Corteria Pharmaceuticals initiates Phase 2 trial in heart failure and Phase 1 trial in obesity with its first-in-class CRF2 agonists

• CRAFT-WHF Phase 2 trial of COR-1167 initiated in patients with worsening heart failure

• Phase 1 trial of COR-1389 ongoing in subjects with obesity

Corteria Pharmaceuticals, a clinical-stage biopharmaceutical company focused on the development of transformative therapies for heart failure and obesity, today announces the clinical advancement of its two first-in-class corticotropin‑releasing factor receptor 2 (CRF2) agonists, COR‑1167 and COR‑1389.

CRAFT-WHF Phase 2 trial of COR-1167 in worsening heart failure

COR-1167 is a once‑daily, subcutaneous CRF2 peptide agonist being developed for the treatment of worsening heart failure (WHF). In a randomized, placebo‑controlled Phase 1 trial, COR‑1167 was generally safe and well tolerated in healthy volunteers and patients with chronic heart failure. A single dose administered to patients demonstrated clear CRF2 target engagement based on improvement in a variety of cardiac function parameters, with no adverse impact on blood pressure.

Following the positive Phase 1 trial results, Corteria has initiated the CRAFT-WHF Phase 2 randomized, double-blind, placebo-controlled trial in patients with WHF (NCT06815471/EU CT 2024-518951-52). It will enroll a targeted 300 patients to assess the safety and cardiorenal effects of three different doses of COR-1167 administered for one month. Topline results are expected by the end of 2026.

Phase 1 trial of COR-1389 in obesity

COR-1389 is a long-acting once-weekly subcutaneous CRF2 peptide agonist being developed for the treatment of obesity with associated heart failure and right-sided heart failure due to pulmonary hypertension (Group 2).

A Phase 1 randomized, placebo‑controlled, trial of COR-1389 is ongoing (EU CT 2024-514853-31). The single ascending dose (SAD) phase investigating the safety, tolerability and pharmacokinetics in healthy volunteers has been completed and a 12-week multiple ascending dose (MAD) phase is now underway to assess the safety and efficacy of COR-1389 in subjects with obesity, including the evaluation of its effects on weight and body composition by whole-body MRI. Topline results are expected in the second half of 2026.

In a mouse model of diet induced obesity (DIO), COR-1389 showed substantial metabolic benefits associated with an increase in energy expenditure. It drove weight loss comparable to GLP1 agonists, while reducing fat mass and increasing lean (muscle) mass. When co-administered with tirzepatide or semaglutide, COR-1389 demonstrated additive benefits on fat loss while preventing the lean mass loss observed with these agents.

COR-1389 has also shown cardiopulmonary benefits in animal models of right-sided heart failure, improving cardiopulmonary hemodynamics and reversing maladaptive right ventricular and pulmonary artery remodeling. A Phase 1b trial is being planned to evaluate acute hemodynamic responses in patients with group 2 pulmonary hypertension, with topline results expected in the second half of 2026.

“Advancing both COR‑1167 and COR‑1389 in the clinic underscores our commitment to delivering first‑in‑class CRF2‑targeted therapies for patients with limited treatment options,” said Philip Janiak, founder and CEO of Corteria Pharmaceuticals. “The robust preclinical data, together with the emerging clinical data, strengthen our confidence as we move into Phase 2 and expand our footprint in cardiometabolic diseases.”

About Worsening Heart Failure

Chronic heart failure afflicts more than 60 million people worldwide. It is characterized by periods of clinical stability being frequently interrupted by episodes of worsening symptoms and signs, defined as worsening heart failure (WHF). Episodes of WHF impact more than 20% of heart failure patients and are among the most common causes for hospitalization, accelerating the progression of disease and resulting in substantial risk of morbidity and mortality. Given the central role of congestion in WHF, loop diuretics are the standard of care treatment. However, while effective acutely, these do not improve rehospitalization rates or patient outcomes. Therefore, WHF remains a critically important unmet medical need that continues to have a major impact on quality of life and imposes a major economic burden on the global healthcare system.

