SOUTH SAN FRANCISCO, Calif., Feb. 15, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced topline results from METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF). Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction.
METEORIC-HF evaluated the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) following 20 weeks of treatment in patients with HFrEF receiving standard of care therapy. The trial completed enrollment of 276 patients in June 2021. There was no effect on the primary endpoint, which was the change in peak oxygen uptake (pVO2) on CPET from baseline to Week 20 in patients treated with omecamtiv mecarbil compared to placebo. Adverse events, including major cardiac events, were similar between the treatment arms and the safety profile of omecamtiv mecarbil in METEORIC-HF was consistent with prior clinical trials including GALACTIC-HF. Results from METEORIC-HF will be presented at the American College of Cardiology (ACC) 71st Annual Scientific Session & Expo, in a Late Breaking Clinical Trial session on Sunday, April 3, 2022 from 9:45-9:55 a.m. ET.
“While medical therapies have demonstrated significant reductions in the risk of adverse clinical outcomes in heart failure patients with reduced ejection fraction, as was also observed with omecamtiv mecarbil in GALACTIC-HF, demonstrating an improvement in exercise capacity with these same medical therapies has been elusive,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “These neutral results from METEORIC-HF may provide new insights into the role of cardiac function in determining exercise capacity relative to other potential contributors such as skeletal muscle dysfunction. We are grateful to the trial investigators, site personnel, patients and caregivers who participated in the METEORIC-HF, especially given challenges posed by the pandemic.”