CRAFT-WHF Phase II 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 randomised, 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 I trial results, Corteria has initiated the CRAFT-WHF Phase II randomised, double-blind, placebo-controlled trial in patients with WHF (NCT06815471/EU CT 2024-518951-52).
It will enrol 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 I 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 I randomised, 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; a 12-week multiple ascending dose (MAD) phase is now under way 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 coadministered 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 remodelling.
A Phase Ib 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 II and expand our footprint in cardiometabolic diseases.”