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Biotechnology: Pharmaceutical Preparations
Clinical TrialJul 28, 2026, 07:07 AM

Altimmune's Pemvidutide Phase 2 AUD Trial Meets Primary Endpoint

AI Summary

Altimmune, Inc. announced positive topline results from its RECLAIM Phase 2 trial evaluating pemvidutide 2.4 mg for moderate to severe alcohol use disorder (AUD). The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days per week versus placebo. Key secondary endpoints, including a two-level reduction in WHO Risk Drinking Level and zero heavy drinking days (both FDA registrational endpoints), were also met. The company observed a generally favorable safety and tolerability profile and plans to request an End-of-Phase 2 meeting with the FDA.

Key Highlights

  • Pemvidutide 2.4 mg achieved a statistically significant reduction in heavy drinking days (HDD) per week (p=0.0014).
  • 64.4% of patients on pemvidutide achieved a two-level reduction in WHO Risk Drinking Levels (p=0.0049).
  • 42.2% of pemvidutide patients had zero heavy drinking days (p=0.0066).
  • Statistically significant increase in percent of days with abstinence (p=0.0075).
  • Statistically significant reduction in serum PEth levels (p<0.0001).
  • Generally favorable safety and tolerability profile observed.
  • Company plans to request an End-of-Phase 2 meeting with the FDA.