Cytokinetics advances omecamtiv mecarbil into Phase III as a potential treatment for chronic heart failure.

Cytokinetics announced the advancement of omecamtiv mecarbil to Phase III clinical development with a cardiovascular outcomes clinical trial expected to initiate in the fourth quarter of 2016. Omecamtiv mecarbil, a novel investigational cardiac myosin activator, enhances cardiac function by increasing cardiac contractility and is being developed for the potential treatment of patients with chronic heart failure.

The decision to proceed to Phase III development follows the review of results from prior clinical trials, including COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase II clinical trial evaluating omecamtiv mecarbil in patients with chronic heart failure. Data from COSMIC-HF were first presented in a Late-Breaking Clinical Trial session at the American Heart Association Scientific Sessions 2015. COSMIC-HF met its primary pharmacokinetic objective and demonstrated statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group employing pharmacokinetic-based dose titration. In addition, Amgen and Cytokinetics have convened meetings with regulatory authorities to inform plans for omecamtiv mecarbil in a Phase III clinical trials program.

Comment: Servier Laboratories has rights to commercialize omecamtiv mecarbil in Europe.