Altimmune (NASDAQ:ALT), a clinical-stage biopharmaceutical company focused on therapies for liver diseases, today announced encouraging topline results from its IMPACT Phase 2b trial of pemvidutide, a dual glucagon/GLP-1 receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH).
After 48 weeks, pemvidutide demonstrated significant improvements across key non-invasive markers of liver fibrosis and weight loss, providing further evidence of its potential as a treatment for this patient population.
The 48-week data from the IMPACT trial revealed that both treatment arms of pemvidutide (1.2 mg and 1.8 mg) achieved statistically significant reductions in Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), with continued improvements beyond the 24-week mark.
The trial showed that these reductions were sustained and reflected continued antifibrotic activity, key factors in assessing liver health and fibrosis.
These markers correlate strongly with histological changes and liver-related events, adding credibility to the treatment's effectiveness.
In addition, the 1.8 mg dose group showed continued weight loss, which was sustained with no signs of plateauing, in contrast to the 24-week results.
The treatment maintained a favorable tolerability profile, with a lower treatment-related discontinuation rate compared to placebo.
These results also reinforce the favorable safety and tolerability profile observed during the study, with no serious adverse events related to the treatment.
Altimmune also announced that following a productive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the company has aligned with the Agency on the parameters for moving forward to a registrational Phase 3 trial for pemvidutide in MASH patients with moderate to advanced liver fibrosis.
Additionally, the FDA’s recent qualification of AIM-MASH AI Assist—an AI tool to help standardize histologic assessments—has paved the way for its integration into the upcoming Phase 3 trial.