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 controls. Patients were randomized in a 2:1 fashion to omecamtiv mecarbil, starting at 25 mg twice daily and titrated to 25, 37.5 or 50 mg twice daily based on the same PK-guided dosing regimen as used in GALACTIC-HF, the Phase 3 cardiovascular outcomes trial of omecamtiv mecarbil, or to placebo. The primary endpoint is the change in peak oxygen uptake (pVO2) on CPET from baseline to Week 20. Secondary endpoints include the change in total workload during CPET from baseline to Week 20 and the change in the average daily activity units measured over a 2-week period from baseline (Week -2 to Day 1) to Week 18-20 as determined using accelerometry.
About Omecamtiv Mecarbil and the Phase 3 Clinical Trials Program
Omecamtiv mecarbil is an investigational selective cardiac myosin activator, the first of a novel class of myotropes1 designed to directly target the contractile mechanisms of the heart, binding to and recruiting more cardiac myosin heads to interact with actin during systole. Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption.2-4 Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction.
Omecamtiv mecarbil is being developed for the potential treatment of HFrEF and is the subject of a comprehensive Phase 3 clinical trials program composed of GALACTIC-HF and METEORIC-HF. The results from GALACTIC-HF, published in the New England Journal of Medicine, demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of time to first heart failure event (heart failure hospitalization and other urgent treatment for heart failure) or cardiovascular (CV) death compared to placebo in patients treated with standard of care (hazard ratio, 0.92; 95% confidence interval [CI] 0.86, 0.99; p=0.025). No reduction in the secondary endpoint of time to CV death was observed in the overall population.5 Supplemental analyses indicated a greater treatment effect in patients with a lower LVEF (LVEF ≤28%, n=4,456, hazard ratio, 0.84; 95% CI 0.77, 0.92; interaction p=0.003). Effects in GALACTIC-HF were observed without evidence of an increase in the overall rates of myocardial ischemic events, ventricular arrhythmias or death from cardiovascular or all causes.
About Heart Failure
Heart failure is a grievous condition that affects more than 64 million people worldwide6 about half of whom have reduced left ventricular function.7,8 It is the leading cause of hospitalization and readmission in people age 65 and older.9,10 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.11 An estimated one in five people over the age of 40 are at risk of developing heart failure, and approximately 50 percent of people diagnosed with heart failure are expected to die within five years of initial hospitalization.12,13 More than 2 million people in the U.S. are estimated to have an ejection fraction