapeutic areas through global discovery programs of novel drugs. KYORIN Pharmaceutical uses a franchise customer strategy where its marketing efforts are focused on respiratory, otolaryngology and urology indications. In drug discovery, Kyorin is deploying 'selection and concentration' approach and is promoting activities aimed at identifying first-in-class drug candidates. Actively searching for and introducing external drug discovery themes as well as multi-tiered program development are at the center of Kyorin's efforts.

Fountain Healthcare Partners

Fountain Healthcare Partners is a life science focused venture capital fund with EUR 300 million (USD 354 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain's main office is in Dublin, Ireland, with a second office in New York. fh-partners.com

HealthCap

HealthCap is a family of venture capital funds investing globally in life sciences. With more than EUR 1 billion raised since the start in 1996, HealthCap is one of the largest specialized providers of venture capital within life sciences in Europe. The investment strategy focuses on diseases with high-unmet medical needs and breakthrough therapies that have the potential to be transformative and change medical practice, and the lives of patients suffering these conditions. Over the years HealthCap has backed and built more than 100 companies, taken more than 40 companies public and done numerous trade sales.

Tekla

Tekla Capital Management LLC is a registered investment adviser based in Boston, Massachusetts and is the investment adviser for four closed-end funds, Tekla Healthcare Investors, Tekla Life Sciences Investors, Tekla Healthcare Opportunities Fund and Tekla World Healthcare Fund. The Funds predominately invest in the securities of public and private healthcare companies.

Earlybird

Earlybird is a venture capital investor focused on European technology companies. Founded in 1997, Earlybird invests in all growth and development phases of a company. Amongst the most experienced venture investors in Europe, Earlybird offers its portfolio companies not only financial resources, but also strategic and operational support as well as access to an international network and capital markets. Earlybird manages separate funds focussing on digital technologies in Eastern and Western Europe as well as healthcare across Europe. With over EUR 1 billion under management, seven IPOs and 24 trade sales, Earlybird is one of the most successful venture capital firms in Europe.

Contacts

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

Citigate Dewe Rogerson
Sylvie Berrebi, David Dible, Frazer Hall
E: priothera@citigatedewerogerson.com
T: +44 (0)7714 306525

Neuromod Publishes Results of Large-Scale Tinnitus Clinical Trial in Peer-Reviewed Top-Tier Scientific Journal

• Clinical trial concludes that bimodal neuromodulation combining sound and electrical stimulation of the tongue can significantly reduce tinnitus symptoms, and therapeutic effects can be sustained for up to 12 months post-treatment.

• 77.8% of participants said they would recommend the Company’s Lenire® device to others with tinnitus.

• 80.1% of treatment compliant participants experienced continued improvement in tinnitus symptom severity when evaluated 12-months post-treatment.

Neuromod Devices Limited (“Neuromod”), the Irish medical device company specialising in the treatment of chronic tinnitus, commonly described as ‘ringing in the ears’, has published the results of the Company’s TENT A1 (Treatment Evaluation of Neuromodulation for Tinnitus) clinical trial in this week’s edition of Science Translational Medicine in a paper titled: ‘Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study’.

The clinical trial was conducted between 2016 and 2019 and was designed to track changes in tinnitus symptom severity. The trial investigated the bimodal neuromodulation approach, using Neuromod’s non-invasive stimulation device that delivers sound to the ears and electrical stimulation to the tongue.

The study represents the largest and longest followed-up clinical trial ever conducted in the tinnitus field with 326 enrolled participants, providing evidence regarding the safety, efficacy and patient tolerability of bimodal neuromodulation for the treatment of tinnitus. 86.2% of treatment compliant participants reported an improvement in tinnitus symptom severity when evaluated after 12 weeks of treatment, with many experiencing sustained benefit 12 months post-treatment.

The study was conducted at the Wellcome Trust-HRB Clinical Research Facility, St. James’s Hospital, Dublin, Ireland and the Tinnituszentrum of the University Regensburg, Germany. There were consistent therapeutic outcomes across both clinical sites, with no SAEs Serious Adverse Events (SAEs related to the treatment and a high satisfaction rate across a large cohort of participants. A Medical Research Organization (NAMSA, Minneapolis, Minnesota, USA) guided and assisted the close-out process of Neuromod’s clinical trial.

The tinnitus treatment device, now branded as Lenire®, which was used in the study was developed by Neuromod and consists of wireless (Bluetooth®) headphones that deliver sequences of audio tones layered with wideband noise to both ears, combined with electrical stimulation pulses delivered to 32 electrodes on the tip of the tongue by a proprietary device trademarked as Tonguetip®. The timing, intensity and delivery of the stimuli are controlled by an easy to use handheld controller that each participant is trained to use. Before using the treatment for the first time, the device is configured to the patient’s hearing profile and optimised to the patient’s sensitivity level for tongue stimulation.

For the trial, participants were instructed to use the Lenire® device for 60 minutes daily for 12 weeks. Out of 326 enrolled participants, 83.7% used the device at or above the minimum compliance level of 36 hours over the 12-week treatment period. For the primary endpoints, participants achieved a statistically and clinically significant reduction in tinnitus symptom severity.

When treatment was completed, participants returned their device and were assessed at three follow-up visits up to 12 months. 66.5% of participants who filled out the exit survey (n=272) affirmed they had benefited from using the device and 77.8% (n=270) said they would recommend the treatment for other people with tinnitus.

Participants in the study were screened and selected based on a pre-defined list of inclusion and exclusion criteria to ensure the trial had a wide distribution sample of the tinnitus population. More information on the criteria can be found on https://www.clinicaltrials.gov/ using the identifier NCT02669069 and the full paper can be accessed here: https://www.neuromoddevices.com/tenta1results.

Dr Ross O’Neill, Founding CEO of Neuromod commented: “We are delighted to announce the publication of positive results from our TENT-A1 clinical trial, which has shown significant improvements in tinnitus symptoms in patients using our unique Lenire® device. There is a globally recognised clinical need for evidence-based treatments for tinnitus, such as Lenire®, due to the lack of effective options for this debilitating condition. Neuromod is proud to be at the cutting edge of efforts to research and develop new solutions that can contribute to solving this chronic condition that affects 10-15% of the population worldwide. We are committed to continuing our research in the field and to advance our unique chronic tinnitus treatment technology”.

Hubert Lim, Chief Scientific Officer of Neuromod commented: “I am truly proud of our Company’s ability to perform such a large-scale randomised clinical trial in two countries, enrolling 326 participants to demonstrate the safety and efficacy of a new solution for tinnitus. This study tracked the post-treatment therapeutic effects for 12 months, which is a first for the tinnitus field in evaluating the long-term outcomes of a medical device approach. The outcomes are very exciting and I look forward to continuing our work to develop a bimodal neuromodulation treatment to help as many tinnitus sufferers as possible.”

About Neuromod Devices Limited

Neuromod Devices Limited (“Neuromod”), headquartered in the Digital Hub, Dublin, Ireland, is a medical technology company, specialising 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 company was founded in 2010, by Dr. Ross O’Neill. 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 for which no standard of care has yet been established. Neuromod’s tinnitus treatment device Lenire® has been commercialised in Europe and is available in Ireland, Belgium and Germany. Tinnitus affects between 10 and 15% of the global population, and the lives of at least 1 in every 100 people worldwide are severely compromised because of the incessant nature of the illusory sound that is often described as a ringing or buzzing in the ears.

www.NeuromodDevices.com

About Lenire®

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

About Science Translational Medicine

The Science family of journals is published by the American Association for the Advancement of Science (AAAS), the world’s oldest and largest general science organization. The Science magazine has been at the centre of important scientific discovery since its founding in 1880, and continues to publish the very best in research across the sciences, with articles that consistently rank among the most cited in the world. Science Translational Medicine is an essential platform for peer-reviewed, multidisciplinary research driving the latest medical advances to complement the discoveries in the Science magazine.

