Amgen, Cytokinetics and Servier have reported mixed results from the Phase III GALACTIC-HF clinical trial of investigational drug omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF).
Omecamtiv mecarbil is a cardiac myosin activator that targets the heart’s contractile mechanisms. The drug is co-developed by Amgen and Cytokinetics, while Servier provides funding and strategic support.
The randomised, double-blind, placebo-controlled, event-driven Phase III trial enrolled 8,256 patients across 35 countries. Participants were given a starting dose of 25mg omecamtiv mecarbil twice daily or oral placebo.
QMS Omecamtiv Mecarbil Immunoassay (OM Test) measured plasma levels of omecamtiv mecarbil in each subject to select appropriate maintenance dose of 50mg/37.5mg/25mg twice daily.
The trial’s primary composite endpoint was time to cardiovascular (CV) death or first heart failure event, such as heart failure hospitalisation and other urgent heart failure treatment.
Secondary endpoints included time to CV death, patient reported outcomes, time to first heart failure hospitalisation, and time to all-cause death.
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According to top-line results from the trial, treatment with the drug candidate showed a statistically significant effect in reducing CV death or heart failure events versus placebo in patients on standard of care treatment.
Though the trial achieved the primary composite efficacy endpoint, it failed to meet the secondary endpoint of a reduction in CV death.
Adverse events, such as major ischemic cardiac events, were observed to be similar in treatment groups.
Additional analyses of data are ongoing and results from GALACTIC-HF are slated to be presented virtually on 13 November this year at the American Heart Association (AHA) Scientific Sessions 2020.
Amgen Research and Development executive vice-president David Reese said: “The outcomes observed in GALACTIC-HF further the understanding of treating heart failure, a devastating disease in which half of heart failure patients will die within five years of initial hospitalisation.”
In September last year, Amgen reported favourable results from the Phase I trial of its investigational cancer drug AMG 510.