What are the key findings from Altimmune's IMPACT Phase IIb trial for pemvidutide?

The IMPACT trial showed pemvidutide significantly improved liver fibrosis markers (ELF and LSM) and reduced liver fat and inflammation in MASH patients over 48 weeks.

Has Altimmune discussed pemvidutide's Phase III trial plans with the FDA?

Yes, Altimmune has aligned with the FDA on the parameters required for a registrational Phase III trial of pemvidutide in MASH patients.

What is pemvidutide and how does it treat MASH?

Pemvidutide is a balanced 1:1 glucagon/GLP-1 dual receptor agonist being investigated for MASH, targeting both liver-specific and metabolic drivers of the disease.

Home / Health / MASH Drug Pemvidutide Shows Major Liver Health Gains

MASH Drug Pemvidutide Shows Major Liver Health Gains

22 Dec

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Summary

Pemvidutide demonstrated significant improvements in key liver fibrosis markers.
Statistically significant reductions in liver fat and inflammation were observed.
Phase III trial alignment with FDA signals path to market.

MASH Drug Pemvidutide Shows Major Liver Health Gains

Altimmune has announced positive topline results from its IMPACT Phase IIb trial for pemvidutide, a dual glucagon/GLP-1 receptor agonist, targeting patients with metabolic dysfunction-associated steatohepatitis (MASH). The trial met its primary endpoints, showing statistically significant improvements in key non-invasive tests (NITs) for liver stiffness and fibrosis over a 48-week period.

The study revealed that pemvidutide, at both 1.2mg and 1.8mg doses, led to substantial reductions in liver fibrosis markers such as Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM). Significant decreases were also noted in liver fat content and alanine aminotransferase (ALT) levels, alongside notable weight loss.

Following these encouraging outcomes, Altimmune has aligned with the Food and Drug Administration (FDA) on the parameters for a registrational Phase III trial. The company intends to initiate this Phase III program in 2026, aiming to further evaluate pemvidutide's potential as a differentiated therapeutic candidate for MASH patients.