About Obesity with Associated Heart Failure

Obesity impacts more than one billion people worldwide and is a causal factor in heart failure and other serious health complications such as Type 2 diabetes, obstructive sleep apnea and sarcopenia. Implementing diet and exercise regimens are the first line of treatment, but this approach is frequently inadequate and can be accompanied by metabolic readjustment resulting in eventual regain of excess weight. The most effective currently available drug therapies for weight loss are GLP-1 and GLP-1/GIP peptides, but in many cases these drugs are associated with side effects such as bloating, nausea, and vomiting, leading to challenges with adherence and maintenance of weight loss. These therapies also often result in substantial loss of muscle mass, which can negatively impact patient health. Therefore, obesity remains a global health crisis and novel therapies are urgently needed that target fat loss with preserved lean mass, while also directly ameliorating comorbidities such as obesity-associated heart failure, which affects an estimated 30 million people worldwide.

About Right-Sided Heart Failure

Right-sided heart failure (RHF) is typically caused by pulmonary hypertension (PH) often associated with left-sided heart disease and afflicts approximately 10 million people worldwide. It is a fatal disease with no approved therapies and involves the development of right ventricular dysfunction (RVD) that leads to a progressive deterioration in exercise capacity and quality of life, and ultimately to a high risk of cardiovascular mortality. Despite therapeutic advances for left-sided heart disease, there are no therapies which specifically aim at improving RVD. Pulmonary vasodilators such as endothelin receptor antagonists, PDE-5 inhibitors and prostacyclin analogs are approved for pulmonary arterial hypertension, another smaller subgroup of PH, but these drugs have not been shown to be effective in the more common form of PH resulting from left-sided heart disease (classified as Group 2). The standard of care remains limited to diuretics for relieving symptoms of congestion. Therefore, novel therapies are urgently needed for the treatment of RHF due to Group 2 PH.

About Corteria Pharmaceuticals

Corteria is a privately held, clinical-stage biopharmaceutical company developing first-in-class medicines for the treatment of heart failure and obesity. The company is advancing a daily CRF2 peptide agonist, COR-1167, for the sub-chronic treatment of worsening heart failure; a long-acting once-weekly CRF2 peptide agonist, COR-1389, for the chronic treatment of obesity-associated heart failure and right-sided heart failure; and an arginine vasopressin neutralizing monoclonal antibody, COR-2007, for the treatment of acute heart failure with hyponatremia and autosomal dominant polycystic kidney disease.
www.corteriapharma.com

Contact

Stéphane Durant des Aulnois, CFO
Corteria Pharmaceuticals
stephane.durant_des_aulnois@corteriapharma.com

Andrew Lloyd & Associates
Juliette Schmitt / Saffiyah Khalique
juliette@ala.associates / saffiyah@ala.associates
UK: +44 1273 952 481
US: +1 203 724 5950

Corteria Pharmaceuticals announces initiation of Phase 1 study to evaluate CRF2 agonist COR-1167 for treatment of worsening heart failure

Corteria Pharmaceuticals (‘Corteria’), a clinical-stage biopharmaceutical company focused on the development of transformative therapies for heart failure and obesity, today announces the initiation of its Phase 1 study to evaluate the company’s first-in-class corticotropin-releasing hormone receptor 2 (CRF2) agonist, COR-1167, for the treatment of Worsening Heart Failure (WHF).

COR-1167 is a once-daily subcutaneous CRF2 agonist that has demonstrated substantial protective effects and functional improvement in the heart, vasculature and kidneys in multiple animal models of heart failure. Its unique mechanism of action offers a novel opportunity for treating WHF with the goal of alleviating cardiac congestion by restoring and maintaining stable cardiovascular and renal function.

The Phase 1 trial is a randomized placebo-controlled study with the primary objective of assessing the safety and tolerability of COR-1167 in both healthy volunteers and patients with chronic heart failure.

“The advancement of our lead CRF2 agonist into the clinic is a significant milestone in our mission to bring novel treatments to patients experiencing the debilitating effects of worsening heart failure,” said Philip Janiak, founder and CEO of Corteria Pharmaceuticals. “The preclinical data for COR-1167 is very promising and we are excited to determine its therapeutic potential in patients.”

