Pemvidutide showed a “highly statistically significant” treatment effect in patients with alcohol use disorder. Altimmune is going up against Eli Lilly and newcomer Baseline Therapeutics, among others, in this space.
Altimmune’s investigational GLP-1/GIP injection met the primary and key secondary endpoints in a mid-stage trial involving patients with alcohol use disorder.
In the Phase 2 RECLAIM study, Altimmune enrolled 100 patients who were randomly assigned to receive the experimental therapy, dubbed pemvidutide, or placebo. Topline results revealed Tuesday showed that participants on pemvidutide had 4.20 fewer heavy drinking days—defined as having five drinks for men and four for women—per week, on average, at 24 weeks versus baseline.
Meanwhile, in the placebo group, heavy drinking days decreased by 2.75 days per week on average over the same time period. The treatment effect was “highly statistically significant” in favor of pemvidutide, Altimmune said in its press release.
The FDA validated a two-level reduction in World Health Organization risk drinking levels (WHO-RDL) as an accepted endpoint last year.
A two-level reduction in WHO-RDL “provides a new endpoint option for researchers and drug developers alongside abstinence and no heavy drinking days,” according to the FDA, Truist Securities said in a note to investors on Tuesday.
Altimmune shares jumped as much as 19% to $3.51 in premarket trading.
Pemvidutide also aced key secondary trial endpoints, including 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, a biomarker of alcohol intake. A “generally favorable” tolerability profile was observed.
Altimmune is “extremely encouraged” by these findings, Chief Medical Officer Christophe Arbet-Engels said in a prepared statement.
With these data in hand, the biotech will request an end-of-Phase 2 meeting with the FDA to determine the path forward for pemvidutide in this indication. RECLAIM’s results will also be presented at an upcoming scientific congress and will be filed for publication in a peer-reviewed journal.
Designed as a weekly under-the-skin injection, pemvidutide is a dual agonist of the GLP-1 and GIP receptors—a targeting profile that Arbet-Engels said could set the drug apart in the alcohol use disorder (AUD) arena.
“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,” he said on Tuesday.
Truist appeared to agree.
“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,” the analysts wrote.
Aside from AUD, Altimmune is also advancing pemvidutide for metabolic dysfunction-associated steatohepatitis. In a Phase 2b study, the candidate elicited significantly improved disease resolution versus placebo, the biotech reported in November 2025. The findings point to “class-leading signals” for pemvidutide, H.C. Wainwright said at the time, further predicting 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 class has shown potential in a wide variety of therapeutic spaces, including neurodegenerative diseases and some obesity-associated cancers.
AUD appears to be of particular interest for biopharma. Eli Lilly, a frontrunner in this drug class, has two Phase 3 trials underway in AUD for its investigational GLP-1/GIP asset brenipatide—one focusing on patients with moderate-to-severe disorder, and another that does not list this enrolment restriction. Joining Lilly is Baseline Therapeutics, which launched in January to advance a weekly GLP-1 drug for AUD, with plans to push into late-stage development this year.
Editor’s note (July 28): This article has been updated to include comments from Truist Securities.
