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Cytokinetics Announces Results From GALACTIC-HF Presented at Late Breaking Clinical Trial Session at the American Heart Association Scientific Sessions and Published in the New England Journal of Medicine
Trial Met Primary Composite Endpoint of Reduction in Heart Failure Events or Cardiovascular Death; Did Not Meet Secondary Endpoints Including Reduction in
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Trial Met Primary Composite Endpoint of Reduction in Heart Failure Events or Cardiovascular Death; Did Not Meet Secondary Endpoints Including Reduction in Cardiovascular Death\n\n \n \n \n \n \n \n \n \n \n \n \n The Global Toll of Heart Failure, A Time for Action\n \n \n \n \n \n \n \n \n\n Effect of Omecamtiv Mecarbil Consistent Across Most Prespecified Subgroups with Potentially Greater Treatment Effect in Patients with Lower Ejection Fraction at Higher Risk Cytokinetics to Host Investor/Media Event and Webcast on November 13, 2020 at 1:00 PM ET SOUTH SAN FRANCISCO, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the primary results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 event-driven cardiovascular outcomes clinical trial of omecamtiv mecarbil. The results were presented by John Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center and Executive Committee Chair, GALACTIC-HF, in a Late Breaking Clinical Trial session at the American Heart Association (AHA) Scientific Sessions 2020, and were simultaneously published in the New England Journal of Medicine.1 GALACTIC-HF, one of the largest Phase 3 global cardiovascular outcomes trials in heart failure ever conducted, enrolled 8,256 patients who were at risk of hospitalization and death, despite being well treated on standard of care therapy. After a median duration of follow-up of 21.8 months, the trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of 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. A first primary endpoint event occurred in 1,523 of 4,120 patients (37.0%) in the omecamtiv mecarbil group and in 1,607 of 4,112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI] 0.86, 0.99; p=0.025). This effect was observed without evidence of an increase in the overall rates of myocardial ischemic events, ventricular arrhythmias or death from cardiovascular or all causes. The sta...