Contacts

FTI Consulting | Media Relations

Melanie Farrell
Aline Oliveira
T: +353 1 6633686
T: +353 86 401 5250
neuromod@fticonsulting.com

Syndesi Therapeutics progresses development of SDI-118 for cognitive impairment and expands its series A financing

Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, provides an update on the clinical development of its lead molecule, SDI-118, and announces an extension of its series A financing.

Following successful completion of a first in human single ascending dose and PET occupancy study of SDI-118, dosing in two additional Phase I studies has been completed and the data are being analyzed:

• A multiple ascending dose study to examine the safety, tolerability, and pharmacokinetics of SDI-118, following 14 days of dosing in healthy young and healthy elderly subjects.

• A single dose cross-over study investigating the effects of SDI-118 on EEG (electroencephalogram) recordings of brain activity

Results from both these studies are expected before the end of 2020.

Based on the promising progress to date, all Syndesi's existing investors - Novo Holdings, Fountain Healthcare Partners, Johnson & Johnson Innovation – JJDC, Inc., SRIW, V-Bio Ventures and Vives Fund, together with UCB Ventures - have committed to an additional tranche of Series A financing to conduct a second clinical proof-of-principle study. This study will focus on remitted depressed subjects who report a perceived deficit in cognition. Concurrently a study in elderly subjects reporting memory problems will also be run. These studies are planned to commence during H1 2021.

Commenting on the progress made with SDI-118 development and the extended financing Jonathan Savidge, CEO of Syndesi, said “We continue to be encouraged by the profile of SDI-118 as a potential treatment for a number of CNS disorders with cognitive impairment. The additional financing demonstrates the commitment from our existing investors, and allows the company to conduct a second clinical proof of principle study to more fully explore the potential benefits of SDI-118. We look forward to our next important milestones: receiving the full results from the further Phase I studies, and then commencement of two clinical proof of principle studies”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. Syndesi is investigating the potential of these molecules to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well as other conditions such as major depression and cognitive impairment associated with schizophrenia. The lead molecule, SDI-118, has successfully completed a First-in-Human Phase I study which demonstrated target engagement with PET imaging. The Phase I program has been supported in part by funding from the Walloon Region. The company is financed by a top tier syndicate of international and Belgian investors: Novo, Fountain Healthcare Partners, Johnson & Johnson Innovation – JJDC, Inc., SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund, along with UCB Ventures. Syndesi’s financing from its extended Series A round together with non-dilutive funding from the Walloon Region totals in excess of €26M.

Inotrem expands its Leadership Team with the appointment Delphine Joyeux as Director of Regulatory Affairs and Quality Assurance and of Simon Lambden as Head of Medical Science

Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway, announced today the appointment of Delphine Joyeux as Director of Regulatory Affairs and Quality Assurance and Simon Lambden as Head of Medical Science.

Delphine Joyeux brings 20 years of leadership experience in worldwide Regulatory Affairs and Product Development with a global vision across all disciplines of product development. She will report to Chief Development Officer, Margarita Salcedo-Magguilli. Through this newly created position, Delphine will be responsible for developing and implementing the firm’s regulatory strategies. She will also be in charge of implementing and supervising quality management for the firm. Before joining Inotrem, Delphine was Head of Regulatory Affairs at AB Science. She started her career at Boehringer-Ingelheim, and over the years served both in large global pharmaceutical companies such as Laboratoires Servier, Pfizer and Onxeo. Delphine graduated in 1997 from the School of Pharmacy Paris Sud.

Simon Lambden brings extensive experience in the field of clinical and academic Intensive Care and Internal Medicine. He has completed specialist training in anaesthesia and intensive care alongside which his doctoral and postdoctoral research explored the mechanisms underlying critical illness, work for which he has secured a number of prizes. Simon will report to Dr. Jean-Jacques Garaud, CEO of Inotrem. Through this newly created position, Simon will be responsible for the medical supervision of all ongoing and future clinical research activities at Inotrem. He will also be the safety officer for the products portfolio. Simon is a Clinical Research Associate in Intensive Care Medicine at the University of Cambridge, and an Honorary Consultant in Intensive Care Medicine at Cambridge University Hospitals NHS Foundation Trust.

“We are thrilled to welcome such talented individuals in our leadership team and look forward to their guidance and contributions as we advance our immunotherapy products pipeline. We started collaborating with Simon during Inotrem’s Covid-19 Phase II clinical trial that was launched a few weeks ago and are excited to have him onboard as we are accelerating our development. Delphine has successfully spearheaded regulatory and quality efforts in a number of global biopharmaceutical companies, where she managed European and US clinical trial applications, INDs and marketing authorizations, and will bring great value to the team”, declares Jean-Jacques Garaud, CEO of Inotrem.

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. 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. Inotrem belongs to the French Tech 120 program which has been set up by the French President and the Prime Minister to support the development of start-ups with top growth potential. www.inotrem.com

Media contact for Inotrem

Anne REIN

Strategies & Image (S&I)

anne.rein@strategiesimage.com

+33 6 03 35 92 05

Inflazome announces acquisition by Roche

• Inflazome is a pioneering inflammasome company developing orally available NLRP3 inflammasome inhibitors to address clinical unmet needs across a wide variety of inflammatory diseases

• Acquisition of Inflazome gives Roche full rights to the Inflazome portfolio

• Activation of the NLRP3 inflammasome in the body is implicated in many diseases caused by chronic, uncontrolled inflammation

• Inflazome shareholders received €380 million upfront, and are eligible to receive additional milestone payments

Dublin (IE), Cambridge (UK): Inflazome announced today that it has closed a share purchase agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) in which Inflazome’s shareholders received an upfront payment of €380 million, and are eligible to receive additional contingent payments to be made based on the achievement of certain predetermined milestones.

Inflazome was founded in 2016 by leading medical researchers Prof Matt Cooper (University of Queensland, Australia) and Prof Luke O’Neill (Trinity College Dublin, Ireland). The company is a leader in the development of inflammasome inhibitors.

The acquisition gives Roche full rights to Inflazome’s entire portfolio which is composed of clinical and preclinical orally available small molecule NLRP3 inhibitors. Roche intends to further develop NLRP3 inhibitors across a wide variety of indications with high unmet medical need.

Matt Cooper, Chief Executive Officer, Inflazome, commented: “We are delighted to close this deal with Roche, an outstanding pharmaceutical company with a broad commitment to multiple indications. With Inflazome now part of the Roche organization, Inflazome’s pioneering molecules are well positioned to be developed quickly and effectively so they can help patients suffering from debilitating diseases.”

Manus Rogan, Chairman and co-founding investor of Inflazome, said: “It has been a privilege to work alongside Matt, his team and my co-investors. The Company, which was established just four years ago, developed a portfolio of clinical and pre-clinical molecules with a lean, highly experienced team and limited invested capital.”

Lazard acted as financial advisor and Goodwin Procter and Byrne Wallace acted as legal counsel to Inflazome.

