Core Insights - Altimmune, Inc. announced significant 24-week efficacy and safety data from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), showing promising results in MASH resolution, weight loss, and anti-fibrotic activity [1][3][5] Group 1: Trial Results - The IMPACT Phase 2b trial demonstrated that pemvidutide achieved statistically significant MASH resolution without worsening fibrosis, with 58% and 52% of patients in the 1.2 mg and 1.8 mg groups respectively achieving this outcome compared to 20% in the placebo group [6] - Significant improvements were observed in secondary endpoints, including a reduction in liver stiffness measurement and Enhanced Liver Fibrosis score, with the 1.2 mg and 1.8 mg groups showing reductions of -3.7 kPa and -2.2 kPa respectively [6] - The trial also reported a normalization of liver fat content in 31% and 44% of patients in the 1.2 mg and 1.8 mg groups respectively, compared to only 4% in the placebo group [6] Group 2: Safety and Tolerability - Pemvidutide exhibited a favorable tolerability profile, with only 2% of placebo patients experiencing adverse events leading to treatment discontinuation, compared to 0% in the 1.2 mg group and 1% in the 1.8 mg group [6] - Serious adverse events were reported in 3% of placebo patients, 2% in the 1.2 mg group, and 4% in the 1.8 mg group, with no serious adverse events deemed related to the treatment [6] Group 3: Future Outlook - The final readout of longer-term non-invasive tests and weight loss from the IMPACT trial is anticipated in the fourth quarter of 2025, which will provide further insights into the efficacy of pemvidutide [7][10] - The FDA has granted Fast Track designations to pemvidutide for the treatment of MASH and alcohol use disorder (AUD), indicating significant unmet medical needs in these areas [10]
Altimmune Announces Publication of IMPACT Phase 2b Trial Data in The Lancet and Concurrent Late-Breaking Oral Presentation at AASLD The Liver Meeting® 2025