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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
Top Line Results of METEORIC-HF Expected in Early 2022 Company Plans to Submit NDA in 2H 2021 Based on Positive Results of GALACTIC-HF SOUTH SAN FRANCISCO,
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Top Line Results of METEORIC-HF Expected in Early 2022 Company Plans to Submit NDA in 2H 2021 Based on Positive Results of GALACTIC-HF SOUTH SAN FRANCISCO, Calif., June 15, 2021 (GLOBE NEWSWIRE) -- 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.” About METEORIC-HF METEORIC-HF opened to enrollment in early 2019 and was designed to enroll 270 patients with HFrEF at sites throughout the U.S., Canada and Europe to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by CPET. Patients are required to have a left ventricular ejection fraction (LVEF) ≤35 percent, New York Heart Association (NYHA) heart failure class II or III and reduced exercise capacity compared to age matched...