About Inflazome

Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH. Inflazome has a portfolio of orally available small molecule NLRP3 inhibitors, with lead molecules having successfully completed Phase I clinical trials, as well as several high potential earlier-stage programmes.

Inflazome has raised €55m in Venture Capital financing from leading investors Forbion, Longitude Capital, Fountain Healthcare Partners and Novartis Venture Fund.

Inflazome is headquartered in Dublin, Ireland.

About the NLRP3 Inflammasome

Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.

Contacts

Inflazome

Dr Jeremy Skillington | VP Business Development

E: j.skillington@inflazome.com

Media

FTI Consulting

UK & International | Ciara Martin/Tim Stamper

T: +44 20 37271000

Ireland & International | Jonathan Neilan/Patrick Berkery

T: +353 1 7650800

E: StratCommEMEAInflazome@fticonsulting.com

Bayer to acquire UK-based biotech KaNDy Therapeutics Ltd.

• Further expansion of Bayer’s drug development pipeline in Women’s Healthcare

• Upfront consideration of USD 425 million and additional potential consideration in the form of milestone payments

Bayer, a global leader in women’s healthcare, and KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, today announce that Bayer will acquire KaNDy Therapeutics Ltd. to expand its drug development pipeline in women’s healthcare.

Under the terms of the agreement Bayer will pay an upfront consideration of USD 425 million, potential milestone payments of up to USD 450 million until launch followed by potential additional triple digit million sales milestone payments. Closing is subject to customary conditions, in particular anti-trust approval, and is expected by September 2020.

The acquisition of KaNDy Therapeutics Ltd. is another important milestone in augmenting Bayer’s own women’s healthcare portfolio through strategic collaborations and agreements.

Morgan Stanley is serving as financial advisor to Bayer, while Linklaters is serving as legal counsel. Goldman Sachs International is serving as financial advisor to KaNDy Therapeutics Ltd., while Goodwin is serving as legal counsel.

Bayer Contact:
Phone +44 (0)118 206-3977
Email: communications.ukireland@bayer.com

KaNDy Therapeutics Ltd. Contact:
Phone +44 (0)7885 715 857
Email: kandyTherapeutics@consilium-comms.com

Inotrem receives clearance from French, Belgian and US authorities to launch a Phase II clinical trial aimed at assessing nangibotide in mechanically ventilated patients with COVID-19

Inotrem’s clinical study on Covid-19 was selected by the French government to be part of its €78 M action plan aimed at reinforcing the countries’ research capabilities for therapeutic solutions.

Pre-clinical studies have demonstrated that nangibotide has a positive effect on controlling inflammatory syndromes and restores an appropriate immune response by targeting the TREM-1 pathway which is activated in patients suffering from COVID-19.

Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway, announced today that it has obtained authorization to launch its phase IIa clinical trial in COVID-19 patients in France, Belgium and the USA.

For this study, Inotrem received a non-dilutive funding as part of the call for proposals PSPC Covid, financed by the Investments d’Avenir Program which managed on behalf of the French government by Bpifrance, France’s public investment bank. Inotrem with its partners the CHRU of Nancy and the CHU of Limoges, was one of the 6 French biotech companies who benefited from this programme to support the research and development of therapeutic solutions targeting COVID-19.

The goal of this first exploratory study is to determine the safety and tolerability and potential signals of efficacy of nangibotide in critically ill patients with COVID-19 with inflammatory syndromes. The objective of this project is to have a positive impact on the severity of the respiratory failure, reduce duration of mechanical ventilation, length of stay in ICU and reduce mortality. Sixty patients will be enrolled in Europe and in the United States. This study follows an observational study in 27 patients, conducted by Prof. Sébastien Gibot at the CHRU of Nancy, which showed an increased expression of the TREM-1 pathway in severe COVID-19 patients. TREM-1 is an immunomodulatory receptor expressed on innate immune cells which amplifies and maintains inflammation.

Previous clinical studies with nangibotide demonstrated its safety and tolerability in patients suffering from septic shock, which is also characterized by an acute inflammatory syndrome. Pre-clinical models have shown that nangibotide inhibits the amplification of the immune response caused by the activation of TREM-1 and was able to restore appropriate inflammatory response, vascular function, and improved survival in septic shock models. Inotrem is currently conducting a Phase IIb trial (ASTONISH) to treat septic shock patients with nangibotide in 6 European countries and the United States. It is also developing, with Roche Diagnostics, a companion diagnostic test to identify patients more likely to benefit from its nangibotide treatment. Coronavirus disease 2019 is a new pandemic disease that arises as a consequence of infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The optimum treatment strategy in the management of critically ill patients with COVID-19 continues to evolve and, in addition to supportive therapies such as mechanical ventilation, vasopressors and renal replacement therapy, may include immunomodulatory approaches, such as nangibotide, in patients with severe disease.

Professor Sébastien Gibot, Nancy University Hospital and coordinating investigator said “We observed that the TREM-1 pathway was activated in severe forms of COVID-19. Nangibotide is a TREM-1 inhibitor and has the potential to restore an appropriate immune response. We are hoping to demonstrate that nangibotide will reduce the duration of hospitalization and mortality of critically ill patients suffering from COVID-19”.

Jean-Jacques Garaud, CEO of Inotrem, declared: “We are very pleased with both the granting of this financial support and the clearance to start our clinical trial. The French administration has been very effective in working in a coordinated and rapid fashion.”

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

About TREM-1 pathway

TREM-1 pathway is an amplification loop of the immune response that triggers an exuberant and hyperactivated immune state which is known to play a crucial role in the pathophysiology of septic shock and acute myocardial infarction. Today, there is an increasing number of publications indicating that the TREM-1 pathway is also implicated in chronic inflammatory diseases.

About Nangibotide

Nangibotide is the formulation of the active ingredient LR12, which is a 12 amino-acid peptide prepared by chemical synthesis. LR12 is a specific TREM-1 inhibitor, acting as a decoy receptor and interfering in the binding of TREM-1 and its ligand. In preclinical septic shock models, nangibotide was able to restore appropriate inflammatory response, vascular function, and improved animals’ survival post septic shock.

About ASTONISH Study

The Efficacy, Safety and Tolerability of nangibotide in Patients with Septic Shock (ASTONISH) phase IIb trial is a Randomized, Double-blind, Placebo Controlled Dose Selection Study that will be performed Europe and the US. Four hundred and fifty patients are planned to be included in this study in 48 clinical sites. The study will compare the effect of nangibotide at two different doses versus standard of care.

About Bpifrance

Bpifrance is the French national investment bank: it finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extrafinancial services (training, consultancy.). to help entrepreneurs meet their challenges (innovation, export…). For more information, please visit: www.bpifrance.fr and presse.bpifrance.fr - Follow us on Twitter: @Bpifrance - @BpifrancePresse

About French Strategic Investment Program

Endowed with 57 billion euros, the “French Strategic Investment Program” (PIA), lead by the General Secretary for Investment under the authority of the Prime minister, has been implemented to finance innovative and promising investments all over the territory, in order to allow France to increase its potential for long-term growth and jobs creation. The third component of the PIA, endowed with 10 billion euros, is part of the 57 billion euros Grand Plan d’Investissement (GPI) committed by the Government in 2017 and for a five years period in order to support structural reforms and respond to four major challenges in France : carbon neutrality, better access to employment, competitiveness through innovation and building the digital state.

