Amgen, Cytokinetics and Servier have opened enrolment in the Phase III METEORIC-HF clinical trial of omecamtiv mecarbil for the treatment of heart failure patients with reduced ejection fraction (HFrEF).
Omecamtiv mecarbil is a selective cardiac myosin activator designed to bind to the catalytic domain of myosin. It is being co-developed by Amgen and Cytokinetics, with funding and support from Servier.
The randomised, parallel group, multi-centre METEORIC-HF trial will assess the effect of omecamtiv mecarbil on exercise capacity, compared to placebo.
The exercise capacity will be determined using cardiopulmonary exercise testing (CPET) after 20 weeks of treatment in a total of about 270 patients across the US, Canada and Europe.
Primary endpoint of the placebo-controlled, double-blind trial is a change in peak oxygen uptake (pVO2) on CPET from baseline to week 20.
Its secondary endpoints include a change in total workload during CPET and change in the average daily activity units measured over a two-week period as determined using accelerometry.
Cytokinetics Research & Development executive vice-president Fady Malik said: “The start of this second Phase III clinical trial marks an important milestone in the expansion of our clinical trials programme for omecamtiv mecarbil, testing the hypothesis that improving cardiac function with a drug candidate that directly increases myocardial contractility may improve exercise capacity.
“Exercise intolerance, typically manifested by shortness of breath and fatigue on exertion, is a predominant symptom of chronic heart failure and often the first symptom that prompts patients to seek medical care. If positive, this clinical trial may provide key clinically relevant evidence.”
Omecamtiv mecarbil is also being studied in another Phase III trial called GALACTIC-HF, which is a cardiovascular outcomes study designed to recruit around 8,000 patients at more than 900 sites in 35 countries.
This trial is intended to study the ability of omecamtiv mecarbil in combination with standard of care to minimise the risk of heart failure events and cardiovascular (CV) death in patients with chronic heart failure with reduced ejection fraction.