Cytokinetics Announces Additional Results From COSMIC-HF at the American Heart Association Scientific Sessions 2017

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2017 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (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 clinical trial evaluating omecamtiv mecarbil in patients with chronic heart failure and left ventricular systolic dysfunction, were presented by John Teerlink, M.D. in an Abstract Rapid Fire Oral presentation at the American Heart Association Scientific Sessions 2017 in Anaheim, Calif. Dr. Teerlink is Professor of Clinical Medicine at the University of California San Francisco and Director of Heart Failure at the San Francisco Veterans Affairs Medical Center. In this post-hoc responder analysis, the proportion of patients achieving various thresholds in the percent reduction of NT-proBNP were larger in patients who received omecamtiv mecarbil than in patients who received placebo. 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. “NT-proBNP is a biomarker of ventricular wall stress, with higher levels reflecting more severe heart failure,” said Fady I. Malik, MD, PhD, Cytokinetics’ Executive Vice President of Research & Development. “This analysis showed that omecamtiv mecarbil reduces NT-proBNP in a potentially meaningful way, consistent with a reduction in ventricular wall stress. With these positive changes observed for NT-proBNP and other measures relevant to heart failure in COSMIC-HF, we now look forward in GALACTIC-HF to learning if omecamtiv mecarbil can improve clinical outcomes in patients with heart failure.” 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 trial 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. This post-hoc responder analysis evaluated percent changes in NT-proBNP between patients receiving placebo or omecamtiv mecarbil from baseline to week 20 in the PK titration group of COSMIC-HF. Responders were defined as those patients who achieved various thresholds in the percent reduction of NT-proBNP from baseline to 20 weeks. The percentage of patients receiving omecamtiv mecarbil and meeting each responder definition was compared to the corresponding percentage of patients in the placebo group meeting the same responder definition. In patients receiving omecamtiv mecarbil compared to placebo, there was a statistically significant greater proportion of responders at each threshold except for that evaluating a > 50 percent decrease from baseline. Percent decrease in NT‑proBNP from baseline to 20 weeks Proportion of Responders Omecamtiv Mecarbil Placebo p value > 20% 48 % 36 % 0.047 > 30% 42 % 30 % 0.047 > 40% 33 % 21 % 0.039 > 50% 20 % 15 % >0.05

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