Media contact for Inotrem

Anne REIN

S&I

anne.rein@strategiesimage.com

+33 6 03 35 92 05

FDA Grants Orphan Drug Designation for Inflazome’s Inzomelid for the Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)

Inzomelid is a potent, selective, orally-available, brain-penetrant NLRP3 inflammasome inhibitor intended for treatment of debilitating inflammatory diseases.

Inflazome announced positive Phase Ib results with Cryopyrin-Associated Periodic Syndrome (CAPS), an autoinflammatory orphan disease driven by a mutated NLRP3 inflammasome, earlier this year.

Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces that it has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for Inzomelid in the treatment of Cryopyrin-Associated Periodic Syndrome (CAPS).

Orphan Drug Designation is an important regulatory milestone granted to drugs that are intended to treat rare diseases and conditions, such as CAPS. CAPS is a rare, autoinflammatory orphan disease driven by a mutation affecting the NLRP3 inflammasome. Activation of the NLRP3 inflammasome is implicated in many diseases caused by chronic, harmful inflammation. Inflazome is looking to address such inflammation with one of its investigative drugs, Inzomelid, a potent and selective inhibitor of the NLRP3 inflammasome that can be taken orally.

In March 2020, Inflazome announced positive results with Inzomelid in CAPS, alongside the completion of a broader Phase I study that demonstrated excellent safety, tolerability and pharmacokinetics in healthy subjects. A follow-on Phase II trial is planned for this year to develop the dose for CAPS patients.

Dr. Thomas Jung, Chief Medical Officer, Inflazome, commented, “Receiving Orphan Drug Designation from the FDA is a validation of one of our investigative drugs, Inzomelid, and the pioneering work that we have done with the NLRP3 inflammasome since our foundation. Activation of NLRP3 is implicated in a very wide spectrum of diseases, of which CAPS is just one. Today’s news is a positive development for the CAPS patient community, for whom there are currently limited treatment options. We look forward to further developing Inzomelid and initiating our Phase II study in CAPS later this year.”

About Inflazome

Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH.

Inflazome has two clinical-stage investigational drugs. Inzomelid is under development as an orally available, brain-penetrant drug and Somalix is under development as an orally available, peripherally-restricted drug. Both will address clinical unmet needs in inflammatory conditions.

Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia. To learn more visit: inflazome.com

About the NLPR3 Inflammasome

Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.

About Cryopyrin-associated periodic syndromes

Cryopyrin-associated periodic syndromes (CAPS), also called cryopyrin-associated autoinflammatory syndromes, are three diseases related to a defect in the NLRP3 gene. CAPS encompasses neonatal onset multisystem inflammatory disease (NOMID), Muckle-Wells syndrome (MWS) and familial cold autoinflammatory syndrome (FCAS). The differences in these diseases lie in their severity and the organs involved.

About Orphan Drug Designation

The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain

• U.S. commercialization expected to begin in the first half of 2021

• Continues positive momentum for Mainstay, with increasing commercial footprint in Europe and expected launch in Australia in early 2021

Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Premarket Approval (PMA) application for ReActiv8®, its implantable neurostimulation system to treat intractable chronic low back pain.

Jason Hannon, CEO of Mainstay, said: “I am so proud of our team and the dedicated physicians who managed our clinical trials and cared for their patients. We are thrilled to receive FDA approval of ReActiv8, which is designed to be a restorative treatment and represents a new option for patients suffering with chronic low back pain. This disease affects millions of people around the world, and our clinical data demonstrates that ReActiv8 therapy provides progressive improvements in pain and disability over time, both in magnitude of effect and the proportion of patients who benefit from the treatment. This therapy has the potential to improve quality of life for the most severely-affected patients, and we look forward to making it available to U.S. patients and physicians beginning in the first half of 2021. This will build upon our growing business in Europe and our upcoming launch in Australia.”

“This milestone is the culmination of a development process over many years,” continued Mr. Hannon. “I would like to thank every member of our team, past and present, and in particular our clinical investigators, their teams and clinical study patients for their support and contributions.”

Dr. Chris Gilligan, Chief, Division of Pain Medicine, Department of Anaesthesiology, Perioperative and Pain Medicine, Brigham & Women’s Hospital, Assistant Professor of Anaesthesia, Harvard Medical and Principal Investigator of the pivotal ReActiv8-B study, said: “ReActiv8 fills an important unmet clinical need of patients suffering from chronic low back pain. Patients indicated for ReActiv8 therapy have generally tried numerous other treatments, including physical therapy and pain medications, and many are on long-term opioids to manage their pain. I have seen ReActiv8 provide durable improvements in back pain, the disabling effects of back pain, and quality of life. I am proud to have served as Principal Investigator of this landmark trial, and I look forward to sharing this experience with my physician colleagues who want to start using ReActiv8 in their patients.”

Dr. Robert Levy, a prominent neurosurgeon and pioneer in the field of neuromodulation, commented: “ReActiv8 represents a new treatment category for this severely-affected patient population. The use of neuromodulation to target underlying functional and motor-control issues in patients with musculoskeletal back pain can address a large unmet clinical need. ReActiv8 is designed as a restorative therapy for those suffering from musculoskeletal pain and does not compete with other forms of neuromodulation such as spinal cord stimulation. These patients are difficult for clinicians to treat with current therapy options, which is why so many of them take opioids to manage their pain. Having been part of the neuromodulation field for so long, I am really impressed by this particular innovation and I look forward to its adoption in clinical practice.”

The FDA approval grants Mainstay the right to market ReActiv8 in the United States as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery.

The FDA approval of ReActiv8 is primarily based on results from the ReActiv8-B clinical study, a pivotal 204-patient, international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from FDA.

Based on the FDA approval, Mainstay is refining its commercial launch plans for ReActiv8 in the U.S., including the build out of the commercial team, inventory procurement and related matters, as well as evaluating the financial resources necessary to fund its planned activities. Mainstay intends to host an investor event later this year to provide an update on its commercial plans for ReActiv8.

About ReActiv8®

ReActiv8 is an active implantable medical device designed to treat people with chronic low back pain (CLBP). ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. This nerve supplies the lumbar multifidus muscle, a key stabilizing muscle of the low back. Reactiv8’s stimulation of the nerve elicits contraction of the muscle, which can lead to improvement in CLBP and its disabling effects.

Low back pain is the number one cause of years lived with disability worldwide and a leading cause of activity limitation and work absence throughout much of the world, imposing a high economic burden on individuals, families, communities, industry and governments. While treatment options exist for patients with CLBP of a predominantly neuropathic origin, for the large portion of patients whose pain is predominantly nociceptive (or mechanical) in nature there are few therapies beyond drugs and injections, both of which merely mask the pain. ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management. The Company currently estimates that there are approximately two million people in the EU and the U.S. who could be candidates for ReActiv8.

ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability in the future. ReActiv8 has also been admitted to the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia, and has been approved for inclusion on the Protheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. In the U.S., ReActiv8 is FDA approved, and the Company plans to commercially launch in early 2021.

About Mainstay Medical Holdings

Mainstay Medical Holdings is a medical device company focused on commercializing an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.

About the ReActiv8-B Clinical Trial

Mainstay submitted the PMA application to the FDA based upon the totality of its clinical data for ReActiv8. The pivotal clinical trial upon which the PMA submission was based is the ReActiv8-B study. 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. Information about the study can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.

About Chronic Low Back Pain

One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to improve dynamic spine stability, allowing for improvement in CLBP and its disabling effects.

