Altimmune(US:ALT) Globenewswire·2025-12-19 11:30Core Insights - Altimmune, Inc. announced positive topline results from the IMPACT Phase 2b trial of pemvidutide, a dual receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) at 48 weeks [2][3] Group 1: Trial Results - Statistically significant improvements in key non-invasive markers of fibrosis, including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), were observed across treatment arms compared to placebo [3][5] - The 1.2 mg and 1.8 mg doses of pemvidutide achieved mean reductions in ELF of -0.49 and -0.58 respectively, versus +0.16 in placebo (p<0.0001) [5] - The 1.2 mg and 1.8 mg doses achieved mean reductions in LSM of -3.04 (p<0.05) and -3.97 (p<0.001) respectively, compared to -0.03 in placebo [5] - Participants receiving pemvidutide also showed significant reductions in liver fat content, alanine aminotransferase (ALT), and corrected T1 (cT1) [5] - Weight loss was observed with the 1.2 mg and 1.8 mg doses at 4.5% and 7.5% respectively, compared to 0.2% in placebo (p<0.0001) [13] Group 2: Tolerability and Safety - The tolerability profile of pemvidutide was favorable at 48 weeks, with low treatment-related discontinuation rates of 0% and 1.2% for the 1.2 mg and 1.8 mg doses respectively, compared to 3.5% for placebo [13] - No serious or severe adverse events related to treatment were reported [13] Group 3: Regulatory Progress - The company held a productive End-of-Phase 2 meeting with the FDA, aligning on parameters for a registrational Phase 3 trial for pemvidutide in MASH patients with moderate to advanced liver fibrosis [6][7] - The FDA's qualification of AIM-MASH AI Assist was noted, which aims to standardize histologic assessment in the Phase 3 trial [6] Group 4: Future Plans - The company plans to initiate the Phase 3 program for pemvidutide in 2026, leveraging the strong evidence of antifibrotic improvements and favorable tolerability [7]