Altimmune announced on July 28 that its investigational GLP-1/GIP injection, pemvidutide, met the primary and key secondary endpoints in a mid-stage clinical trial for patients with alcohol use disorder.
In the Phase 2 RECLAIM study, 100 patients were randomly assigned to receive either pemvidutide or a placebo. According to topline results released Tuesday, participants who received pemvidutide had an average of 4.20 fewer heavy drinking days per week at 24 weeks compared to baseline. In comparison, those on placebo experienced a reduction of 2.75 days per week over the same period. Altimmune said the treatment effect was “highly statistically significant” in favor of pemvidutide.
The U.S. Food and Drug Administration validated a two-level reduction in World Health Organization risk drinking levels as an accepted endpoint last year. Truist Securities said in a note to investors that this provides “a new endpoint option for researchers and drug developers alongside abstinence and no heavy drinking days.”
Pemvidutide also achieved key secondary endpoints, including increasing the proportion of patients with zero heavy drinking days during the final weeks of the study, raising percentages of alcohol abstinence days, and lowering serum phosphatidyl ethanol levels—a biomarker for alcohol intake. The therapy showed what Altimmune described as a “generally favorable” tolerability profile.
Chief Medical Officer Christophe Arbet-Engels said Altimmune is “extremely encouraged” by these findings. He added that given “the known detrimental effects of alcohol on the liver,” pemvidutide’s liver-directed impact may provide additional benefit over GLP-1 alone in treating alcohol use disorder.
With these results, Altimmune plans to request an end-of-Phase 2 meeting with the FDA to discuss next steps for developing pemvidutide for this indication. The company also intends to present RECLAIM’s data at an upcoming scientific congress and submit them for publication.