People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.

Further information can be found at www.mainstay-medical.com

Mainstay Medical Announces Reimbursement Approval for ReActiv8 in Australia

Mainstay Medical Holdings plc (“Mainstay” or the “Company”), today announced that ReActiv8, its implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, has been approved for inclusion in the Prostheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. This approval follows the December 2019 regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, which confirmed the inclusion of ReActiv8 in the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia.

Jason Hannon, CEO of Mainstay, said: “We continue to demonstrate the clinical value of ReActiv8 to patients suffering from Chronic Low Back Pain. Our growing body of evidence from clinical studies performed to date, as well as our early commercial experience in Germany, shows the substantial restorative benefits patients are receiving. We are delighted to be included in the Prostheses List, enabling us to deliver this valuable therapy to Australian physicians and patients. Several top Australian physicians have been part of our clinical studies since inception and are among the most experienced globally in selecting and treating patients with ReActiv8. We look forward to providing commercial availability of ReActiv8 to these physicians and their peers across Australia, which we intend to begin in early 2021.”

About ReActiv8

ReActiv8 is an active implantable medical device designed to treat people with chronic low back pain (CLBP). ReActiv8 electrically stimulates the nerves that supply the lumbar multifidus muscle, a key stabilizing muscle of the low back, to elicit contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.

Low back pain is the number one cause of years lived with disability worldwide and is a leading cause of activity limitation and work absence throughout much of the world, imposing a high economic burden on individuals, families, communities, industry, and governments. While treatment options exist for patients with CLBP of a predominantly neuropathic origin, for the large portion of patients whose pain is predominantly nociceptive (or mechanical) in nature there are few therapies beyond drugs and injections, both of which offer temporary relief at best. ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management. The Company estimates that there are approximately two million people in the EU and the U.S. alone who could be candidates for ReActiv8 today.

ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability in the future. The Company submitted the final module of its Pre-Market Approval (PMA) application to the U.S. FDA relating to ReActiv8 in August 2019, and it expects an approval decision around the end of 2020.

Inzomelid completes Phase I studies and shows positive results in the treatment of Cryopyrin-Associated Periodic Syndrome (CAPS)

• The Phase I study demonstrated Inzomelid has an excellent safety, tolerability and pharmacokinetic profile in healthy subjects, with dose-dependent target engagement

• Inzomelid also delivered positive preliminary results from a patient with Cryopyrin-Associated Periodic Syndrome (CAPS)

• Inzomelid is a potent, selective, brain-penetrant NLRP3 inflammasome inhibitor intended for treatment of debilitating inflammatory diseases of the brain and is expected to move into Phase II trials this year

Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces the successful completion of a Phase I study of Inzomelid, alongside positive results from a Cryopyrin-Associated Periodic Syndrome (CAPS) patient dosed with Inzomelid. CAPS is an autoinflammatory orphan disease driven by mutated NLRP3. The results support the progression of Inzomelid into Phase II clinical trials.

Inzomelid is a selective, orally available small molecule inhibitor of the NLRP3 inflammasome. Activation of the NLRP3 inflammasome is implicated in many diseases caused by chronic, harmful inflammation.

Drug exposures in the double blinded and randomised Phase I trial in healthy subjects increased linearly with dose, and correlated with markers of target engagement. The drug also demonstrated an excellent safety and tolerability profile.

Preliminary analysis from the CAPS part of this study showed that a patient with a confirmed NLRP3 mutation suffering from a CAPS-related flare showed rapid clinical improvement within hours and remission within days. A follow-on Phase II trial is planned to identify the best dose for CAPS patients.

Inzomelid follows Inflazome’s other NLRP3 inflammasome inhibitor, Somalix, in successfully completing Phase I trials. Somalix, an orally available, peripherally-restricted drug for inflammatory diseases, also demonstrated excellent safety, tolerability and pharmacokinetics in healthy subjects and is expected to enter Phase II trials in 2020.

Dr. Thomas Jung, Chief Medical Officer of Inflazome, commented, “The positive Phase I results from our two lead candidates, Inzomelid and Somalix, further validate our technology platform as we head with real momentum towards multiple Phase II trials later this year. The Inzomelid CAPS data also represents a very exciting step for the field in orphan indications. We believe this is the first example of positive data in a human disease setting with a small-molecule NLRP3 inhibitor. Our primary motivation is to develop drugs for which a high unmet medical need exists, so we are pleased to see that Inzomelid has demonstrated clear clinical potential.”

About Inflazome

Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH. Inflazome has two clinical-stage investigational drugs. Inzomelid is under development as an orally available, brain-penetrant drug and Somalix is under development as an orally available, peripherally-restricted drug. Both will address clinical unmet needs in inflammatory conditions. Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia. To learn more visit: inflazome.com

About the NLPR3 Inflammasome

Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.

About Cryopyrin-associated periodic syndromes

Cryopyrin-associated periodic syndromes (CAPS), also called cryopyrin-associated autoinflammatory syndromes, are three diseases related to a defect in the NLRP3 gene. CAPS encompasses neonatal onset multisystem inflammatory disease (NOMID), Muckle-Wells syndrome (MWS) and familial cold autoinflammatory syndrome (FCAS). The differences in these diseases lie in their severity and the organs involved.

Neuromod Appoints Florian Elsaesser as Chief Commercial Officer

Advances Commercialisation of Tinnitus Treatment Lenire™

Neuromod Devices Limited (“Neuromod” or “The Company”), the Irish medical technology company specialising in non-invasive neuromodulation technologies, is pleased to announce that Mr. Florian Elsaesser has been appointed as Chief Commercial Officer.

Mr. Elsaesser, a hearing aid industry expert, has worked in the sector for over 12 years in 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 holds a Master's degree in Economics from Technische Universität Berlin and graduated in Management from the renowned Ecole Supérieure de Commerce de Paris (ESCP).

Mr. Elsaesser's appointment follows the completion of two of the largest and longest followed up clinical trials ever conducted in tinnitus, including 517 participants. Mr. Elsaesser will be responsible for advancing the commercialisation of the Neuromod’s breakthrough tinnitus treatment product - Lenire™.

The Company is working towards the European commercialisation of Lenire®; scaling up manufacturing capacity to meet anticipated European demand; and progressing US regulatory strategy to secure market entry into the United States. Mr. Elsaesser will play a key role in these developments.

Welcoming the appointment, Dr. Ross O’Neill, CEO of Neuromod said: “I am delighted to announce that Florian Elsaesser will be joining the Neuromod team as Chief Commercial Officer. Attracting a leading hearing aid industry expert with extensive experience across the sector is an exciting development and recognition of the immense potential of our technology. It is a pivotal time for the Company as we progress with European commercialisation of Lenire™. Florian’s experience will be crucial as we work towards delivering our much-anticipated breakthrough treatment to people currently living with tinnitus.”

Mr. Elsaesser added: "With Lenire™ Neuromod has developed a fantastic treatment option for the millions of tinnitus sufferers globally whose clinical needs remain under served. Lenire™ has achieved compelling results in multiple large-scale clinical trials. Personally, I am excited about the high overlap between tinnitus and hearing impairment. For a huge number of patients, tinnitus is often a leading indicator of hearing loss. These patients tend to seek treatment for tinnitus much earlier than for hearing loss. Therefore I see huge opportunities for Lenire™ to boost the hearing aid retail market.”

