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Adding Japan to GALACTIC-HF
SOUTH SAN FRANCISCO, Calif.—Cytokinetics in early August announced that the Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients with heart failure has met its pharmacokinetic primary endpoint and demonstrated statistically significant improvements in systolic ejection time, a secondary endpoint. Omecamtiv mecarbil, a novel investigational cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure.
“We are pleased that this Phase 2 trial of omecamtiv mecarbil met its objectives in this population of Japanese heart failure patients,” said Dr. Fady I. Malik, Cytokinetics’ executive vice president of research and development. “The pharmacokinetics, pharmacodynamics, safety and tolerability data from this trial were consistent with previously reported results from COSMIC-HF. We are now collaborating with Amgen on start-up activities for Japanese sites to participate in GALACTIC-HF.”
Cytokinetics is eligible to earn a $10 million milestone payment from Amgen upon the first dosing of a patient in Japan in GALACTIC-HF, the ongoing Phase 3 cardiovascular clinical outcomes trial of omecamtiv mecarbil.
GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) is a Phase 3, double-blind, randomized, placebo-controlled multicenter clinical trial designed 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 is planned to enroll approximately 8,000 symptomatic chronic heart failure patients in over 800 sites in 34 countries who are either currently hospitalized for a primary reason of heart failure or have had a hospitalization or admission to an emergency room for heart failure within one year prior to screening.
Omecamtiv mecarbil is a novel cardiac myosin activator. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. Cardiac myosin activators are thought to accelerate the rate-limiting step of the myosin enzymatic cycle and shift the enzymatic cycle in favor of the force-producing state. Preclinical research has shown that cardiac myosin activators increase contractility in the absence of changes in intracellular calcium in cardiac myocytes.