- Trial Met Primary Composite Endpoint of Reduction in Cardiovascular Death or Heart Failure Events
- 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., SOUTH SAN FRANCISCO, Calif., and SURESNES, France, Oct. 8, 2020 /PRNewswire/ -- Amgen, Cytokinetics, Incorporated 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 myotropes designed to directly target the contractile mechanisms of the heart.
Omecamtiv mecarbil is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF) under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier.
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