Inflazome’s Somalix Demonstrates Positive Safety, Tolerability and Pharmacodynamic Profile in its Phase I Study

• Results from the first-in-human study showed excellent safety, tolerability and pharmacokinetics in healthy subjects resulting in target engagment at all doses tested. These results support the progression of Somalix into Phase II studies this year.

• Somalix is a potent and selective NLRP3 inflammasome inhibitor under development as an orally available, peripherally-restricted drug for inflammatory diseases.

Dublin (IE), Cambridge (UK), Brisbane (AU) | Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces the successful completion of a Phase I study of its investigational drug, Somalix. Somalix is a small molecule, peripherally-restricted inhibitor of the NLRP3 inflammasome. The Phase I data showed excellent safety and tolerability, while pharmacokinetics showed linear increase with dose which could be correlated with pharmacodynamic response. The results further validate Inflazome’s technology platform and support the progression of Somalix into Phase II clinical trials in the second quarter this year.

Activation of the NLRP3 inflammasome in the body is implicated in many diseases caused by chronic, uncontrolled inflammation. The Phase I study was a first-in-human, single-centre, double blinded and randomised trial that demonstrated excellent safety or tolerability in healthy, adult participants.

Subject to positive Phase I study results, Inflazome also intends to subsequently progress its second investigational drug, Inzomelid, into Phase II studies this year. Inzomelid is an orally available, brain-penetrant small molecule, intended for treatment of debilitating inflammatory diseases of the brain.

Thomas Jung, Chief Medical Officer of Inflazome, commented, “We are very pleased to have progressed our investigational drug, Somalix, through a first-in-human Phase I study and to have demonstrated safety, tolerability and pharmacodynamic response. We can now accelerate Somalix to fulfill its potential through multiple Phase II studies. We are expecting further data read outs for our investigational brain-penetrant drug Inzomelid very soon and look forward to progressing our pipeline to address inflammatory diseases with significant unmet medical need.”

About Inflazome

Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH. Inflazome has two clinical-stage investigational drugs. Inzomelid is under development as an orally available, brain-penetrant drug and Somalix is under development as an orally available, peripherally-restricted drug. Both will address clinical unmet needs in inflammatory conditions. Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia. To learn more visit: inflazome.com

About the NLPR3 Inflammasome

Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.

Inotrem expands Series B financing to €58 Million with a mix of Equity and Debt, adding new investors Fountain Healthcare Partners, Kreos and BPI France

• New investor Fountain Healthcare Partners provides a further €5 M capital increase adding on the initial €39 M announced last September

• Inotrem also secured a €13 M credit line from Kreos Capital and a €1 M loan from BPI France.

• Proceeds will be used to advance the Company’s applications in septic shock and chronic inflammatory diseases.

Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway with potential applications for acute and chronic inflammatory syndromes, announced a €5M capital increase financed by Fountain Healthcare Partners, a leading Irish venture capital firm with offices in Dublin and New York. This fundraising brings Inotrem’s Series B financing to a final closing amount of €44M. In addition, the Company secured a €13M credit line from Kreos Capital, Europe's largest provider of specialty finance to growth companies, and a €1M loan from BPI France, France’s public investment bank.

The financing will support Inotrem’s R&D effort, in particular of its lead drug candidate, nangibotide, which is currently undergoing a global multicentric Phase IIb trial in septic shock patients (ASTONISH trial) in 5 European countries and the United States, and of a companion diagnostic tool aimed at selecting those septic shock patients that are more likely to respond favorably to treatment. Financing will also allow the Company to expand its TREM-1 franchise to address chronic inflammatory diseases.

“With Fountain Healthcare Partners joining our pool of world-class investors, Inotrem is in an ideal position to advance its market-breaking technology platform centered on the TREM-1 pathway and bring new immunotherapies to patients and the medical community” said Jean-Jacques Garaud, CEO of Inotrem.

Based on a novel approach of immunomodulation which targets the TREM-1 pathway, Inotrem has developed a proprietary technology platform and leverages its extensive knowledge of the TREM-1 pathway biology to develop programs in several indications with inflammatory syndromes for which there is a major and today unsatisfied therapeutic need. Its lead compound, nangibotide, targets septic shock which is the ultimate complication of sepsis. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. There is currently no specific mechanism-based therapy approved for this indication. Inotrem’s solution has the potential to become the first mechanism-based treatment for septic shock.

“Inotrem has demonstrated its ability to reach several critical milestones and we are delighted to back this team. The TREM-1 pathway is extremely compelling and has great potential to bring solutions to patients that today lack effective therapies”, indicated Ena Prosser of Fountain Healthcare Partners.

In conjunction with the financing, Ena Prosser of Fountain Healthcare Partners will become a member of Inotrem’s Board of Directors, and Aris Contantinides of Kreos Capital will become an observer on Inotrem’s Board of Directors.

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. Inotrem is a FrenchTech120 company: it was chosen to join the program launched by the French President of the Republic and the Prime Minister to support the development of fast growing startups. For more information please visit: www.inotrem.com

About Fountain Healthcare Partners

Fountain Healthcare Partners is a life science venture capital fund with offices in Dublin, and New York. Founded in 2008, Fountain is Ireland’s largest dedicated life science venture capital fund with more than €294 million under management. Fountain invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit and a defined pathway to commercialisation, value enhancement and exit. Fountain typically leads or co-leads its investments and has sourced private and public deals from start-ups, corporate spin-outs and turnaround situations. The Fountain Healthcare Partners team brings to investees over 70 years of collective experience in the pharmaceutical industry, corporate venture capital and VC across multiple investment and market cycles. For more information please visit: www.fh-partners.com

About Kreos Capital

Kreos Capital is the leading provider of growth-debt financing to high-growth companies in Europe and Israel with revenues up to EUR 300 million. Since 1998, as the pioneer growth debt provider across Europe and Israel, Kreos has completed 540 transactions and committed more than EUR 2.3 billion in 16 different countries. Kreos is dedicated to supporting management teams and their equity investors with flexible loan structures for all stages of a growth company's development and to address the needs for growth capital, working capital, acquisition financings, lower mid-market buy-outs, roll-up strategies, banks re-financings as well as pre- and post-IPO financings. Kreos's most recent fund, EUR 700 million Kreos VI, was launched in January 2019. The Kreos global team has extensive debt financing, management and equity investing experience, covering the markets in Europe and Israel from its locations in London, Tel-Aviv and Stockholm.

Media contact for Inotrem

Anne REIN S&I | STRATEGIES&IMAGE

anne.rein@strategiesimage.com

+33 6 03 35 92 05

Inflazome IP Portfolio Strengthened with Patents Granted in US and Europe

• USPTO and EPO grant patents licensed exclusively to Inflazome

• Patent claims cover Inflazome’s brain penetrant drug Inzomelid

DUBLIN, Ireland, CAMBRIDGE, United Kingdom & BRISBANE, Australia - Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple small molecule drugs that block harmful inflammation, today announces that the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO) will grant the patent application WO 2016/131098 as US 10,538,487 on 21 January 2020 and EP 3,259,253 on 15 January 2020.

The patents provide for compounds which have advantageous properties and show useful activity in the inhibition of NLRP3 inflammasome activation. Such compounds are useful in the treatment of a wide range of disorders, including Parkinson’s, Alzheimer’s and Motor Neuron Disease, in which inflammation arising from the NLRP3 inflammasome is implicated as a key factor. Inflazome currently has two ongoing Phase I studies with Inzomelid and Somalix.