Prof. Adriaan Voors, professor of cardiology at the University Medical Centre Groningen (Netherlands) and principal investigator of the study, emphasized that: “the initiation of this Phase 1 study with COR-1167, a CRF2 agonist, both in healthy volunteers and patients with heart failure is an important step in potentially reducing the burden of heart failure, especially for patients who experience worsening signs and symptoms despite being treated with currently recommended therapies.”

The company anticipates completing the Phase 1 study in the first half of 2025, to be followed by the initiation of a Phase 2 study in this indication.

About Worsening Heart Failure

The clinical course of heart failure is characterized by periods of clinical stability being frequently interrupted by episodes of worsening symptoms and signs, defined as Worsening Heart Failure (WHF). Given the central role of congestion in WHF, loop diuretics are the standard of care treatment. However, while effective acutely, these do not improve rehospitalization rates or patient outcomes. Therefore, WHF remains a critically important unmet medical need that continues to have a major impact on quality of life and imposes a major economic burden on the global healthcare system.

About Corteria Pharmaceuticals

Corteria Pharmaceuticals is a clinical-stage biopharmaceutical company developing first-in-class medicines for the treatment of heart failure and obesity. In addition to its lead daily CRF2 agonist, COR-1167, the company is advancing a long-acting CRF2 agonist for the chronic treatment of right heart failure and obesity, as well as an Arginine VasoPressin (AVP) neutralizing monoclonal antibody for the treatment of acute heart failure with hyponatremia. Worldwide, more than 60 million people live with heart failure and more than one billion with obesity, resulting in substantial morbidity and mortality.

Corteria Pharmaceuticals appoints Mark Pruzanski as Chairman of its Board of Directors

Corteria Pharmaceuticals (“Corteria”), a biopharmaceutical company specialized in the development of transformative therapies for heart failure and obesity, today announced it has appointed Mark Pruzanski, MD, as Chairman of its Board of Directors. He replaces Thierry Laugel, Managing Partner at Kurma Partners, who remains a member of the Board.

Dr. Pruzanski has more than 30 years of experience as a life sciences executive, entrepreneur and investor. He most recently served as Chairman and CEO of Versanis Bio, a private clinical-stage biopharmaceutical company focused on the development of new medicines for the treatment of obesity and other cardiometabolic diseases, which was acquired by Eli Lilly in July 2023. He founded Intercept Pharmaceuticals and was the company’s CEO until 2021, having led its evolution from drug discovery stage to a global development and commercial organization with a focus on addressing chronic liver diseases. He serves as a Board member of several private and public biotechnology companies, the Emerging Companies Section of the Biotechnology Innovation Organization (BIO), and the Foundation for Defense of Democracies, a non-profit policy institute focusing on foreign policy and national security.

Dr. Pruzanski received his M.D. from McMaster University in Hamilton, Canada, a M.A. degree in International Affairs from the Johns Hopkins University School of Advanced International Studies in Bologna, Italy and Washington, D.C., and a bachelor’s degree in Political Science from McGill University in Montreal, Canada.

“We are thrilled to welcome Mark as the Chairman of the Board of Directors,” said Philip Janiak, founder and CEO of Corteria Pharmaceuticals. “Mark brings extensive expertise in drug development with a solid track record in the biotechnology industry. His strategic vision, outstanding leadership and passion for innovation make him a valuable addition to Corteria as we continue our mission to advance innovative therapeutic solutions for heart failure and obesity.”

“It’s a privilege to join the Board of Corteria,” said Mark Pruzanski. “This is an exciting time in the company’s evolution as it brings its exciting first-in-class assets into the clinic and on the heels of its recent Series A financing led by top tier biotech investors. I am looking forward to working with Philip and the rest of the Board to help ensure Corteria’s future success.”

About Corteria Pharmaceuticals

Founded in 2021, Corteria is a privately held biopharmaceutical company developing first-in-class drugs with an initial focus on the treatment of heart failure. Despite improvements in the management of this serious disease, the prevalence of heart failure keeps increasing with more than 60 million patients worldwide and there are large subpopulations of patients who are poorly served by currently available treatments.

