Cytokinetics Announces Start of COMET-HF, a Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction

SOUTH SAN FRANCISCO, Calif., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure (HF) with severely reduced ejection fraction, is open to enrollment. Omecamtiv mecarbil is a novel investigational selective cardiac myosin activator in development for the potential treatment of heart failure with severely reduced ejection fraction. COMET-HF is being conducted in collaboration with Duke Clinical Research Institute (DCRI), a leading academic research organization.

“We are pleased to be starting COMET-HF to evaluate omecamtiv mecarbil in patients with severe heart failure who have limited treatment options and remain at high risk after failing guideline-directed medical therapy,” said Stuart Kupfer, M.D., Senior Vice President, Chief Medical Officer. “The design of COMET-HF is informed by encouraging data from GALACTIC-HF as well as extensive discussions with FDA and the heart failure community. This confirmatory trial has pragmatic features intended to improve the efficiency of study conduct and reduce patient burden. We hope to generate additional evidence of the potential treatment benefit of omecamtiv mecarbil among these heart failure patients with high unmet need.”

“Heart failure, and especially more severe forms of heart failure, is an area of major unmet need despite recent progress in developing more effective treatments,” said DCRI faculty member Michael Felker, M.D., M.H.S, Professor of Medicine and Cardiovascular Research Therapeutic Area Lead, and Principal Investigator for COMET-HF. “These patients are at high risk of heart failure hospitalization and death despite existing therapies, highlighting the critical need for new treatments. Through DCRI’s collaboration with Cytokinetics, we expect to leverage our decades of expertise in conducting cardiovascular clinical trials and advance our shared commitment to innovation in service of patients.”

COMET-HF is a Phase 3 multinational, multi-center, double-blind, randomized, placebo-controlled trial designed to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction. The primary endpoint of COMET-HF is the time to first event in the primary composite endpoint of cardiovascular death, first heart failure event, left ventricular assist device (LVAD) implantation or cardiac transplantation, or stroke. Secondary endpoints will evaluate the risk of individual components, including heart failure hospitalization, cardiovascular death, and stroke, as well as the risk of irreversible morbidity/mortality based on the composite endpoint of cardiovascular death, LVAD or cardiac implantation, or stroke.

COMET-HF is expected to randomize approximately 1,800 patients on a 1:1 basis to receive omecamtiv mecarbil or placebo. At screening, patients enrolled in COMET-HF must have symptomatic heart failure with severely reduced ejection fraction defined as left ventricular ejection fraction