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Cytokinetics Announces Publication Relating to Design of GALACTIC-HF, a Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients With Heart Failure
Second Interim Analysis in GALACTIC-HF Expected to Occur in Q1 2020 Topline Results Expected in Q4 2020 SOUTH SAN FRANCISCO, Calif., Feb. 06, 2020 (GLOBE
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Second Interim Analysis in GALACTIC-HF Expected to Occur in Q1 2020\n Topline Results Expected in Q4 2020 SOUTH SAN FRANCISCO, Calif., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the publication of a manuscript relating to the design of 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 in the Journal of American College of Cardiology: Heart Failure (JACC: HF). Omecamtiv mecarbil, a selective cardiac myosin activator, is being developed for the potential treatment of heart failure with reduced ejection fraction under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier. “GALACTIC-HF is not only one of the largest clinical trials of heart failure ever conducted but it has been designed to enroll a population of heart failure patients who are at high risk for cardiovascular events despite receiving standard of care therapies,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President, Research and Development. “This publication outlines key design elements of the trial including the statistical hypotheses being tested. We look forward to the second interim analysis of GALACTIC-HF later in this quarter and the final results from this clinical trial later this year.” GALACTIC-HF: Designed to Enroll High Risk Patients from Inpatient and Outpatient Settings GALACTIC-HF is designed to evaluate whether treatment with omecamtiv mecarbil, dosed twice-daily in accordance with a pharmacokinetic-guided dose selection regimen, when added to standard of care, reduces the risk of heart failure events (heart failure hospitalization or other urgent, unscheduled treatment for heart failure) and cardiovascular (CV) death in patients with chronic heart failure and reduced ejection fraction. GALACTIC-HF opened to enrollment in late 2016 and was designed to enroll approximately 8,000 heart failure patients with reduced ejection fraction at over 1,000 sites in 35 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 a primary reason of heart failure within one year prior to screening. Patients were als...