Altimmune Inc. (NASDAQ:ALT) shares climbed 18% on Tuesday after the biotechnology company reported positive topline data from its Phase 2 RECLAIM study evaluating pemvidutide as a treatment for alcohol use disorder.
The trial successfully achieved its primary endpoint, demonstrating a statistically significant reduction in heavy drinking days compared with placebo.
Pemvidutide Meets Primary and Secondary Trial Endpoints
Patients treated with pemvidutide 2.4 mg reduced heavy drinking days by an average of 4.20 days per week from baseline after 24 weeks, compared with a reduction of 2.75 days in the placebo group. The treatment produced a difference of 1.45 days versus placebo, with a p-value of 0.0014.
The study also met key secondary endpoints recognised by the U.S. Food and Drug Administration as potential registrational measures.
Among patients receiving pemvidutide, 64.4% achieved a two-level reduction in World Health Organization (WHO) Risk Drinking Levels, compared with 34.8% in the placebo group, producing a p-value of 0.0049.
In addition, 42.2% of participants treated with pemvidutide recorded zero heavy drinking days between weeks 21 and 24 of the study, compared with 17.4% of those receiving placebo.
Safety Profile Supports Further Development
Pemvidutide is an investigational dual glucagon and GLP-1 receptor agonist currently being developed as a treatment for moderate to severe alcohol use disorder.
The RECLAIM study enrolled 100 patients, with 50 participants receiving pemvidutide 2.4 mg and the remaining 50 receiving placebo.
The treatment was generally well tolerated, with most adverse events reported as mild to moderate.
Nausea was experienced by 44% of patients receiving pemvidutide, compared with 24% in the placebo group, while vomiting occurred in 18% and 6% of patients, respectively.
Overall treatment discontinuation rates were comparable between the two groups, at 20% for pemvidutide and 22% for placebo. Around 10% of patients in the treatment arm discontinued because of study drug-related adverse events.
Company Plans FDA Meeting
Following the positive Phase 2 results, Altimmune said it intends to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration to discuss the next stage of clinical development for pemvidutide in alcohol use disorder.