Omecamtiv Mecarbil

In collaboration with Amgen, Cytokinetics is developing omecamtiv mecarbil, a novel activator of cardiac myosin, the motor protein that powers cardiac muscle contraction. It is being investigated as a potential treatment for heart failure.

Omecamtiv mecarbil, an investigational drug candidate, is designed to increase the duration of cardiac muscle contractility and improve cardiac muscle performance, potentially helping patients preserve cardiac function and quality of life, avoid hospitalizations, and decrease the risk of mortality due to heart failure. Certain current treatments for heart failure improve cardiac muscle performance by increasing cellular concentration of calcium thereby increasing heart rate, blood pressure and arrhythmias (irregular heart rhythms), and ultimately may increase the risk of mortality. Increasing the speed or velocity of muscle contraction may also shorten the duration of systolic ejection time—the time it takes for the blood to leave the heart chamber and enter systemic circulation. Cytokinetics’ cardiac muscle activator stimulates cardiac myosin to increase cardiac performance without increasing cellular calcium concentrations.

Omecamtiv mecarbil was the subject of four Phase 2 clinical trials, including a trial called COSMIC-HF that evaluated oral omecamtiv mecarbil in patients with chronic heart failure and left ventricular systolic dysfunction.

Omecamtiv mecarbil is currently the subject of a Phase 3 clinical trials program. The first Phase 3 trial, GALACTIC-HF, is a double-blind, randomized, placebo-controlled multicenter clinical trial conducted by Amgen in collaboration with Cytokinetics. It is designed to evaluate 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. GALACTIC-HF will enroll approximately 8,000 patients with chronic heart failure with reduced ejection fraction in approximately 900 sites in 35 countries, and is being conducted under a Special Protocol Assessment (SPA) with the FDA.