Altimmune reports positive Phase 2 RECLAIM topline results for pemvidutide in AUD

Altimmune announced positive topline Phase 2 results for pemvidutide 2.4 mg showing a significant reduction in heavy drinking days versus placebo.

Key Highlights:

• RECLAIM met its primary endpoint: pemvidutide reduced heavy drinking days/week vs placebo by 1.45 days (p=0.0014).
• Two FDA-recognized registrational secondary endpoints met: 2-level WHO risk reduction (64.4% vs 34.8%, p=0.0049) and zero HDD (42.2% vs 17.4%, p=0.0066).
• Significant biomarker and abstinence effects: PEth reduced (LS mean diff -175.3, p<0.0001); percent days abstinent up 18.4% (p=0.0075).
• Generally favorable tolerability; more GI AEs with pemvidutide (nausea 44%, vomiting 18%) and 10% had drug-related discontinuations.
• Company plans to request an End-of-Phase 2 meeting with the FDA and will submit data for conference presentation and publication.

Original SEC Filing:

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