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Amgen, Cytokinetics and Servier Announce Topline Results From GALACTIC-HF, a Phase 3 Trial of Omecamtiv Mecarbil in Patients With Heart Failure
Trial Met Primary Composite Endpoint of Reduction in Cardiovascular Death or Heart Failure Events Trial Did Not Meet Secondary Endpoint of Reduction in
About this update from Amgen Inc.
[{"type":"text","content":"Trial Met Primary Composite Endpoint of Reduction in Cardiovascular Death or Heart Failure Events \n Trial Did Not Meet Secondary Endpoint of Reduction in Cardiovascular Death Results Will Be Presented in Late Breaking Clinical Trial Session at AHA Scientific Sessions 2020 THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif. and SURESNES, France, Oct. 08, 2020 (GLOBE NEWSWIRE) -- Amgen (NASDAQ:AMGN), Cytokinetics, Incorporated (NASDAQ:CYTK) and Servier today announced topline results from GALACTIC-HF, a Phase 3 pivotal clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF). The results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care (HR: 0.92; 95% CI: 0.86, 0.99, p=0.0252). No reduction in the secondary endpoint of CV death was observed. Adverse events, including major ischemic cardiac events, were balanced between treatment arms. Additional analyses of data are underway and results from GALACTIC-HF will be presented at the American Heart Association (AHA) Scientific Sessions 2020, in a virtual Late Breaking Clinical Trial session on Friday, November 13, 2020 from 10:35-10.45 a.m. CDT. Omecamtiv mecarbil is an investigational cardiac myosin activator, the first of a novel class of myotropes1 designed to directly target the contractile mechanisms of the heart. “The outcomes observed in GALACTIC-HF further the understanding of treating heart failure, a devastating disease in which half of heart failure patients will die within five years of initial hospitalization,” said David M. Reese, M.D. executive vice president of Research and Development at Amgen. “At Amgen, we remain committed to developing and delivering transformative medicines that improve the lives of patients with cardiovascular disease.” “GALACTIC-HF provides insights into effects associated with targeting cardiac muscle contractility with omecamtiv mecarbil to treat heart failure patients with reduced ejection fraction,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ executive vice president of Research & Deve...