Altimmune reported that its investigational GLP-1/GIP dual agonist pemvidutide met the primary and key secondary endpoints in a Phase 2 trial for alcohol use disorder. Patients receiving the drug had 4.20 fewer heavy drinking days per week at 24 weeks, compared to 2.75 fewer days for placebo.…
Altimmune announced on July 28, 2026 that its investigational GLP-1/GIP injection pemvidutide successfully met its primary and key secondary endpoints in a mid-stage study involving patients with alcohol use disorder AUD . The company reported that the treatment effect was "highly statistically significant" in favor of pemvidutide.
The Phase 2 RECLAIM study enrolled 100 patients who were randomly assigned to receive either pemvidutide or a placebo. Topline results released Tuesday showed that participants on pemvidutide experienced 4.20 fewer heavy drinking days per week on average at 24 weeks compared to baseline. Heavy drinking days were defined as five drinks for men and four drinks for women. In the placebo group, heavy drinking days decreased by 2.75 days per week on average over the same time period.
Altimmune shares surged as much as 19% to $3.51 in premarket trading following the data release. The company also reported that pemvidutide achieved a "generally favorable" tolerability profile throughout the study.
The U.S. Food and Drug Administration validated a two-level reduction in World Health Organization risk drinking levels WHO-RDL as an accepted endpoint last year. According to a note from Truist Securities to investors on Tuesday, the FDA stated that a two-level reduction in WHO-RDL "provides a new endpoint option for researchers and drug developers alongside abstinence and no heavy drinking days."
Pemvidutide also aced key secondary trial endpoints. These included the proportion of patients with zero heavy drinking days in the final weeks of the study, the percentage of days with alcohol abstinence, and serum phosphatidyl ethanol levels, which is a biomarker of alcohol intake.
Altimmune Chief Medical Officer Christophe Arbet-Engels said in a prepared statement that the company is "extremely encouraged" by these findings. With the data in hand, the biotech plans to request an end-of-Phase 2 meeting with the FDA to determine the path forward for pemvidutide in alcohol use disorder.
The results from the RECLAIM study will also be presented at an upcoming scientific congress and will be filed for publication in a peer-reviewed journal.
Pemvidutide is designed as a weekly under-the-skin injection and is a dual agonist of the GLP-1 and GIP receptors. Arbet-Engels said this targeting profile could set the drug apart in the AUD arena. He explained that "given the known detrimental effects of alcohol on the liver, the liver-directed impact of glucagon in pemvidutide may provide further benefit in the treatment of AUD over GLP-1 alone, underscoring pemvidutide's promising potential differentiation."
Truist Securities analysts appeared to agree with this assessment. In their note, they wrote: "We believe pemvi's dual MOA acting on the liver and addiction-suppression could make it effective in this AUD and alcohol-associated liver disease given that ~90% of people with AUD will develop liver steatosis, ~65% are overweight or have obesity, ~50% have hypertension and ~25% have hyperlipidemia."
Beyond AUD, Altimmune is also advancing pemvidutide for metabolic dysfunction-associated steatohepatitis MASH . In a Phase 2b study reported in November 2025, the candidate elicited significantly improved disease resolution compared to placebo. At that time, H.C. Wainwright analysts described the findings as "class-leading signals" for pemvidutide and predicted that Altimmune could see peak annual sales topping $1 billion in this indication.
While GLP-1 drugs are best known for their weight loss and glucose control benefits, the drug class has shown potential in a wide variety of therapeutic areas, including neurodegenerative diseases and some obesity-associated cancers.
Alcohol use disorder appears to be of particular interest for biopharma companies. Eli Lilly, a frontrunner in the GLP-1 drug class, has two Phase 3 trials underway in AUD for its investigational GLP-1/GIP asset brenipatide. One trial focuses on patients with moderate-to-severe disorder, while the other does not list this enrolment restriction. Joining Lilly is Baseline Therapeutics, which launched in January to advance a weekly GLP-1 drug for AUD and has plans to push into late-stage development this year.
The editor's note from July 28 indicates that this article has been updated to include comments from Truist Securities.
Peptides referenced: Pemvidutide, Glucagon, GLP-1.
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