Altimmune, Inc. announced that it has enrolled the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist in development for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), ALD and obesity. Key secondary endpoints include the change from baseline in LSM by VCTE at Week 48, changes in Enhanced Liver Fibrosis (ELF) score at weeks 24 and 48, and changes in alcohol consumption and body weight at the same time points.
An investigational new drug (IND) application for pemvidutide in ALD was filed in December 2024 and cleared by FDA in January 2025. Pemvidutide was well tolerated in the IMPACT trial, demonstrating potentially best-in-class tolerability among drugs in development for MASH with very low rates of discontinuation due to adverse events. The U.S. FDA granted Fast Track designation to pemvidutide for the treatment of MASH.
The MOMENTUM Phase 2 obesity trial was completed in 2024 and the ongoing IMPACT Phase 2b MASH trial 48-week readout is expected in Fourth Quarter 2025. In addition, RECLAIM, a Phase 2 trial in AUD and RESTORE, a Phase 2 trial in ALD, were initiated in May 2025 and July 2025, respectively.
