Cytokinetics to start GALACTIC-HF Phase 3 clinical trial of omecamtiv mecarbil
Cytokinetics announced the activation of the first clinical site and the start of GALACTIC-HF, the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil which is being conducted by Amgen, in collaboration with Cytokinetics. Coincident with the start of the trial, Amgen will make a $26.7M milestone payment to Cytokinetics. In clinical studies, omecamtiv mecarbil, a novel investigational cardiac myosin activator, has been shown to enhance cardiac function by increasing cardiac contractility and is being developed for the potential treatment of patients with chronic heart failure. The primary objective of this double-blind, randomized, placebo-controlled multicenter clinical trial is to determine if treatment with omecamtiv mecarbil when added to standard of care is superior to standard of care plus placebo in reducing the risk of cardiovascular death or heart failure events in patients with high risk chronic heart failure and reduced ejection fraction. GALACTIC-HF will be conducted under a Special Protocol Assessment with the U.S. FDA.