Altimmune, Inc. (ALT) Thursday announced positive topline results from the IMPACT Phase 2b study of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH). The study met its primary goal.
In the Phase 2b study, participants were randomized to receive either pemvidutide at 1.2 mg or 1.8 mg doses or placebo for 24 weeks. In an intent-to-treat (ITT) analysis, in which participants with missing biopsies were considered non-responders, MASH resolution without worsening of fibrosis was achieved in 59.1% and 52.1% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, compared with 19.1% of participants treated with placebo. The effects on fibrosis improvement without worsening of MASH in an ITT analysis were 31.8% and 34.5% for pemvidutide 1.2 mg and 1.8 mg, respectively compared with 25.9% for placebo.
An AI-based analysis showed statistically significant reductions in fibrosis, including 30.6% of participants receiving pemvidutide 1.8 mg achieving a 60% or more reduction in fibrosis compared to 8.2% receiving placebo.
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