US-based pharmaceutical company Imbria Pharmaceuticals has finished enrolling patients in its IMPROVE-HCM Phase II clinical trial of ninerafaxstat for non-obstructive hypertrophic cardiomyopathy (nHCM).
The placebo-controlled, randomised, double-blind study primarily aims to evaluate the safety and tolerability of ninerafaxstat in patients with symptomatic nHCM.
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Objective evidence of exercise limitation through evaluation of the incidence and severity of treatment-emergent adverse events is also part of the trial’s primary objective.
Ninerafaxstat’s efficacy will be evaluated through assessments of myocardial energetics, maximal and submaximal exercise responses, as well as myocardial diastolic and systolic function.
Efficacy evaluations will also include recovery, symptoms, arrhythmia burden and patient-reported health status in nHCM patients who receive 200mg BID of ninerafaxstat for 12 weeks.
Imbria Pharmaceuticals president and CEO Anne Prener said: “The data from our Phase II trial, assessing cardiac energetics and function, patient symptoms and exercise capacity, will serve as an integral part of our planned regulatory strategy and potentially support a Phase III registrational trial.
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By GlobalData“We look forward to reporting topline data from this trial in the fourth quarter of this year.”
Topline Phase II results from the IMPROVE-ISCHEMIA clinical trial in patients with stable angina are also expected later.
Imbria is currently enrolling patients with cardiometabolic heart failure with preserved ejection fraction (HFpEF) in its IMPROVE-DiCE open-label clinical trial.
Interim data from this trial are expected in the fourth quarter of this year.
Ninerafaxstat is a partial fatty acid oxidation inhibitor that intends to shift the heart’s preference from fatty acids towards glucose, thereby improving cardiac function both at rest and during exercise.
The drug is currently in Phase II clinical development for the indications of nHCM, stable angina and HFpEF.
Based in Boston, Massachusetts, Imbria Pharmaceuticals is a privately held company that develops novel therapies for patients with life-altering cardiometabolic disorders.
