Altimmune, Inc. announced positive topline results from its Phase 2b IMPACT trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH). The trial, involving 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3, met its primary endpoint of MASH resolution without fibrosis worsening in a significant percentage of participants receiving pemvidutide. The results also showed promising weight loss and a favorable safety profile.
This positive data is crucial for the MASH treatment landscape, which currently lacks effective therapies for this prevalent and progressive liver disease. With a projected 27 million MASH patients in the US by 2030, pemvidutide’s efficacy and safety profile position it as a potential game-changer for patients facing this serious condition. The results offer hope for a treatment that addresses both the underlying liver disease and the associated metabolic issues, significantly improving patients’ quality of life.
In the 24-week study, both the 1.2 mg and 1.8 mg weekly doses of pemvidutide showed statistically significant MASH resolution without fibrosis worsening compared to placebo (59.1% and 52.1% vs. 19.1%, respectively). While fibrosis improvement without MASH worsening was observed (31.8% and 34.5% vs. 25.9%), the difference wasn’t statistically significant. An AI-based analysis, however, did reveal statistically significant fibrosis reductions, with 30.6% of participants on the 1.8 mg dose achieving a 60% or greater reduction. Furthermore, significant weight loss was observed in both pemvidutide groups (5.0% and 6.2%) compared to placebo (1.0%). Importantly, pemvidutide demonstrated excellent tolerability, with less than 1% treatment discontinuation due to adverse events in the pemvidutide groups.
The positive Phase 2b results pave the way for Altimmune to engage with the FDA in an End-of-Phase 2 meeting. This interaction will be crucial for defining the path forward, including the design and scope of a Phase 3 trial. The strong efficacy and safety data, combined with the unmet medical need in MASH, suggest a high probability of advancing pemvidutide to the next stage of clinical development. This progress could represent a significant step towards bringing a much-needed treatment option to MASH patients and significantly impacting the liver disease therapeutic area.
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.
