Altimmune Enrolls First Patient in Restore Phase 2 Trial for Alcohol-Associated Liver Disease Treatment

Altimmune has enrolled the first patient in the Restore Phase 2 trial evaluating pemvidutide for the treatment of Alcohol-Associated Liver Disease (ALD). The trial will enroll approximately 100 patients across 34 sites and assess the efficacy and safety of pemvidutide over 48 weeks. The primary endpoint is the change in liver stiffness measurement by vibration-controlled transient elastography at Week 24.

Altimmune, Inc. (Nasdaq: ALT) has enrolled the first patient in the RESTORE Phase 2 trial evaluating pemvidutide for the treatment of Alcohol-Associated Liver Disease (ALD). The trial, which aims to enroll approximately 100 patients across 34 sites, will assess the efficacy and safety of pemvidutide over 48 weeks. The primary endpoint is the change in liver stiffness measurement by vibration-controlled transient elastography (VCTE) at Week 24 [1].

Pemvidutide, a novel investigational GLP-1/glucagon dual receptor agonist, is being developed for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), ALD, and obesity. The RESTORE trial follows FDA clearance of the Investigational New Drug (IND) application for pemvidutide in ALD in January 2025 [1].

The RESTORE trial is led by 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. Patients will be randomized 1:1 to receive either 2.4mg pemvidutide or placebo for 48 weeks [1].

The trial's primary endpoint is the change from baseline in liver stiffness measurement (LSM) by 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 [1].

The RESTORE trial builds on the encouraging data from the IMPACT Phase 2b MASH trial, where pemvidutide demonstrated statistically significant reductions in VCTE, liver fat, and markers of fibrosis and inflammation at 24 weeks [1]. The trial's robust design and the involvement of Dr. Loomba, a recognized expert in liver disease, add credibility to this clinical program.

Altimmune's expansion of pemvidutide into ALD represents strategic pipeline growth targeting a large unmet medical need with encouraging preliminary data. The company's initiation of the RESTORE Phase 2 trial for pemvidutide in ALD underscores its commitment to addressing significant medical needs with innovative therapies [2].

References:
[1] https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-initiation-restore-phase-2-trial-evaluating
[2] https://www.stocktitan.net/news/ALT/altimmune-announces-initiation-of-restore-phase-2-trial-evaluating-6iqauh4ylo0m.html