Altimmune Announces Topline 48-Week Data from IMPACT Phase 2b Trial

Altimmune, Inc. announced positive topline results from the 48-week IMPACT Phase 2b trial of pemvidutide, a glucagon/GLP-1 dual receptor agonist, for patients with metabolic dysfunction-associated steatohepatitis (MASH). The trial demonstrated statistically significant improvements in key non-invasive tests (NITs) for fibrosis, including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), compared to placebo. These improvements continued from the 24-week mark, indicating sustained antifibrotic activity. The 1.8 mg dose showed additional weight loss without plateauing and the drug maintained a favorable tolerability profile with a low discontinuation rate due to adverse events. Altimmune also held a productive End-of-Phase 2 meeting with the FDA, aligning on a pathway for a registrational Phase 3 trial in MASH patients with moderate to advanced liver fibrosis. The FDA indicated openness to incorporating the AIM-MASH AI Assist tool in the Phase 3 trial. Altimmune plans to evaluate multiple doses, including 2.4 mg, in the upcoming Phase 3 program, with scientific advice also being sought from European regulators.