Science
Phase 2 trial meets primary endpoint, significantly reducing heavy-drinking days Blood alcohol biomarker falls 38%; follow-up discussions with FDA planned

Altimmune’s next-generation GLP-1/glucagon dual agonist pemvidutide significantly reduced the number of heavy-drinking days among patients with alcohol use disorder (AUD), achieving positive results in a phase 2 trial.
On the 28th, local time, U.S. biotechnology company Altimmune announced positive topline results from the phase 2 trial of pemvidutide in alcohol use disorder, known as the Reclaim study. According to Fierce Biotech, the results raise expectations that GLP-1-class drugs, widely known as obesity treatments, could also be used effectively to treat alcohol use disorder.
In the 24-week trial, the group receiving pemvidutide experienced an average reduction of 4.2 days in heavy drinking from baseline. The placebo group, by contrast, saw a reduction of 2.75 days, meaning pemvidutide met the primary endpoint with statistical significance.
Pemvidutide also outperformed placebo on key secondary endpoints. A higher proportion of patients achieved a reduction of at least two levels in the World Health Organization’s hazardous drinking score, and the duration of abstinence also increased. In particular, pemvidutide sharply reduced levels of phosphatidylethanol (PEth), a blood biomarker of heavy drinking, by 38%, clearly differing from the placebo group, which showed a 5.9% increase.
Analysts at William Blair said in a report that “pemvidutide demonstrated clear clinical benefit in alcohol use disorder.” They analyzed that “the reduction in blood phosphatidylethanol levels, in particular, is the strongest indicator of pemvidutide’s efficacy in this indication.”
The safety profile observed in the trial was consistent with previous pemvidutide studies. Most adverse events were gastrointestinal problems commonly associated with GLP-1-class drugs. Five patients discontinued pemvidutide because of vomiting, constipation, fatigue and other issues, while there were no discontinuations in the placebo group.
Christophe Arbet-Engels, Altimmune’s chief medical officer (CMO), emphasized that “pemvidutide’s dual mechanism of action is a differentiator.” He explained that “given alcohol’s harmful effects on the liver, pemvidutide’s glucagon activity directly affects the liver and could provide additional benefits over GLP-1-only agents.” Novo Nordisk’s semaglutide and Eli Lilly’s GLP-1/GIP dual agonist retatrutide are currently being developed for alcohol use disorder.
Based on these results, Altimmune plans to meet with the U.S. Food and Drug Administration (FDA) to discuss its future development path. The company also plans to initiate a phase 3 trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) later this year. Meanwhile, William Blair expects Altimmune will need additional funding to conduct a pivotal trial for alcohol use disorder. The company had $535 million in cash and cash equivalents as of April 30, equivalent to approximately 802.5 billion won.

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