Altimmune Reports Positive Pemvidutide Alcohol-Use Trial Results
Pemvidutide cut heavy drinking by a placebo-adjusted 1.45 days a week at 24 weeks.
Altimmune (ALT), a clinical-stage biopharmaceutical company, reported that pemvidutide met key alcohol-use endpoints in its Phase 2 RECLAIM trial, advancing the obesity drug candidate as a potential treatment for alcohol use disorder.
The positive topline results arrived ahead of Altimmune’s previously anticipated third-quarter 2026 readout and shifted the program toward discussions with regulators about a registrational path.
Patients receiving pemvidutide reduced heavy drinking days by an LS mean 4.20 days a week from baseline, compared with 2.75 days for placebo, at Week 24. The difference was statistically significant at p=0.0014. Pemvidutide also produced a two-level reduction in the World Health Organization’s Risk Drinking Level in 64.4% of patients, compared with 34.8% on placebo.
Abstinence measures supported the primary finding. During Weeks 21 through 24, 42.2% of pemvidutide patients recorded zero heavy drinking days, versus 17.4% of placebo patients. Days with abstinence increased 38.9% from baseline with pemvidutide and 20.5% with placebo, while the PEth alcohol-use biomarker fell by an LS mean 153.4 in the treatment group and rose 22.0 in the placebo group.
Pemvidutide also delivered 9.1% placebo-adjusted weight loss at 24 weeks without evidence of plateauing. That exceeded the 7.5% weight loss recorded at 48 weeks with the 1.8-milligram dose in the earlier IMPACT MASH trial, where placebo patients lost 0.2%.
Gastrointestinal side effects were more common with pemvidutide, including nausea in 44% of patients and vomiting in 18%, compared with 24% and 6% for placebo, respectively. Overall discontinuation rates were similar at 20% for pemvidutide and 22% for placebo, though drug-related adverse events led 10% of treated patients to discontinue, compared with none in the placebo group. Serious adverse events occurred in 4% of pemvidutide patients versus 2% on placebo, and one case of hyponatremia was considered possibly treatment-related.
Altimmune now plans to request an End-of-Phase 2 meeting with the Food and Drug Administration to discuss pemvidutide’s development path in alcohol use disorder. The company also introduced a two-step titration schedule for the 2.4-milligram dose, which may improve gastrointestinal tolerability.