Pharmaceutical Business review

Imbria secures $57.5m to advance ninerafaxstat through Phase IIb nHCM trial

The therapy has demonstrated encouraging outcomes in Phase IIa trials for nHCM and heart failure with preserved ejection fraction. Credit: jesse orrico on Unsplash.

Spearheaded by Deep Track Capital, this funding round saw participation from new investors, including Catalio Capital Management, Cytokinetics, and AN Ventures, alongside contributions from current backers SV Health Investors and RA Capital Management.

The placebo-controlled, double blind, placebo-controlled, randomised trial is set to commence in the second quarter of this year, with expectations for topline data by late 2026.

Imbria noted that the therapy has demonstrated encouraging outcomes in multiple Phase IIa trials for nHCM and heart failure with preserved ejection fraction (HFpEF), under the IMPROVE-HCM and IMPROVE-DiCE trials, respectively.

The therapy is designed to address cardiac disorders characterised by an imbalance of energy supply and demand in the heart.

According to the company, this partial fatty acid oxidation (pFOX) inhibitor is an oral compound that promotes a shift in the heart’s preference from fatty acids to glucose, resulting in energy generation by the mitochondria.

This mechanism has the potential to enhance cardiac function at rest and during physical activity. Ninerafaxstat does not require dose titration or monitoring and has no significant drug-drug interactions, according to the company.

Concurrent to the funding round, the company announced that Dr Alvin Shih will be transitioning from executive chair to CEO of Imbria and will continue his role on the company’s board of directors.

Dr Shih said: “Ninerafaxstat’s unique mechanism of action, coupled with a strong efficacy and safety profile that has now been demonstrated in multiple clinical trials, positions it as a potential first-in-class therapy for a broad spectrum of cardiometabolic diseases with high unmet need.”

Additionally, the company welcomed Rebecca Luse, managing director of Deep Track Capital, to the board of directors.