Altimmune Inc. reported positive topline findings from its RECLAIM Phase 2 study of pemvidutide in alcohol use disorder, a disclosure that coincided with an 18% rise in the company's shares on Tuesday. The results showed the trial reached its primary endpoint, with the active treatment producing a statistically significant reduction in heavy drinking days compared with placebo.
At the 2.4 mg dose, pemvidutide reduced heavy drinking days by 4.20 days per week from baseline at week 24. Patients assigned to placebo experienced a reduction of 2.75 days, yielding a treatment effect of 1.45 days and a p-value of 0.0014.
In addition to the primary outcome, the study achieved important secondary endpoints that the U.S. Food and Drug Administration recognizes as potential registrational measures. These included a two-level reduction in World Health Organization (WHO) risk drinking levels and the achievement of zero heavy drinking days over the assessed interval.
Specifically, 64.4% of patients receiving pemvidutide attained a two-level reduction in WHO Risk Drinking Levels versus 34.8% of those on placebo, with a reported p-value of 0.0049. For the zero heavy drinking days endpoint, 42.2% of patients in the pemvidutide arm reached zero heavy drinking days during weeks 21 through 24, compared with 17.4% in the placebo group.
The trial enrolled a total of 100 patients, evenly randomized with 50 receiving pemvidutide 2.4 mg and 50 receiving placebo. The company described the investigational compound as a balanced glucagon/GLP-1 dual receptor agonist being evaluated for moderate to severe alcohol use disorder.
Safety and tolerability were reported as generally acceptable, with most adverse events graded mild to moderate. Nausea was reported in 44% of patients on pemvidutide versus 24% on placebo, while vomiting occurred in 18% of treated patients compared with 6% of those on placebo. Treatment discontinuations were 20% for the pemvidutide group and 22% for placebo overall, and 10% of pemvidutide-treated patients discontinued due to study drug-related adverse events.
Following the topline readout, Altimmune said it intends to request an End-of-Phase 2 meeting with the FDA to discuss the development path for pemvidutide in alcohol use disorder.
Summary
Altimmune's RECLAIM Phase 2 trial showed a statistically significant reduction in heavy drinking days at week 24 for pemvidutide 2.4 mg versus placebo and met secondary endpoints recognized by the FDA. The 100-patient study reported generally manageable adverse events and set the stage for a planned End-of-Phase 2 meeting with the FDA.
Key points
- RECLAIM Phase 2 met its primary endpoint: pemvidutide 2.4 mg reduced heavy drinking days by 4.20 days from baseline at week 24 versus 2.75 days for placebo (treatment effect 1.45 days; p = 0.0014).
- Secondary endpoints achieved include a two-level reduction in WHO Risk Drinking Levels (64.4% treatment vs 34.8% placebo; p = 0.0049) and zero heavy drinking days in weeks 21-24 (42.2% treatment vs 17.4% placebo).
- The company will request an End-of-Phase 2 meeting with the FDA to discuss the next regulatory steps for pemvidutide.
Risks and uncertainties
- Adverse events were common: nausea affected 44% of pemvidutide patients versus 24% on placebo, and vomiting occurred in 18% versus 6%, which may influence tolerability assessments.
- Treatment discontinuations occurred in 20% of the pemvidutide group, with 10% discontinuing due to study drug-related adverse events; discontinuation rates could affect future trial retention and outcomes.
- The RECLAIM study enrolled 100 patients, a relatively small sample size; further data and regulatory discussions with the FDA are required to determine the path forward.