Phase III trial with cardiac myosin activator meets primary endpoint in HFrEF patients

Results from the phase III GALACTIC-HF trial in HFrEF patients randomized to omecamtiv mecarbil or placebo showed that the primary outcome was met: a significant reduction in CV death and HF events (HF hospitalization and other urgent treatment for HF) with omecamtiv mecarbil compared to placebo (HR 0.92, 95%CI: 0.86-0.99, P=0.0252). Omecamtiv mecarbil failed to reduce the secondary endpoint of CV death. Adverse events were balanced between the two groups.

Omecamtiv mecarbil is a selective cardiac myosin activator, that is designed to increase the contractility of the heart. The primary endpoint in the GALACTIC-HF trial was time to CV death or first HF event, such as HF hospitalization and other emergency treatment for HF. Secondary outcomes were time to CV death, changes in patient reported outcome, time to first heart failure hospitalization, and time to all-cause mortality.

The Global Approach to Lowering Adverse Cardiac outcome Through Improving Contractility in Heart Failure (GALACTIC-HF) trial is a double-blind, randomized, placebo-controlled, multicenter study that enrolled 8256 patients with chronic symptomatic NYHA class II to IV, HF and reduced ejection fraction (LVEF ≤35%), elevated natriuretic peptides, and either hospitalization for HF or emergency visit for HF within one year of screening. Patients were randomized to either omecamtiv mecarbil 25, 37.5, or 50 mg twice daily or placebo for up to 208 weeks. Results will be presented at the virtual 2020 meeting of the American Heart Association at a Late Breaking Clinical Trial Session upcoming November.

Source: press release Amgen, October 8, 2020