Cytokinetics (CYTK) Presents Additional Omecamtiv Mecarbil Phase 2 Data; Improvement in LA Structure, Function Noted

November 14, 2016 4:18 PM EST

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Cytokinetics, Inc. (Nasdaq: CYTK) 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 and left ventricular systolic dysfunction, were presented by Tor Biering-Sørensen, Division of Cardiology, Brigham & Women’s Hospital and Harvard Medical School, in a Clinical Poster Session at the American Heart Association’s Scientific Sessions 2016 in New Orleans. The results presented show that omecamtiv mecarbil improved left atrial (LA) structure and function in patients with chronic heart failure with reduced systolic function. 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 data add to the previously reported results from COSMIC-HF which showed improvements in left ventricular function and volumes following treatment with omecamtiv mecarbil and provide further evidence for the potential for this novel mechanism drug candidate to reverse both ventricular and atrial enlargement in patients with chronic heart failure,” 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 LA structure and function were obtained at baseline, week 12 and week 20 and patients from the PK titration group were compared to the placebo group. The analysis showed that minimum and maximum left atrial volume (LAV) decreased over time, with a statistically significant reduction in minimum LAV at 20 weeks (p=0.032) in patients receiving omecamtiv mecarbil. Similarly, patients receiving omecamtiv mecarbil experienced statistically significant improvements in LA emptying fraction at 12 and 20 weeks (p=0.018, p=0.004, respectively).



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