Cytokinetics presented new data from post-hoc analyses of the GALACTIC-HF trial at the American Heart Association Scientific Sessions 2024, suggesting that omecamtiv mecarbil may offer treatment benefits for high-risk heart failure patients, including older individuals and those with recent ventricular arrhythmias. These findings support the ongoing development of omecamtiv mecarbil, with a confirmatory Phase 3 trial, COMET-HF, expected to begin in Q4 2024.
Omecamtiv Mecarbil's Impact Across Age Groups
The GALACTIC-HF trial, involving 8,232 patients, showed that the treatment effect of omecamtiv mecarbil was consistent across different age groups (interaction p=0.73). Specifically, in patients with severe heart failure, omecamtiv mecarbil reduced the risk for the primary outcome of cardiovascular death or heart failure events, with hazard ratios of 0.77 (95% CI, 0.64-0.92) for patients under 65 and 0.83 (95% CI, 0.71-0.97) for those 65 and older (interaction p=0.72). These relative risk reductions translated to absolute risk reductions of 8.6 and 7.9, respectively. Adverse events of special interest, such as ventricular arrhythmias and myocardial ischemic events, were similar between the omecamtiv mecarbil and placebo groups in both age categories.
Ventricular Arrhythmias and Omecamtiv Mecarbil
The analysis also investigated the clinical consequences of ventricular arrhythmias (VA) in GALACTIC-HF patients. The occurrence of VA was associated with a significantly higher risk of the primary endpoint (HR 1.67; 95% CI 1.42-1.97; p<0.001) and all-cause mortality (HR 2.07; 95% CI 1.77-2.42; p<0.001). Notably, omecamtiv mecarbil did not increase the occurrence of VA, and in patients with lower left ventricular ejection fraction (LVEF ≤28%), treatment with omecamtiv mecarbil appeared to reduce the risk for the composite outcome of VA, cardiac arrest, and sudden death (HR 0.77, 95% CI 0.63-0.94; p=0.009).
About Omecamtiv Mecarbil
Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator designed to improve cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption. It is currently under development for the treatment of heart failure with reduced ejection fraction (HFrEF).
COMET-HF Trial
Cytokinetics is preparing to initiate COMET-HF, a confirmatory Phase 3 clinical trial, to further evaluate the efficacy of omecamtiv mecarbil in patients with symptomatic heart failure and severely reduced ejection fraction. This trial aims to confirm the potential of omecamtiv mecarbil to reduce the risk of adverse heart failure outcomes in this high-risk population.
