Altimmune Initiates RESTORE Phase 2 Trial for Pemvidutide in Alcohol-Associated Liver Disease (ALD)

Altimmune has initiated the RESTORE Phase 2 trial to evaluate the efficacy and safety of pemvidutide in treating Alcohol-Associated Liver Disease (ALD). The trial will involve approximately 100 patients and target a significant unmet medical need, as over 6 million Americans with Alcohol Use Disorder have progressed to ALD. Pemvidutide is a GLP-1/glucagon dual receptor agonist with promising data in treating Metabolic Dysfunction-Associated Steatohepatitis (MASH).

Altimmune, Inc. (Nasdaq: ALT) has enrolled the first patient in its RESTORE Phase 2 trial, which aims to evaluate the efficacy and safety of pemvidutide in treating Alcohol-Associated Liver Disease (ALD). The trial, which is enrolling approximately 100 patients across 34 sites, is led by Dr. Rohit Loomba, Professor of Medicine and Chief of the Division of Gastroenterology and Hepatology at the University of California, San Diego. The RESTORE trial will assess changes in liver stiffness measurement (LSM) by vibration-controlled transient elastography (VCTE) at Weeks 24 and 48, as well as other health metrics such as Enhanced Liver Fibrosis (ELF) score and alcohol consumption and body weight changes [1].

Pemvidutide, an investigational GLP-1/glucagon dual receptor agonist, has shown promising results in earlier trials, including the IMPACT Phase 2b MASH trial. In the IMPACT trial, pemvidutide demonstrated statistically significant reductions in liver fat, weight loss, and improvements in blood pressure, as well as a statistically significant reduction in liver fibrosis [1]. The RESTORE trial follows the successful completion of the MOMENTUM Phase 2 obesity trial and the ongoing IMPACT Phase 2b MASH trial, which is expected to report its 48-week readout in Q4 2025 [1].

The RESTORE trial addresses a critical unmet medical need, as over 6 million Americans with Alcohol Use Disorder have progressed to ALD, a condition for which there are no approved treatments [1]. The U.S. FDA granted pemvidutide Fast Track designation for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), highlighting its potential significance in treating this condition [1].

Altimmune's Chief Medical Officer, Scott Harris, M.D., expressed enthusiasm about the RESTORE trial, stating, "We believe that the statistically significant reductions in VCTE, liver fat and markers of fibrosis and inflammation in the recent IMPACT trial at 24 weeks position pemvidutide for a positive efficacy readthrough in the RESTORE trial" [1].

The RESTORE trial is part of Altimmune's broader effort to develop novel peptide-based therapeutics for liver and cardiometabolic diseases. The company's lead program, pemvidutide, is in late clinical development for the treatment of MASH, AUD, ALD, and obesity [1].

While the RESTORE trial marks a significant step forward in the development of pemvidutide for ALD, it is important to note that pemvidutide is still investigational and has not yet received regulatory approval for the treatment of ALD or any of the conditions it targets [1]. The trial is in a late clinical stage, indicating a high level of urgency and pressure on the company's ability to deliver effective results.

References:
[1] https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-initiation-restore-phase-2-trial-evaluating
[2] https://www.nasdaq.com/articles/altimmune-inc-enrolls-first-patient-restore-phase-2-trial-pemvidutide-alcohol-associated