In the phase 2 IMPROVE-HCM trial, cardiac mitotrope ninerafaxstat was safe, with a signal of improved cardiac function in moderate nonobstructive hypertrophic cardiomyopathy.
ATLANTA — A investigative drug that uses a novel pathway to target cardiac metabolism was safe and well-tolerated and showed a signal to improve cardiac function in symptomatic patients with moderate nonobstructiveThe IMPROVE-HCM trial randomized 67 nHCM patients to the drug ninerafaxstat or placebo. Ninerafaxstat is a cardiac mitotrope, a class of drugs that influence myocardial energetics.
As a phase 2 trial, the study was designed to evaluate the safety of ninerafaxstat over 12 weeks. The study demonstrated comparable safety results in terms of treatment emergent adverse events — 11% and 6% for the treatment and placebo arms, respectively. The statistically significant difference in exercise capacity was demonstrated in a cohort of patients with worst symptoms, defined by a baseline KCCQ-CSS of ≤ 80, Maron said. "These are patients that are, if you look at KCCQ-CSS of 80 to 60 for a score, frustrated but they're not super sick," Maron told."What we're saying is, we're trying to remove the asymptomatic to mildly symptomatic patient out of the trial because we're not going to show benefit.
"The mitotropes are altering the utilization of energy to a more efficient form," Maron said.
Exercise Physical Activity Hypertrophic Cardiomyopathy Heart Failure Heart Metabolism Metabolic Fatty Acids Kansas Massachusetts Pennsylvania Ventilator Medical Ventilator Mechanical Ventilation
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