More information available at: www.corteriapharma.com

Investors/media contacts

Stéphane Durant des Aulnois, CFO
Corteria Pharmaceuticals
stephane.durant_des_aulnois@corteriapharma.com

Andrew Lloyd & Associates
Juliette Schmitt / Celine Gonzalez
juliette@ala.associates / celine@ala.associates
UK: +44 1273 952 481
US: +1 203 724 595

Corteria Pharmaceuticals Announces a €65M Financing to Advance Transformational Medicines in Cardiovascular Diseases

Corteria Pharmaceuticals (“Corteria”), a biopharmaceutical company specialized in the development of transformative therapies for unaddressed heart failure subpopulations, today announced an oversubscribed €65M ($71M) Series A co-led by US investment firm OrbiMed and EU-based leading investment firm Jeito Capital, with the participation of all existing seed investors (Kurma Partners, Fountain Healthcare Partners, V-Bio Ventures, Invivo Capital, Omnes Capital). As a result, Erez Chimovits from OrbiMed and Andreas Wallnoefer from Jeito Capital will join the board of Directors of Corteria.

The funding will be used to advance Corteria’s cardiovascular pipeline into the clinic.

Heart failure is a serious disease with a prevalence of more than 60 million patients globally and still growing. Corteria’s innovative approach is centered on selecting therapeutic targets involved in the worsening and acute forms of human heart failure, as well as a stratification strategy to identify specific subgroups that are most likely to benefit from the treatments. These forms of heart failure are widespread, life-threatening, and not directly addressed by the current standards of care.

Corteria was founded in 2021 by Sanofi’s former head of cardiovascular research, Philip Janiak, and Marie-Laure Ozoux, former cardiovascular project leader at Sanofi, around two cardiovascular programs in-licensed from Sanofi.

Since then, Corteria’s pipeline has expanded rapidly and comprises today three first-in-class therapies that are highly differentiated as they produce multi-organ benefits, acting on the kidneys, the heart, and the vessels:

• A once daily subcutaneous Corticotropin-releasing hormone receptor 2 (“CRF2”) agonist for the treatment of Worsening Heart Failure

• A once monthly subcutaneous CRF2 agonist for the treatment of Right Heart Failure

• An AVP (arginine vasopressin) neutralizing monoclonal antibody for the treatment of Acute Heart Failure with Hyponatremia

The lead asset for Worsening Heart Failure is expected to enter the clinic in early 2024.

“This financing marks a major milestone in our mission to bring therapies to heart failure subpopulations with high unmet needs,” said Philip Janiak, Founder and President of Corteria Pharmaceuticals. “We are extremely grateful to Jeito and OrbiMed as our new investors for their trust in our science and team and to our existing investors for their support and commitment since inception. We are looking forward to working all together to develop next generation transformative therapeutics.”

Andreas Wallnoefer, Partner at Jeito Capital, said: “Despite current treatments, heart failure is a progressing disease that impacts severely the lives of many patients and remains one of the leading causes of mortality worldwide. Corteria focuses on translating important therapeutic innovation in cardiology into clinical practice. Our investment in Corteria reflects Jeito’s commitment to address significant unmet needs in the realm of cardiology. We are excited to join forces with Corteria’s dedicated team to develop a portfolio of medicines with important clinical benefit for patients.”

“We are proud to have been involved with Corteria since its early days and impressed with the progress made to date. The company is now at a turning point of entering the clinic with its lead asset early next year and validating its unique positioning in well-defined heart failure subpopulations with high unmet medical needs. Kurma Partners is pleased to continue supporting the company during this key step that we hope will bring transformative clinical outcome for patients,” said Thierry Laugel, Managing Partner at Kurma Partners, and Chairman of the board of Corteria.

About OrbiMed

OrbiMed is a healthcare investment firm, with over $17 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed’s team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya, and other key global markets. www.orbimed.com

About Jeito Capital

Jeito Capital is a global leading Private Equity company with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking medical innovation. Jeito empowers and supports managers through its expert, integrated, multi-talented team and through the investment of significant capital to ensure the growth of companies, building market leaders in their respective therapeutic areas with accelerated patients’ access globally, especially in Europe and the United States. Jeito Capital has €534 million under management and a rapidly growing portfolio of investments. Jeito Capital is based in Paris with a presence in Europe and the United States. For more information, please visit www.jeito.life or follow @Jeito_life on Twitter or LinkedIn.