These new patents strengthen Inflazome’s intellectual property portfolio that extends to 43 patent families, reinforcing the company’s leading innovative position in discovering targeted therapies for inflammatory-driven diseases.

Matt Cooper, Chief Executive Officer of Inflazome, commented: “The granting of these pioneering patents marks another milestone for Inflazome and strengthens our IP portfolio. The patents granted in the US and Europe cover our lead clinical candidate, Inzomelid. Both Inzomelid and our second drug, Somalix, are in the final stages of Phase I safety and tolerability trials for inflammatory diseases. We look forward to driving these drugs into further trials to help people with debilitating diseases.”

The patent was originally filed by the University of Queensland and Trinity College Dublin following a highly productive collaboration between Inflazome founders, Professor Matt Cooper (University of Queensland) and Professor Luke O’Neill (Trinity College Dublin). It was licensed exclusively to Inflazome when the company was founded.

About Inflazome

Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH. Inflazome has two ongoing Phase I studies, the first with Inzomelid which is under development as an orally available, brain-penetrant drug, and the second with Somalix which is under development as an orally available, peripherally-restricted drug to address clinical unmet needs in inflammatory conditions. Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia. To learn more visit: inflazome.com

About the NLPR3 Inflammasome

Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.

Contacts

Inflazome: Dr Jeremy Skillington | VP Business Development E: j.skillington@inflazome.com
Media: FTI Consulting: UK & International | Ciara Martin/Tim Stamper T: +44 20 37271000 Ireland & International | Jonathan Neilan/Patrick Berkery T: +353 1 7650800 E: StratCommEMEAInflazome@fticonsulting.com

KaNDy Therapeutics Announces Positive Phase 2b Data in Post-Menopausal Women with its Lead Non-Hormonal Product NT-814

• Phase 2b dose range finding study showed rapid and highly significant reductions in the frequency of hot flashes (primary endpoint) for the full 12-week treatment period

• Reduction in hot flashes was associated with statistically significant improvements in quality of life, mood and sleep – all key secondary endpoints

• All doses of NT-814 were well tolerated during the study, demonstrating a safety profile that supports progression to Phase 3 ~

Stevenage, UK – KaNDy Therapeutics, a UK clinical-stage biotech company, today announces positive data from the Phase 2b “SWITCH-1” clinical trial with its lead non-hormonal drug candidate, NT-814, for the treatment of symptoms of the menopause.

Following on from the clear benefits NT-814 demonstrated in the Phase 2a RELENT-1 study, the SWITCH-1 trial provides further compelling evidence that NT-814, a first in class, once-daily, oral neurokinin-1,3 receptor antagonist, can produce a rapid and marked reduction in the most troublesome and frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The clinical relevance of the marked improvements shown on the vasomotor symptom endpoints was supported by highly statistically significant improvements across patient reported assessments of quality of life, mood and sleep.

The SWITCH-1 study was a randomised, double-blind, placebo-controlled trial conducted in the US, UK and Canada. One hundred and ninety-nine women experiencing at least 7 moderate or severe hot flashes/flushes (HF) per day were recruited into the study and randomised to receive one of four doses of NT-814 or placebo. Treatment with NT-814 once daily for 12 weeks at the most effective dose evaluated resulted in:

• Statistically significant reductions compared to placebo in average hot flash frequency (primary endpoint), starting during the first week of treatment and continuing throughout the 12-week treatment period. Least squares mean reductions in average hot flash frequency were -6.7 for NT-814 vs -2.7 for placebo at week 4, and -7.8 vs -4.7 at Week 12 (p<0.0001 and p=0.0092, respectively).

• Marked improvements in all key secondary endpoints: improved quality of life was shown by highly significant improvements over placebo in the MenQoL menopause-specific quality of life scores, benefits on mood were demonstrated by significant improvements in the Beck Depression Inventory (II), and improved quality of sleep was shown by statistically significant improvements compared to placebo in the Pittsburgh Sleep Quality Index scores.

• NT-814 was well tolerated across the dose range with a safety profile that supports progression to Phase 3.

Dr. James A. Simon, Clinical Professor of Reproductive Endocrinology & Infertility at George Washington University, and the study’s Lead Investigator, commented: “These top-line results of the SWITCH-1 study are very exciting. They demonstrate that NT-814, a truly novel therapy, offers a rapidly effective, non-hormonal approach to treating menopausal hot flashes and night sweats, debilitating symptoms of menopause. Unique to this trial, patients also reported improvements in quality of life, mood and sleep with NT-814.”

Dr Mary Kerr, Co-Founder and CEO KaNDy Therapeutics, said: “The SWITCH-1 study started in November 2018, and so we are excited to share such positive results on schedule. The data confirms and validates Phase 2a observations, providing more evidence that neurokinins are fundamental to sex hormone biology and the pathophysiology of the menopause, resulting in almost immediate symptom relief. The Company looks forward to presenting these data at future scientific meetings and discussing it with regulatory agencies in advance of progressing the compound into pivotal registration studies.”

For more information, please contact:

KaNDy Therapeutics
Email: info@kandytherapeutics.com
Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDyTherapeutics@consilium-comms.com

About the SWITCH-1 Study:
The Phase 2b SWITCH-1 study was a randomised, double-blind, placebo-controlled study conducted at 25 sites in the UK, US and Canada. It included an adaptive randomisation design that enabled the randomisation ratio to be modified to focus on doses of greatest interest based on emerging data. The study was initiated in November 2018 and completed, ahead of schedule, at the end of 2019. A total of 199 post-menopausal women experiencing at least 7 moderate or severe HFs per week were recruited into the study and randomized to receive one of four doses of NT-814 or placebo. Study drug was taken once daily in the evening for 12 weeks. Subjects completed electronic diaries twice daily for the two weeks before and throughout treatment and underwent routine safety assessments periodically throughout the trial. Patient reported assessments of sleep, quality of life and mood were also completed periodically during study visits. Further information on the study design can be found on www.clinicaltrials.gov and full results of the study will be published at scientific congresses and in peer-reviewed journals over the coming months.

NT-814 is an orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses vasomotor symptoms by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of hot flashes and night sweats.

KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal vasomotor symptoms, are debilitating for women often over many years and associated with significant healthcare and economic costs. NT-814 is wholly owned by KaNDy.

Syndesi Therapeutics announces the expansion of its management team with the appointment of Torsten Madsen, MD, PhD as Chief Medical Officer

Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, today announced Torsten Madsen MD, PhD has joined its management team as Chief Medical Officer.

Dr. Madsen brings over 12 years’ industry experience in CNS drug development in pharma/biotech. As a senior leader at Lundbeck in Denmark and the US he guided clinical development and registration of the anti-depressant vortioxetine. More recently, he has held senior roles at the CNS focused biotech companies Naurex and Aptinyx. Dr. Madsen earned his MD and a PhD from Copenhagen University, doing clinical training in psychiatry and general medicine and holding a postdoc position at Yale, conducting basic research in neural and synaptic plasticity.

Commenting on the appointment, Jonathan Savidge, CEO of Syndesi, said, “I’m delighted to welcome Torsten to the Syndesi team at an exciting time for the development of our lead molecule SDI-118. Torsten brings a wealth of experience specifically in CNS drug development and this will be invaluable to the company as we plan the next phases of clinical development for SDI-118.”

