Altimmune Announces Initiation of RESTORE Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol-Associated Liver Disease (ALD)

Core Insights - Altimmune, Inc. has initiated the RESTORE Phase 2 trial for pemvidutide, targeting Alcohol-Associated Liver Disease (ALD) [1][2] - Pemvidutide is a dual receptor agonist aimed at treating various liver and cardiometabolic diseases, including Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Alcohol Use Disorder (AUD) [1][4] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases [5] - The lead program, pemvidutide, is designed to address MASH, AUD, ALD, and obesity [5] Clinical Trial Details - The RESTORE trial will enroll approximately 100 patients across 34 sites, with a 1:1 randomization to receive either 2.4mg pemvidutide or placebo for 48 weeks [2] - The primary endpoint is the change in liver stiffness measurement (LSM) at Week 24, with key secondary endpoints including changes in LSM at Week 48 and alcohol consumption [2] Pemvidutide Efficacy - Previous trials, including the IMPACT Phase 2b trial, demonstrated significant reductions in liver fat, body weight, and liver stiffness, supporting the potential efficacy of pemvidutide [3][4] - Pemvidutide has shown class-leading tolerability with low rates of discontinuation due to adverse events [4] Market Need - There are currently no approved treatments for ALD, and over 6 million Americans with Alcohol Use Disorder have progressed to this condition, highlighting the urgent need for effective therapies [3]