Altimmune Stock Surges on Positive Phase 2 Data for Alcohol Use Disorder Drug

Altimmune Inc. (NASDAQ:ALT) shares surged 18% in Tuesday trading after the biopharmaceutical company announced positive topline results from its RECLAIM Phase 2 trial of pemvidutide, an investigational treatment for moderate to severe alcohol use disorder.

Key Trial Endpoints Met

The company reported that the trial successfully met its primary endpoint, demonstrating a statistically significant reduction in heavy drinking days compared to a placebo. According to the announcement, patients receiving a 2.4 mg dose of pemvidutide experienced a reduction of 4.20 heavy drinking days per week from their baseline at week 24.

Key results from the trial include:

• The placebo group saw a reduction of 2.75 days, resulting in a treatment effect of 1.45 fewer heavy drinking days for the pemvidutide group (p-value of 0.0014).
• The trial also met crucial secondary endpoints, which the company noted are recognized by the FDA as registrational endpoints.
• 64.4% of patients on pemvidutide achieved a two-level reduction in WHO Risk Drinking Levels, compared to 34.8% in the placebo group.
• 42.2% of patients in the treatment group reported zero heavy drinking days in the final four weeks of the trial (weeks 21-24), versus 17.4% for placebo.

Ad

Safety Profile and Next Steps

Pemvidutide, an investigational glucagon/GLP-1 dual receptor agonist, was generally well tolerated in the 100-patient study. The company stated that most adverse events were mild to moderate in severity. Nausea was reported in 44% of pemvidutide patients compared to 24% on placebo, while vomiting occurred in 18% versus 6% for placebo.

Treatment discontinuation rates were similar between the two groups, with 20% for pemvidutide and 22% for placebo. Altimmune noted that 10% of patients in the pemvidutide arm discontinued treatment due to drug-related adverse events.

Following the positive data, Altimmune said it plans to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the clinical development path forward for pemvidutide in this indication. The successful trial results represent a significant milestone, potentially de-risking the asset for investors as it moves closer to a potential pivotal Phase 3 study.