Altimmune Begins Phase 2 Trial of Pemvidutide for Alcohol Use Disorder

Altimmune, Inc., a biopharmaceutical company based in Gaithersburg, Maryland, has taken a significant step in developing treatments for liver and cardiometabolic diseases. The company has initiated the RECLAIM Phase 2 trial to assess the effectiveness and safety of pemvidutide in treating Alcohol Use Disorder (AUD). Pemvidutide is a groundbreaking dual receptor agonist targeting GLP-1/glucagon pathways and is under investigation for conditions such as metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD, and alcohol liver disease (ALD).

The RECLAIM trial is a randomized, placebo-controlled study that will be conducted at roughly 15 different sites across the United States. Dr. Henry Kranzler, a distinguished professor of psychiatry and lead researcher at the University of Pennsylvania’s Center for Studies of Addiction, is the principal investigator of the study. The trial aims to enroll about 100 participants, who will be randomly assigned to receive either 2.4 mg of pemvidutide or a placebo weekly over 24 weeks. The main goal of the trial is to measure changes in alcohol consumption, specifically looking at the variation from the baseline in the average number of heavy drinking days per week by the end of 24 weeks. Secondary objectives include the percentage of participants who achieve a two-level reduction in the World Health Organization's risk drinking levels and the absolute change in baseline phosphatidylethanol (PEth) levels, a marker of alcohol intake.

The investigational new drug application for pemvidutide in treating AUD was submitted in December 2024 and received clearance from the FDA in January 2025. Dr. Kranzler emphasized the urgent need for effective AUD treatments, noting that over 28 million people in the U.S. suffer from this disorder, yet only a small fraction receive treatment. Currently approved treatments are limited in effectiveness and compliance, creating a significant treatment gap.

Dr. Scott Harris, Chief Medical Officer of Altimmune, highlighted that GLP-1 agents have shown promise in reducing alcohol craving, alongside their known effects on food consumption. In preclinical models, pemvidutide demonstrated a substantial reduction in alcohol preference, indicating its potential as an effective treatment. Additionally, since AUD often precedes alcohol liver disease (ALD) and shares risk factors with obesity, successfully addressing AUD with pemvidutide could also mitigate related metabolic disorders.

Altimmune is committed to developing innovative peptide-based therapeutics aimed at tackling liver and cardiometabolic diseases. Their leading program, pemvidutide, is a GLP-1/glucagon dual receptor agonist designed to address multiple conditions, including MASH, obesity, and AUD.

With the ongoing trials and promising data, Altimmune aims to fill the significant treatment gap in AUD and related conditions, offering hope for new, more effective therapies. The company continues to advance in its mission to provide innovative solutions for complex health challenges, demonstrating the potential of peptide-based therapeutics in transforming treatment landscapes.