SOUTH SAN FRANCISCO, Calif., March 20, 2017 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (NASDAQ:CYTK) today announced that additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, were presented by Tor Biering-Sørensen, MD, PhD, Postdoctoral Research Fellow, Division of Cardiology, Brigham & Women's Hospital and Harvard Medical School, in a Poster Session at the American College of Cardiology's 66th Annual Scientific Session (ACC.17) in Washington, D.C. The results presented showed that omecamtiv mecarbil improved myocardial deformation, a marker of myocardial function that has been related to outcomes. Omecamtiv mecarbil, a novel investigational cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure.
"These results provide the first, direct echocardiographic evidence in humans that increases in the contractility of cardiac muscle underlie the improvements in overall cardiac function observed in COSMIC-HF," said Fady I. Malik, MD, PhD, Cytokinetics' Executive Vice President, Research and Development.
COSMIC-HF: Expansion Phase Design and Results
The expansion phase of COSMIC-HF evaluated the pharmacokinetics, pharmacodynamics, safety and tolerability of oral omecamtiv mecarbil in 448 patients with chronic heart failure and left ventricular systolic dysfunction. Patients were randomized 1:1:1 to receive either placebo or treatment with omecamtiv mecarbil dosed as 25 mg twice daily or 25 mg twice daily with dose escalation to 50 mg twice daily, depending on a plasma concentration of omecamtiv mecarbil after two weeks of treatment. The study met its primary pharmacokinetic objective and showed statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group receiving pharmacokinetic-based (PK) dose titration.
In this analysis, measures of left ventricular (LV) myocardial deformation, including global circumferential strain (GCS) and mean global longitudinal strain (GLS), were compared at baseline and at 20 weeks of treatment in the placebo group, the 25 mg twice daily group, and the PK-guided dose titration group. At 20 week