Pemvidutide Shows Promising Results in MASH Treatment
Here’s a summary of the key findings regarding pemvidutide for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH):
Efficacy:
* Liver Fat Reduction: Pemvidutide significantly reduced liver fat content. 1.2mg dose reduced it by 45.2%, and 1.8mg by 54.7%, compared to only 8.2% with placebo (highly statistically significant – P* < .0001).
* ALT Levels: Pemvidutide lowered ALT levels (a marker of liver damage) by -37.8 IU/L (1.2mg) and -37.4 IU/L (1.8mg) versus -10.3 IU/L with placebo (P* < .0001 for both).
* cT1 (Liver Stiffness): Pemvidutide reduced cT1 (a measure of liver stiffness, indicating fibrosis) by -124 ms (1.2mg) and -140 ms (1.8mg) compared to -21 ms with placebo (P* < .0001).
* Weight Loss: Patients on pemvidutide lost 4.5% (1.2mg) and 7.5% (1.8mg) of their weight, compared to 0.2% with placebo (P* < .0001). The 1.8mg dose showed no plateau in weight loss over 48 weeks.
Safety:
* discontinuation Rates: Low rates of treatment discontinuation due to adverse events: 0% (1.2mg), 1.2% (1.8mg) vs. 3.5% (placebo).
* Adverse Events: No serious or severe treatment-related adverse events were reported.
Future Plans:
* phase 3 Trial: Altimmune is working with the FDA on a Phase 3 trial for MASH patients with moderate to advanced liver fibrosis.
* Trial Design: The trial will evaluate multiple doses of pemvidutide over 52 weeks and will use liver biopsies as endpoints.
* AI Integration: The trial will incorporate AIM-MASH AI Assist, an FDA-qualified AI pathology tool, to aid in the analysis of biopsies.
Reference: Altimmune Receives FDA Breakthrough Therapy Designation for Pemvidutide in MASH. News release. Altimmune. January 5, 2026. https://www.globenewswire.com/news-release/2026/01/05/3212638/0/en/Altimmune-Receives-FDA-breakthrough-Therapy-Designation-for-Pemvidutide-in-MASH.html