About Corteria Pharmaceuticals

Founded in 2021, Corteria Pharmaceuticals is a privately held biopharmaceutical company developing first-in-class drugs in heart failure subpopulations. Despite some improvements in the management of this serious disease, the prevalence of heart failure keeps increasing with more than 60 million patients worldwide. Corteria’s strategy involves innovative patient stratification and target selection based on human evidence and a better understanding of disease biology in patients with a focus on worsening and acute heart failure and right heart failure. More information available at: www.corteriapharma.com

Investors/media contacts

Stéphane Durant des Aulnois, CFO
Corteria Pharmaceuticals
stephane.durant_des_aulnois@corteriapharma.com

Andrew Lloyd & Associates
Saffiyah Khalique / Celine Gonzalez
saffiyah@ala.associates / celine@ala.associates
UK: +44 1273 952 481
US: +1 203 724 595

Corteria Pharmaceuticals strengthens its Executive Leadership Team, Board of Directors, and Scientific Advisory Board

Corteria Pharmaceuticals, a biotechnology company developing innovative treatments for certain forms of heart failure, announced today the recruitment of Dr. Francesca C. Lawson as Chief Medical Officer. Corteria Pharmaceuticals also expanded its Board of Directors with the addition of Dr. Marc Semigran as an independent Director, as well as its Scientific Advisory Board with the addition of Dr. Jeffrey Testani.

"We are highly pleased to welcome Drs. Lawson, Semigran and Testani to our team to accelerate the development of our programs. Their expertise and in-depth knowledge of these diseases will be invaluable to Corteria," commented Philip Janiak, founder and CEO of Corteria Pharmaceuticals.

Francesca C. Lawson, M.D., based in Philadelphia, USA, is a specialist in cardiometabolic diseases with more than 30 years of experience in drug development, from Phase 1 to Phase 3. Dr. Lawson joins Corteria Pharmaceuticals from Applied Therapeutics, where she spent three years overseeing the development of new drug candidates for the treatment of diabetic cardiomyopathy as Vice President, Clinical and Regulatory Strategy. Prior to Applied Therapeutics, she led the clinical trials of cardiometabolic drug candidates at Sanofi where she successfully developed sotaglifozin in worsening heart failure.

Marc Semigran, M.D., a cardiologist with subspecialty in heart failure based in Cambridge, USA, joins the Board of Directors of Corteria Pharmaceuticals as an independent Director. Dr. Semigran currently serves as Chief Medical Officer at Renovacor, and previously as Head of Clinical Development of MyoKardia, a biopharmaceutical company pioneering new approaches for the treatment of cardiomyopathies. There, he led the development of mavacamten in hypertrophic cardiomyopathy. Dr. Semigran is the author of numerous scientific peer-reviewed publications, for which he has received several prestigious awards. While Medical Director of the Heart Failure and Cardiac Transplant Program at Massachusetts General Hospital and Harvard Medical School, he served as principal investigator in major clinical trials.

Jeffrey Testani, M.D., a cardiologist, associate professor of Medicine and Director of Heart Failure Research at Yale University, USA, is an expert on heart failure and cardiac transplantation. Dr. Testani also runs a large research program focusing on cardio-renal syndrome at the Yale Heart and Vascular Center and has published several seminal papers in peer-reviewed journals.

About Corteria Pharmaceuticals:

Founded in 2021 and based in Paris, France, Corteria Pharmaceuticals is a biotechnology company specialized in the development of first-in-class drugs for the treatment of heart failure subpopulations. Despite advances in the management of this serious disease, the prevalence of heart failure continues to rise, with over 60 million cases worldwide. Corteria Pharmaceuticals' innovative approach is based on a selection of therapeutic targets involved in the worsening of heart failure and in the acute form of the disease in humans, as well as a stratification strategy to identify patients likely to respond best to its treatments.

More information is available on the company's website: www.corteriapharma.com