Altimmune Inc. (ALT) announced that its investigational dual glucagon/GLP-1 receptor agonist, pemvidutide, achieved statistically significant improvements in non-invasive markers of liver fibrosis and sustained weight loss at 48 weeks in Phase 2b IMPACT trial in patients with metabolic dysfunction-associated steatohepatitis.
Metabolic dysfunction-associated steatohepatitis (MASH) is a progressive liver disease characterized by fat accumulation, inflammation, and fibrosis, and is one of the leading causes of liver transplantation in the United States. Current management relies largely on lifestyle interventions, with no approved therapies that fully address both metabolic drivers and fibrosis progression.
IMPACT is a randomized, placebo-controlled Phase 2b study that enrolled 212 adults with biopsy-confirmed MASH and fibrosis stage F2 or F3. Participants were assigned to weekly subcutaneous Pemvidutide doses of 1.2 mg, 1.8 mg or placebo for 48 weeks.
Key findings included:
•Fibrosis markers: Both doses achieved significant reductions in Enhanced Liver Fibrosis and Liver Stiffness Measurement compared to placebo, with continued improvement beyond the 24-week timepoint.
•Liver health: Pemvidutide reduced liver fat content by up to 54.7% and lowered alanine aminotransferase and corrected T1 scores, indicating improved hepatic inflammation
•Weight loss: Patients on the 1.8 mg dose achieved 7.5% mean weight loss at 48 weeks, with no evidence of plateauing.
•Safety: The drug maintained a favourable tolerability profile, with lower discontinuation rates than placebo and no serious treatment-related adverse events.
Altimmune has held an End-of Phase 2 meeting with the U.S. FDA, securing alignment to advance Pemividutide into a registrational Phase 3 trial in MASH patients with moderate to advanced fibrosis.
The company also plans to integrate AIM-MASH AI Assist, a newly qualified FDA tool, to standardize histologic assessment and streamline trial execution.
Beyond MASH, Pemvidutide is being investigated in alcohol use disorder and alcohol-associated liver disease, with Phase 2 trials initiated in 2025. Both the programs have received FDA Fast Track designation.
The company ended September 30, 2025, with cash, cash equivalents and short-term investments of $210.8 million.
ALT shares ranged between $2.90 and $8.75 over the past year. The stock is currently trading at $4.50, down 10.89%.
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