Altimmune's Pemvidutide Receives FDA Fast Track Status for Alcohol Use Disorder Treatment

Altimmune's GLP-1/glucagon dual receptor agonist, pemvidutide, has been granted fast track status by the US FDA for treating alcohol use disorder. Fast-track designation allows for a faster development and review timeline for drugs targeting serious conditions.

Altimmune (NASDAQ:ALT) has received a significant regulatory milestone from the U.S. Food and Drug Administration (FDA), with Fast Track designation for pemvidutide in the treatment of Alcohol Use Disorder (AUD). This designation, which aims to accelerate the development and review of drugs targeting serious conditions, underscores the potential of pemvidutide to address a critical unmet medical need.

The Fast Track designation is granted to drugs that show promise in treating serious or life-threatening conditions and demonstrate the potential to address a major unmet medical need. For pemvidutide, this designation means that the drug will benefit from enhanced communication with the FDA, potential rolling submission, and priority review of a New Drug Application (NDA), which can significantly accelerate the development timeline.

Pemvidutide is a novel, investigational, peptide-based 1:1 GLP-1/glucagon dual receptor agonist in development for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH), AUD, Alcohol-Associated Liver Disease (ALD), and obesity. The dual mechanism of action—combining GLP-1 agonism to reduce alcohol cravings and glucagon activity to address hepatic steatosis and inflammation—provides a differentiated approach to AUD treatment.

The ongoing RECLAIM Phase 2 trial (NCT06987513) is enrolling approximately 100 patients to evaluate the safety and efficacy of pemvidutide in AUD. The trial, which began in May 2025, will randomize patients 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks. The primary endpoint focuses on reducing heavy drinking days, with secondary endpoints including WHO risk drinking level reduction and changes in alcohol intake biomarkers.

The market opportunity for AUD treatment is substantial, with over 28 million adults in the U.S. suffering from the condition, yet only 2% receiving medication. This treatment gap represents both an unmet medical need and a commercial opportunity. The scientific rationale for pemvidutide in AUD is compelling, with preclinical studies showing significant reduction in alcohol intake.

Altimmune, a late clinical-stage biopharmaceutical company, is focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The company's lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist for the treatment of MASH, AUD, ALD, and obesity.

References:
[1] https://www.stocktitan.net/news/ALT/altimmune-announces-fda-fast-track-designation-for-pemvidutide-in-zkb42azg36ea.html