On his appointment as CMO, Torsten Madsen said, “It’s very exciting to be joining Syndesi to work on a novel synaptic mechanism with potential for broad applicability for treatment of cognitive impairment. I look forward to working with the Syndesi management team to progress SDI-118 into the next stage of clinical development to fully explore its potential to improve symptoms of cognitive impairment across a range of indications.”

About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. Syndesi is investigating the potential of these molecules to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well other conditions such as major depression and cognitive impairment associated with schizophrenia. The lead molecule, SDI-118, has successfully completed a First-in-Human Phase I study which demonstrated target engagement with PET imaging. The company has raised a total €17M in Series A funding from a syndicate of Belgium and international investors and has been awarded a total of up to €3.2 M in non-dilutive funding from the Walloon Region to support the development of the lead molecule SDI-118. For more information please visit www.syndesitherapeutics.com.

Mainstay Medical Announces Completion of Day 100 Meeting with FDA Regarding Pre-Market Approval (PMA) Application for ReActiv8

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Growth operated by Euronext Dublin (MSTY.IE), a medical device company focused on bringing to market ReActiv8, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, today announced that on 10 December 2019 the Company completed a Day 100 meeting with the U.S. Food and Drug Administration (FDA) regarding a Pre-Market Approval (PMA) application submission for ReActiv8.

Jason Hannon, CEO of Mainstay, said: “We appreciate the opportunity to meet with FDA to discuss their review of the data we included in the PMA. The productive dialogue will help us submit an amendment to the PMA to reflect FDA’s feedback. We continue to expect a decision regarding approval around the end of 2020.”

FDA generally meets with the PMA sponsor approximately 100 days after filing of the PMA for the purpose of discussing the status of the review of the application. Prior to the meeting, FDA provided Mainstay with its initial feedback on the PMA, consisting of questions regarding the data included in the PMA and the interpretation of such data. The Company currently has no plans to conduct another premarket pivotal IDE trial for ReActiv8.

Mainstay will include the information requested by FDA in an amendment to the PMA, which the Company expects to file in the first quarter of 2020.

Mainstay Medical Announces Regulatory Approval from Australian Therapeutic Goods Administration (TGA) for ReActiv8

Application for inclusion on Australian Prostheses List for private reimbursement planned for first quarter of 2020, with an approval decision expected in the third quarter of 2020.

Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Growth operated by Euronext Dublin (MSTY.IE), today announced that it has received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, its implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain. This approval confirms admission of ReActiv8 to the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia.

Jason Hannon, CEO of Mainstay, said: “We are excited to receive TGA approval and take the next step toward making ReActiv8 available to patients in Australia. Australian physicians who have been part of our clinical studies to date are among the most experienced globally in selecting and treating patients with ReActiv8 therapy. The clinical data in support of ReActiv8 continues to build and was instrumental in demonstrating to TGA that ReActiv8 is a valuable therapy that should be available to Australian patients. This approval was received ahead of our expected timeline, and we will now move to the next step in the process, which is applying for inclusion of Reactiv8 on the Prostheses List. We plan to launch ReActiv8 commercially after securing a place on the Prostheses List.”

The Company plans to submit an application for ReActiv8 to be included in the Prostheses List of reimbursed products, with a reimbursement decision expected in the third quarter of 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia.

About ReActiv8

ReActiv8 is an active implantable medical device designed to treat people with chronic low back pain (CLBP). ReActiv8 electrically stimulates the nerves that supply the lumbar multifidus muscle, a key stabilizing muscle of the low back, to elicit contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.

Low back pain is the number one cause of years lived with disability worldwide and is a leading cause of activity limitation and work absence throughout much of the world, imposing a high economic burden on individuals, families, communities, industry, and governments. While treatment options exist for patients with CLBP of a predominantly neuropathic origin, for the large portion of patients whose pain is predmoniantly nociceptive (or mechanical) in nature there are few therapies beyond drugs and injections, both of which offer temporary relief at best.

ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management. The Company estimates that there are approximately two million people in the EU and the U.S. alone who could be candidates for ReActiv8 today.

ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability in the future. The Company submitted the final module of its Pre-Market Approval (PMA) application to the U.S. FDA relating to ReActiv8 in August 2019, and it expects an approval decision around the end of 2020.

Inflazome Progresses Two Drugs Into Clinical Trials

• Two Phase I studies are underway for Inzomelid and Somalix, Inflazome’s NLRP3 inflammasome inhibitors, with data due in Q1 2020

• Inzomelid is under development as an orally available, brain-penetrant drug for neuroinflammatory diseases such as Parkinson’s, Alzheimer’s and Motor Neuron Disease as well as orphan diseases such as CAPS (Cryopyrin-associated periodic syndromes)

• Somalix is under development as an orally available, peripherally-restricted drug to address clinical unmet needs in inflammatory conditions such as arthritis and cardiovascular disease

Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces that healthy volunteers have been successfully dosed in the company’s Phase I clinical trials of Inzomelid and Somalix, two small molecule inhibitors of the NLRP3 inflammasome. These trials represent an important milestone for Inflazome and confirm its leadership in the inflammasome space.

Activation of the NLRP3 inflammasome in the body drives harmful inflammation, and is implicated in many diseases. Inzomelid and Somalix are two potent small molecules designed to inhibit activation of NLRP3 and reduce the damage caused by chronic, uncontrolled inflammation.

Inzomelid is a brain-penetrant drug intended for the treatment of neuroinflammatory and neurodegenerative diseases such as Parkinson’s, Alzheimer’s and Motor Neuron Disease as well as the orphan disease CAPS.

Somalix is intended for the treatment of debilitating conditions such as cardiovascular disease, arthritis and many other diseases.

Both Phase I studies are first in human, single-centre, double blinded, randomised trials and are designed to evaluate safety and tolerability in healthy adult participants. The Inzomelid trial is expected to complete in January 2020, whilst Somalix will complete in March 2020. The Company intends to progress Inzomelid and Somalix into multiple Phase II studies in 2020.

Thomas Jung, Chief Medical Officer of Inflazome, commented, “We are delighted to see our two leading candidates, Inzomelid and Somalix, progress into the clinic and take a step closer towards finding a treatment for patients suffering from a range of diseases caused by harmful inflammation.”

Matt Cooper, Chief Executive Officer of Inflazome, commented, “This achievement represents an important milestone for Inflazome and for the field of inflammatory diseases more generally. We are excited to advance two drugs into safety trials in preparation for multiple proof of concept Phase II trials in 2020. We have pioneered the development of inhibitors of inflammasome-driven inflammation and will use our expertise to bring benefits to patients as quickly as possible.”

About Inflazome

Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH. Inflazome has two ongoing Phase I studies, the first with Inzomelid is under development as an orally available, brain-penetrant drug for neuroinflammatory diseases such as Alzheimer’s, Parkinson’s and Motor Neuron Disease. Somalix is under development as an orally available, peripherally-restricted drug to address clinical unmet needs in inflammatory conditions such as arthritis and cardiovascular disease. Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia.

To learn more visit: inflazome.com

About the NLPR3 Inflammasome

Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.

Contacts

Inflazome: Dr Jeremy Skillington | VP Business Development

E: j.skillington@inflazome.com

Media: FTI Consulting

UK & International | Ciara Martin/Tim Stamper

T: +44 20 37271000

Ireland & International | Jonathan Neilan/Patrick Berkery

T: +353 1 7650800

E: StratCommEMEAInflazome@fticonsulting.com