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Altimmune, Inc. (NASDAQ:ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today 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.
RESTORE (NCT07009860) is a randomized, placebo-controlled trial enrolling approximately 100 patients across 34 sites, with Dr. Rohit Loomba, Professor of Medicine, Chief of the Division of Gastroenterology and Hepatology, and Director of the MASLD Research Center at the University of California, San Diego, serving as the principal investigator. Patients will be randomized 1:1 to 2.4mg pemvidutide or placebo for 48 weeks. The primary endpoint of the trial is the change from baseline in liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) at Week 24. 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.
Posted In: ALT
