Altimmune (Nasdaq: ALT) shows efficacy in Phase 2 pemvidutide AUD trial
Rhea-AI Filing Summary
Altimmune reported positive topline Phase 2 results for once-weekly pemvidutide 2.4 mg in patients with moderate to severe alcohol use disorder. The study met its primary endpoint with a highly statistically significant reduction in heavy drinking days per week versus placebo and achieved multiple secondary endpoints, including a two-level reduction in World Health Organization Risk Drinking Levels, zero heavy drinking days and reductions in phosphatidyl ethanol, an objective biomarker of alcohol intake; the first two are recognized by the FDA as registrational endpoints.
Pemvidutide showed a generally favorable safety and tolerability profile, with gastrointestinal adverse events such as nausea, vomiting, diarrhea and constipation more frequent than placebo but mostly mild to moderate in severity, and similar overall treatment discontinuation rates between arms. Altimmune plans to request an End-of-Phase 2 meeting with the FDA, submit the results for scientific presentation and publication, and continue developing pemvidutide across alcohol use disorder and serious liver diseases.
Positive
- Pemvidutide met the Phase 2 primary endpoint, reducing heavy drinking days per week versus placebo with a least-squares mean difference of -1.45 and p=0.0014, indicating strong statistical evidence of efficacy in alcohol use disorder.
- Key FDA-recognized secondary endpoints were achieved: a two-level WHO Risk Drinking Level reduction in 64.4% of pemvidutide patients vs 34.8% on placebo and zero heavy drinking days in 42.2% vs 17.4%, with supportive biomarker (PEth) improvements.
Negative
- None.
Filing Explained
The stated treatment effect was 1.45 fewer heavy-drinking days per week, while drug-related discontinuation occurred in 10% of pemvidutide patients.
On
The study randomized approximately 100 patients 1:1 to weekly pemvidutide 2.4 mg or placebo for 24 weeks. At Week 24, the reported change in heavy drinking days per week was -4.20 with pemvidutide versus -2.75 with placebo, with a stated treatment effect of -1.45. The two-level reduction in WHO risk drinking level occurred in
Gastrointestinal events were more frequent with pemvidutide, including nausea at
8-K Event Classification
Key Figures
Key Terms
heavy drinking days (HDD) medical
World Health Organization Risk Drinking Levels medical
phosphatidyl ethanol (PEth) medical
End-of-Phase 2 meeting regulatory
Fast Track designations regulatory
Breakthrough Therapy Designation regulatory
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