Cytokinetics has begun dosing patients in Japan in a Phase III cardiovascular outcomes clinical trial (GALACTIC-HF) of omecamtiv mecarbil as a potential heart failure treatment.
Currently being developed in collaboration with Amgen, omecamtiv mecarbil is an investigational cardiac myosin activator designed to increase cardiac contractility.
The double-blind, randomised, placebo-controlled multi-centre GALACTIC-HF trial will evaluate the ability of omecamtiv mecarbil and standard-of-care combination to minimise the risk for cardiovascular death or heart failure in patients with high chronic heart failure risk and decreased ejection fraction.
Expected to enrol around 8,000 subjects with symptomatic chronic heart failure at more than 800 centres in 34 countries, the trial is being performed by Amgen in partnership with Cytokinetics.
Dosing of the first patient in Japan triggers a milestone payment of $10m from Amgen.
Last month, the firm reported positive results from a Phase II Japanese trial with omecamtiv mecarbil.
The Phase II trial assessed the safety, tolerability, pharmacokinetics and cardiac function effect of omecamtiv mecarbil in patients with chronic heart failure.
Results indicated that the trial met its pharmacokinetic primary endpoint and a secondary endpoint of statistically significant improvement in systolic ejection time (SET).
The trial’s pharmacodynamics, pharmacokinetics, tolerability and safety data was found to be consistent with that of previous trials.
Subject to Cytokinetics’ specified development and commercialisation rights, Amgen holds an exclusive, worldwide licence to omecamtiv mecarbil and related compounds.
Amgen also partnered with French company Servier for exclusive commercialisation rights in Europe and the Commonwealth of Independent States.