Imbria Pharmaceuticals announced positive Phase 2 trial results for ninerafaxstat in patients with cardiometabolic heart failure with preserved ejection fraction (HFpEF). The trial demonstrated that ninerafaxstat improved cardiac energetics, left ventricular reserve capacity, exercise capacity, and patient-reported symptoms. This is a significant advancement as it addresses a large and growing patient population with limited treatment options.
This news is particularly important because HFpEF represents a significant unmet medical need. Current treatments offer limited efficacy, especially for the cardiometabolic phenotype, which comprises a large portion of HFpEF patients. Ninerafaxstat’s positive impact on cardiac energetics, a core issue in HFpEF, offers a new therapeutic approach. The observed improvements in exercise capacity and patient-reported outcomes suggest a potential for meaningful improvements in quality of life for these individuals.
The IMPROVE-DiCE Phase 2 trial showed a statistically significant increase in the cardiac phosphocreatine to adenosine triphosphate (PCr/ATP) ratio, indicating improved cardiac energy reserves. The trial also demonstrated increased left ventricular systolic reserve capacity during exercise, better 6-minute walk distance, and clinically meaningful enhancements in heart failure-related health status, particularly in patients with more severe symptoms at baseline. These results build upon prior positive findings in pre-HFpEF patients.
These positive Phase 2 results provide a strong foundation for further development of ninerafaxstat in HFpEF and related conditions like non-obstructive hypertrophic cardiomyopathy (nHCM). The findings suggest the potential for a new treatment option that directly addresses the underlying energetic deficiencies driving this prevalent form of heart failure. Future research will focus on confirming these findings in larger, later-stage clinical trials and further characterizing the drug’s benefit in specific patient subpopulations. This advancement holds promise for improving the lives of millions affected by HFpEF.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
