Pemvidutide - (RECLAIM)

July 28, 2026: Altimmune, Inc. (NASDAQ: ALT) reported positive topline results from the RECLAIM Phase 2 trial (NCT06987513) of pemvidutide 2.4 mg once weekly for 24 weeks in ~100 patients with moderate-to-severe alcohol use disorder (AUD) and BMI >25 kg/m². The study met its primary endpoint, showing a statistically significant reduction in heavy drinking days (HDD) per week at Week 24 vs placebo (LS mean change -4.20 vs -2.75; LS mean difference -1.45; p=0.0014).

Key secondary endpoints were also significant, including FDA-recognized registrational endpoints: 2-level reduction in WHO risk drinking levels (64.4% vs 34.8%; OR 3.31; p=0.0049) and zero HDD during Weeks 21–24 (42.2% vs 17.4%; OR 3.84; p=0.0066). Additional significant findings included increased percent days abstinent (placebo-adjusted +18.4%; p=0.0075), reduced serum PEth (difference -175.3; p<0.0001), and placebo-adjusted weight loss of 9.1% at 24 weeks (p<0.0001).

Safety was described as generally favorable; GI AEs were more common with pemvidutide, and study drug-related discontinuations occurred in 5/50 (10%). Altimmune plans to request an End-of-Phase 2 FDA meeting; results will be submitted to a medical conference and journal. The RESTORE ALD trial enrollment completion is expected in Q3 2026, and PERFORMA Phase 3 in MASH is planned to start in Q3 2026.