Therapy Areas: Inflammatory Diseases
Altimmune's pemvidutide granted FDA Fast Track designation for NASH treatment
26 October 2023 -

Clinical-stage biopharmaceutical company Altimmune Inc (Nasdaq:ALT) said on Thursday that the US Food and Drug Administration (FDA) has granted Fast Track designation to its clinical programme for pemvidutide as a potential treatment for Non-Alcoholic Steatohepatitis (NASH).

NASH is a serious and life-threatening condition, a leading cause of global liver failure and transplantation, with no approved treatments available.

Fast Track designation is aimed at expediting the development and review of drugs addressing critical medical needs. Altimmune's Phase 1b study demonstrated significant reductions in liver fat and hepatic inflammation markers for pemvidutide.

The efficacy and safety of pemvidutide in NASH are under evaluation in the IMPACT Phase 2b trial at approximately 60 US sites, with around 190 enrolled subjects. The trial is assessing NASH resolution and fibrosis improvement after 24 weeks of treatment, with safety and biomarker responses observed for an additional 24 weeks. Concurrently, the MOMENTUM Phase 2b trial is examining pemvidutide's impact on obesity at about 30 US sites, with full data for 391 subjects expected this quarter.