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

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  • 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 

Paris, France, July 21, 2025 – 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

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