Altimmune Reports Positive 48-Week Phase 2b Data For Pemvidutide In MASH

(RTTNews) - Altimmune, Inc. (ALT) on Friday reported positive topline results from the IMPACT Phase 2b trial of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH) at 48 weeks.

Topline data showed that pemvidutide achieved statistically significant improvements across treatment arms in key non-invasive tests, including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), compared with placebo. The company said the data showed continued reductions from week 24, indicating sustained antifibrotic activity at both dose levels.

Altimmune also reported additional weight loss at the 1.8 mg dose compared with the 24-week data, with no evidence of plateauing. The 48-week results maintained a favorable tolerability profile, including a lower discontinuation rate due to adverse events than placebo.

Additionally, the company said it has completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration and aligned on the design of a registrational Phase 3 trial in MASH patients with moderate to advanced liver fibrosis. Altimmune plans to initiate the Phase 3 program in 2026.