Altimmune announces FDA Fast Track designation for pemvidutide

Altimmune (ALT) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation to pemvidutide for the treatment of Alcohol Use Disorder, AUD. Fast Track designation is intended to accelerate the development and review of new drugs that target serious conditions and address unmet medical needs. RECLAIM, a Phase 2 trial evaluating the safety and efficacy of pemvidutide in AUD, is currently enrolling. Approximately 100 patients will be randomized 1:1 to receive either 2.4 mg pemvidutide or placebo once weekly for 24 weeks. The primary endpoint of the trial is the change from baseline in the average number of heavy drinking days, with key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization risk drinking level and absolute change from baseline in average levels of phosphatidylethanol, a serum biomarker of alcohol intake. The trial began enrolling in May 2025.