Imbria Pharmaceuticals

About Imbria Pharmaceuticals

Imbria Pharmaceuticals is a privately held, clinical-stage biotechnology company founded in 2018, operating from Boston, Massachusetts. The company was co-founded by Andrew Levin and David-Alexandre C Gros. It directs its focus on developing therapies for cardiometabolic disorders by addressing fundamental impairments in cellular energy production. Imbria's business model centers on the research and development of its lead drug candidate, with its revenue stream contingent on successful clinical trials, regulatory approval, and eventual commercialization. The company's operations are supported by significant venture capital, having raised a total of $149 million over three funding rounds. A notable Series B round in March and April 2025, led by Deep Track Capital, secured $57.5-$59.2 million, with participation from investors like RA Capital Management, SV Health Investors, and Cytokinetics.

The company's key therapeutic asset is ninerafaxstat, an orally administered cardiac mitotrope. This drug candidate works as a partial fatty acid oxidation (pFOX) inhibitor. Its primary mechanism involves shifting the heart's energy metabolism from relying on fatty acid oxidation to glucose oxidation. This shift allows the heart's mitochondria to produce more energy (ATP) per unit of oxygen consumed, enhancing cardiac efficiency, especially when oxygen supply is limited. A key benefit of ninerafaxstat is its simple administration without the need for dose titration or monitoring, and it can be used alongside existing standard-of-care cardiovascular treatments.

Imbria's clinical development pipeline is strategically focused on ninerafaxstat for several indications where cellular energetic impairment is a key factor. The drug has completed multiple Phase 2a proof-of-concept trials. These trials have targeted non-obstructive hypertrophic cardiomyopathy (nHCM), heart failure with preserved ejection fraction (HFpEF), and stable angina. The IMPROVE-HCM trial for nHCM demonstrated that ninerafaxstat was safe, well-tolerated, and showed significant improvements in ventilatory efficiency and patient-reported outcomes. Similarly, the IMPROVE-DiCE trial for HFpEF showed positive effects on cardiac energetics, exercise capacity, and heart failure symptoms. Following these positive results, Imbria is advancing ninerafaxstat to a global Phase 2b trial, FORTITUDE-HCM, with initiation planned for the second quarter of 2025 and topline data anticipated in late 2026.