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COSMIC-HF: Omecamtiv mecarbil improves cardiac function in patients with chronic HF
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Amgen and Cytokinetics announced that top-line results from the expansion phase of the COSMIC-HF study of omecamtiv mecarbil for treatment of patients with chronic HF were positive.
COSMIC-HF is a double blind, placebo-controlled phase 2 trial conducted in two parts. The initial dose-escalation phase was completed in 2013. The expansion phase is evaluating the pharmacokinetics, pharmacodynamics, safety and tolerability of omecamtiv mecarbil (Amgen and Cytokinetics), a cardiac myosin activator that works by increasing cardiac contractility, in 448 patients with chronic HF and left ventricular systolic dysfunction, according to a press release issued by both companies.
The results from the expansion phase indicated that patients assigned omecamtiv mecarbil exhibited statistically significant improvement in cardiac function parameters such as systolic ejection time, stroke volume and N-terminal pro-brain natriuretic peptide at 20 weeks compared with those assigned placebo. Pharmacokinetic-based dose titration controlled patient exposure to the drug and enabled decreases in cardiac dimensions and heart rate, the companies stated in the release.
Adverse events, serious adverse events and cardiac adverse events were similar among those assigned omecamtiv mecarbil and those assigned placebo, and while those assigned omecamtiv mecarbil had a small increase in troponin, in no case did it lead to MI or myocardial ischemia, according to the release.
The companies stated that the full results will be submitted for publication and for presentation at a future conference.