Cytokinetics opens enrollment for COMET-HF Phase 3 trial

Cytokinetics (CYTK) announced that COMET-HF, a confirmatory Phase 3 clinical trial of omecamtiv mecarbil in patients with symptomatic heart failure 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. 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 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 less than30%, NT-proBNP greater than or equal to1,000 pg/mL, and a heart failure event within the preceding six months.