Cytokinetics Provides Update Regarding Omecamtiv Mecarbil Clinical Development Program
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Cytokinetics, Incorporated has announced that, in the first half of 2011, the company and its partner, Amgen Inc., plan to initiate a Phase IIb clinical trial of an intravenous formulation of omecamtiv mecarbil to evaluate its safety and efficacy in patients with left ventricular systolic dysfunction hospitalized for acute heart failure.
This trial will be conducted by Amgen in collaboration with Cytokinetics. Amgen holds an exclusive, world-wide (excluding Japan) license to omecamtiv mecarbil and related compounds, subject to specified development and commercialization participation rights of Cytokinetics.
"This Phase IIb clinical trial was designed to evaluate specific heart failure symptoms to assess the potential clinical efficacy, safety, and tolerability of omecamtiv mecarbil for the treatment of patients hospitalized for acute heart failure," stated Andrew A. Wolff, MD, FACC, Cytokinetics' Senior Vice President of Clinical Research and Development and Chief Medical Officer.
"The objective of this clinical trial is to determine if the increases in left ventricular systolic function observed in patients with stable heart disease treated with omecamtiv mecarbil in an earlier Phase IIa trial may translate into a clinical benefit in patients hospitalized for acute heart failure, a large and growing population that is underserved by currently available treatments."
"This Phase IIb clinical trial represents a significant step forward for this program," stated Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "The progress in the clinical development of omecamtiv mecarbil, combined with the recent successful completion of an Evidence of Effect Phase IIa clinical trial of our fast skeletal muscle troponin activator, CK-2017357, in patients with ALS, demonstrates the promise of our focused research and development activities in the biology of muscle function."
Phase IIb Clinical Trial of Omecamtiv Mecarbil
This Phase IIb clinical trial is planned to be an international, multicenter, randomized, double-blind, placebo-controlled study in approximately 600 patients, enrolled sequentially in 3 ascending-dose cohorts. In each cohort, patients will be randomized to receive omecamtiv mecarbil or placebo. The primary objective of the Phase IIb clinical trial will be to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared to placebo on dyspnea (or shortness of breath) in patients with left ventricular systolic dysfunction hospitalized for acute heart failure.
The secondary objectives are to assess the safety and tolerability of 3 dose levels of IV omecamtiv mecarbil compared with placebo and to evaluate the effects of 48 hours of treatment with IV omecamtiv mecarbil on additional measures of dyspnea, patients' global assessments, change in N-terminal pro brain-type natriuretic peptide (a biomarker associated with the severity of heart failure) and short-term clinical outcomes in these patients. In addition, the trial will evaluate the relationship between omecamtiv mecarbil plasma concentrations and echocardiographic parameters in patients with acute heart failure.
