Altimmune的pemvidutide在酒精使用障碍二期研究达到主要终点

Altimmune (ALT) shares rose more than 15% in the premarket on Tuesday after the company said that its GLP-1 candidate pemvidutide cut drinking in a mid-stage trial for patients with alcohol use disorder.
Based on topline data, the Gaithersburg, Maryland-headquartered biotech noted that pemvidutide, its lead asset, met the primary endpoint in its RECLAIM Phase 2 trial, resulting in a statistically significant reduction in heavy drinking days among patients with moderate to severe AUD.
The multicenter study enrolled roughly 100 patients with AUD who received either 2.4 mg of the dual glucagon-GLP-1 agonist or a placebo once weekly for 24 weeks.
According to the company, the results for key secondary endpoints, such as the World Health Organization (WHO) Risk Drinking Levels, were consistently positive, and the study drug demonstrated a generally favorable tolerability profile among trial subjects.
However, 20% of trial participants on pemvidutide dropped out, as 5% developed adverse events related to the study drug. The rate of trial discontinuations stood at 22% in the placebo arm. Based on RECLAIM data, Altimmune (ALT) plans to request an End-of-Phase 2 meeting with the FDA to determine the next steps for the program.