Clinical TrialAug 3, 2026, 08:03 AM
Altimmune Initiates Phase 3 PERFORMA Trial for MASH Treatment
AI Summary
Altimmune, Inc. announced the initiation of patient enrollment in its global PERFORMA Phase 3 trial for pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This advancement into late-stage development follows positive results from the IMPACT Phase 2b study and incorporates feedback from the U.S. FDA and European regulatory agencies. The trial aims to evaluate pemvidutide's efficacy and safety, with a 52-week data readout expected in 2029, and is designed to support both accelerated and final regulatory approval.
Key Highlights
- Altimmune initiated the global PERFORMA Phase 3 trial for pemvidutide in MASH patients.
- The trial is a randomized, double-blind, placebo-controlled study evaluating efficacy and safety.
- Initiation follows positive IMPACT Phase 2b data and regulatory feedback from FDA and Europe.
- 52-week data readout from the PERFORMA trial is anticipated in 2029.
- Pemvidutide holds FDA Fast Track and Breakthrough Therapy Designations for MASH.
- Cohort 1 will enroll approximately 990 patients for accelerated approval pathway.
- Cohort 2 will enroll approximately 800 patients to expand the safety dataset.
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