Altimmune (ALT) Study result summary

Study design and patient population

• Phase II RECLAIM trial evaluated pemvidutide, a dual glucagon/GLP-1 receptor agonist, in 100 adults with moderate to severe alcohol use disorder (AUD), randomized 1:1 to 2.4 mg pemvidutide or placebo weekly for 24 weeks, with behavioral intervention.

• Key eligibility included moderate-to-severe AUD, heavy drinking, BMI ≥ 25 kg/m², and treatment-seeking; baseline demographics were balanced, with 52% female and average age of 50.

• The study included a diverse, real-world U.S. population, with 20-30% at higher risk for cirrhosis based on FIB-4 scores.

• Retention was high, with 91% completing the study; 80% in pemvidutide and 78% in placebo arms completed treatment.

• Six placebo patients discontinued due to lack of efficacy, compared to none in the pemvidutide arm.

Efficacy results

• Pemvidutide achieved a statistically significant reduction in heavy drinking days versus placebo at week 24 (difference of 1.45 days, p=0.0014).

• 64.4% of pemvidutide patients achieved a 2-level reduction in WHO Risk Drinking Levels versus 34.8% on placebo (p=0.0049).

• 42.2% of pemvidutide patients had zero heavy drinking days in weeks 21–24 versus 17.4% for placebo (p=0.0066).

• Significant increase in percent days with abstinence (difference of 18.4%–38.9% vs 20.5%, p=0.0075).

• Statistically significant reduction in PEth levels (treatment difference: -175.3 ng/mL, p<0.0001) and 9.1% placebo-adjusted reduction in body weight at 24 weeks.

Safety and tolerability

• Pemvidutide was generally well tolerated; most adverse events were mild to moderate.

• GI-related adverse events (nausea 44%, vomiting 18%, diarrhea 20%, constipation 22%) were more frequent with pemvidutide but mostly mild to moderate.

• 10% of pemvidutide patients discontinued due to drug-related adverse events.

• Two serious adverse events occurred: one breast cancer, one hyponatremia; only the latter was possibly related to study drug.

• The two-step titration scheme may have improved GI tolerability at the higher dose.