Altimmune, Inc. (NASDAQ: ALT) has recently reported positive topline results from the IMPACT phase 2b trial of pemvidutide in the treatment of metabolic dysfunction-associated steatohepatitis (MASH). In this 24-week trial, participants receiving pemvidutide demonstrated significant improvement in MASH effects and weight loss compared to those receiving a placebo.
The trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes, randomized to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses or placebo. The primary endpoint was met, with statistically significant MASH resolution without worsening of fibrosis in up to 59.1% of participants in an intent-to-treat (ITT) analysis. Additionally, fibrosis improvement without worsening of MASH was observed in up to 34.5% of participants in an ITT analysis.
Supplemental AI-based analysis demonstrated statistically significant reductions in liver fibrosis at 24 weeks, with weight loss of up to 6.2% and potentially best-in-class tolerability, as less than 1% of participants treated with pemvidutide discontinued treatment due to adverse events.
Dr. Mazen Noureddin, co-chairman of the board for Summit and Pinnacle Clinical Research, highlighted the unique combination of MASH resolution and weight loss achieved within 24 weeks, along with the impressive tolerability of pemvidutide. Dr. Scott Harris, Chief Medical Officer of Altimmune, emphasized the significant MASH resolution and evidence of fibrosis improvement at 24 weeks, paving the way for a successful end of phase 2 meeting with the FDA in the fourth quarter of 2025 and enabling rapid progression to phase 3.
Key highlights from the 24-week topline results include: MASH resolution without worsening of fibrosis in 59.1% and 52.1% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 19.1% of participants treated with placebo. Weight loss of 5.0% and 6.2% in participants receiving pemvidutide 1.2 mg and 1.8 mg, respectively, versus 1.0% in the placebo group. Liver fat reductions of 58.0% and 62.8% were achieved in participants who received pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 16.2% in participants who received placebo. Adverse events leading to treatment discontinuation were 0.0% and 1.2% for pemvidutide 1.2 mg and 1.8 mg, respectively, versus 2.4% in participants on placebo.
Altimmune will host a conference call and webcast to review the topline IMPACT data, including a discussion of the data and its implications with IMPACT principal investigator, Dr. Mazen Noureddin, M.D., MHSC.
Pemvidutide is a novel, investigational, peptide-based 1:1 GLP-1/glucagon dual receptor agonist in development for the treatment of MASH, obesity, alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). The U.S. FDA has granted fast track designation to pemvidutide for the treatment of MASH. Today the company's shares have moved 7.23% to a price of $7.71. If you want to know more, read the company's complete 8-K report here.
