Imbria Reports Positive Topline Results for Investigational New Drug Ninerafaxstat in Patients with Non-obstructive Hypertrophic Cardiomyopathy
BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company developing novel therapies designed to improve patient symptoms and function by enhancing cellular energetics, today announced positive topline results from the Phase 2 IMPROVE-HCM clinical trial, evaluating ninerafaxstat, a novel cardiac mitotrope and partial fatty acid oxidation (pFOX) inhibitor, in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), a large orphan disease with no approved therapies.
- Treatment with ninerafaxstat was well tolerated and no safety signals were observed.
- At 12-weeks, treatment with ninerafaxstat showed a statistically significant improvement in a robust functional cardiopulmonary exercise test (CPET) measure of established prognostic significance in patients with nHCM and heart failure with preserved ejection fraction (HFpEF).
- “Based on the topline results from IMPROVE-HCM, we are focused on advancing ninerafaxstat into a Phase 3 clinical trial of patients with nHCM and plan to meet with regulatory agencies within the coming months to confirm trial design.
- Imbria anticipates sharing full data from the IMPROVE-HCM Phase 2 clinical trial at an upcoming medical conference.