Altimmune Reports Positive Phase 2 RECLAIM Trial Results for Pemvidutide in Alcohol Use Disorder

summarizeSummary

Altimmune announced positive topline results from its Phase 2 RECLAIM trial for pemvidutide in alcohol use disorder, meeting its primary endpoint and key secondary endpoints, which significantly advances the drug's development.

check_boxKey Events · Product Development and Regulatory · ALT

• Positive Phase 2 RECLAIM Trial Results

  Altimmune announced positive topline results from its RECLAIM Phase 2 trial evaluating pemvidutide 2.4 mg in patients with moderate to severe alcohol use disorder (AUD).

• Met Primary and Key Secondary Endpoints

  The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days per week versus placebo. Important secondary endpoints, including a two-level reduction in WHO Risk Drinking Level and zero heavy drinking days (both FDA registrational endpoints), were also met.

• Favorable Safety Profile

  A generally favorable safety and tolerability profile was observed for pemvidutide in the trial.

• Advancing to FDA Meeting

  The company plans to request an End-of-Phase 2 meeting with the FDA to discuss the path forward for pemvidutide in AUD, building on its existing Fast Track designation for this indication.

auto_awesomeAnalysis · ALT · Life Sciences

This filing announces highly positive topline results from the Phase 2 RECLAIM trial for pemvidutide in alcohol use disorder (AUD). Meeting the primary endpoint with statistical significance and showing positive results on FDA-recognized registrational secondary endpoints is a strong indicator of the drug's potential efficacy. Given the significant unmet need in AUD and pemvidutide's existing Fast Track designation for this indication, these results substantially strengthen Altimmune's pipeline and de-risk its lead candidate. The company's plan to request an End-of-Phase 2 meeting with the FDA signals progression towards a potential Phase 3 trial.