Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapies for liver and cardiometabolic diseases, has announced the results of an AI-based analysis of liver biopsies from the Phase 2b IMPACT trial of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH). The analysis, conducted using the company’s proprietary AI-powered digital pathology platform, Liver Explore™, revealed significant reductions in liver fibrosis after 24 weeks of treatment with pemvidutide compared to placebo. The AI tool provided high-resolution, quantitative assessment of fibrosis, measuring reductions in early, advanced, and total fibrotic areas. These findings were further supported by improvements in non-invasive tests (NITs) of liver fibrosis, including the PRO-C3:CTX-III ratio, which reflects fibrosis regression, and PRO-C6, a marker associated with cardiovascular risk. The data will be presented in a late-breaking poster session at The Liver Meeting 2025, hosted by the American Association for the Study of Liver Diseases (AASLD) in Washington, D.C., on November 8, 2025. Vlad Ratziu, MD, PhD, Professor of Hepatology at Sorbonne University and Pitié-Salpêtrière Hospital in Paris, highlighted the advantages of AI-based analysis, noting that traditional histological methods are often subjective and limited in precision. “AI-based methods offer automated, sensitive, and truly quantitative assessment of fibrosis changes, which is crucial for accurately evaluating new therapies in MASH,” he said. Christophe Arbet-Engels, M.D., Ph.D., Chief Medical Officer of Altimmune, emphasized the trial’s early success, stating that up to 58% of patients achieved MASH resolution in the 24-week study. “The balanced 1:1 glucagon/GLP-1 dual agonism in pemvidutide appears to drive rapid and meaningful improvements in both MASH and fibrosis,” he said. “The AI analysis confirms these benefits, showing statistically significant reductions in both early and advanced fibrosis with the 1.8 mg dose. We look forward to the 48-week data readout, which will include longer-term NITs and weight loss outcomes.” The IMPACT Phase 2b trial (NCT05989711) was a randomized, placebo-controlled, double-blind study involving 212 patients with biopsy-confirmed MASH and fibrosis stages F2 or F3, with or without diabetes. Participants were randomized 1:2:2 to receive weekly subcutaneous injections of pemvidutide at 1.2 mg, 1.8 mg, or placebo for 48 weeks. Key endpoints at 24 weeks included MASH resolution without worsening of fibrosis, and fibrosis improvement without worsening of MASH. Secondary endpoints included NITs and weight loss. The final 48-week data readout is expected in the fourth quarter of 2025. Pemvidutide is a first-in-class investigational dual glucagon/GLP-1 receptor agonist designed to target both liver-specific and metabolic pathways. Glucagon activation reduces liver fat, inflammation, and fibrosis, while GLP-1 activity supports weight loss and appetite control. The FDA has granted Fast Track designation to pemvidutide for both MASH and alcohol use disorder (AUD). Phase 2 trials for AUD (RECLAIM) and alcohol-associated liver disease (RESTORE) began in May and July 2025, respectively, and are currently ongoing. Altimmune remains focused on advancing its pipeline of peptide-based therapies for liver and metabolic conditions, with a strong commitment to innovation and data-driven development. The company’s forward-looking statements, including expectations for clinical trial results and regulatory progress, are subject to risks and uncertainties, including delays in trials, manufacturing challenges, and regulatory review timelines. For more information, visit www.altimmune.com.