Cytokinetics, Inc. (CYTK)

[H2R]

CYTOKINETICS ANNOUNCES START OF GALACTIC-HF, A PHASE 3 CLINICAL TRIAL OF OMECAMTIV MECARBIL

http://ir.cytokinetics.com/phoenix.zhtml?c=142156&p=RssLanding&cat=news&id=2226794

GALACTIC-HF: Trial Design

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. In order to be eligible to participate in GALACTIC-HF patients should have an LVEF ≤ 35%, be NYHA class II to IV, and have an elevated BNP or NT-proBNP. Patients will be randomized to either placebo or omecamtiv mecarbil with dose titration up to a maximum dose of 50 mg twice daily based on the plasma concentration of omecamtiv mecarbil after initiation of drug therapy. The primary endpoint is a composite of time to cardiovascular death or first heart failure event, which is defined as either a hospitalization for heart failure or other urgent treatment for worsening heart failure. Secondary endpoints include time to cardiovascular death; patient reported outcomes as measured by the Kansas City Cardiomyopathy Questionnaire Total Symptom Score; time to first heart failure hospitalization; and all-cause death. For additional information, please visit bit.ly/2fC2wtp.