Benzinga | Jun 15, 2021 07:32AM EDT

Cytokinetics Announces Completion Of Enrollment In METEORIC-HF, The Second Phase 3 Clinical Trial Of Omecamtiv Mecarbil In Patients With Heart Failure With Reduced Ejection Fraction

Cytokinetics, Incorporated (NASDAQ:CYTK) today announced the completion of patient enrollment in METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 clinical trial of omecamtiv mecarbil. METEORIC-HF is designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET) in patients with heart failure with reduced ejection fraction (HFrEF).

"We would like to thank the investigators and clinical site coordinators for their commitment to METEORIC-HF, particularly given the challenges they overcame enrolling a trial in the midst of a global pandemic," said Fady I. Malik, M.D., Ph.D., Cytokinetics' Executive Vice President of Research & Development. "Based on recent interactions with FDA, we plan to submit the New Drug Application for omecamtiv mecarbil this year based on results from GALACTIC-HF. Results from METEORIC-HF are expected in early 2022 and may further elaborate on potential effects in patients with severe heart failure."

"Exercise intolerance is a common symptom among people suffering from heart failure with reduced ejection fraction and can seriously limit quality of life," said Gregory Lewis, M.D., Heart Failure Section Head and Director, Cardiopulmonary Exercise Testing Laboratory, Massachusetts General Hospital. "We look forward to assessing whether improvement in cardiac contractility by a novel mechanism cardiac myosin activator may increase exercise capacity and potentially lead to greater mobility and function for patients living with HFrEF."