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Altimmune Presents AI-Based Analysis of Liver Fibrosis Reduction from IMPACT Phase 2b Trial of Pemvidutide in MASH in Late-breaking Poster at AASLD The Liver Meeting® 2025

Core Insights - Altimmune, Inc. announced significant results from the IMPACT Phase 2b trial of pemvidutide, demonstrating reductions in liver fibrosis and improvements in non-invasive tests compared to placebo at 24 weeks [1][2][5] Group 1: Trial Results - The AI-based pathology tool Liver Explore™ showed significant reductions in early, advanced, and total liver fibrosis areas with pemvidutide treatment compared to placebo at 24 weeks [2] - In the trial, 58% of patients achieved MASH resolution, indicating the efficacy of the glucagon/GLP-1 balanced approach in pemvidutide [5] - Statistically significant reductions in total liver fibrosis were observed, with 31% of patients in the 1.8 mg group achieving a ≥ 60% reduction compared to 8% in the placebo group [7] Group 2: Study Design - The IMPACT Phase 2b trial was a randomized, placebo-controlled, double-blind study involving 212 participants with biopsy-confirmed MASH and fibrosis stages F2 or F3 [6] - Participants were randomized to receive weekly subcutaneous doses of pemvidutide at either 1.2 mg, 1.8 mg, or placebo for 48 weeks, with key efficacy endpoints measured at 24 weeks [6] Group 3: Mechanism and Future Outlook - Pemvidutide is a novel investigational peptide with dual receptor agonist activity targeting both glucagon and GLP-1, aimed at treating MASH, AUD, and ALD [8] - The FDA has granted Fast Track designations for pemvidutide in treating MASH and AUD, highlighting the unmet medical need in these areas [9] - The final readout of the ongoing 48-week IMPACT trial is anticipated in the fourth quarter of 2025, which will include longer-term data on non-invasive tests and weight loss [9]