Pemvidutide - (PERFORMA)

August 3, 2026: Altimmune, Inc. (NASDAQ: ALT) announced first patient enrollment in PERFORMA, a global registrational Phase 3 trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH) in adults with confirmed F2-F3 fibrosis, advancing the program into late-stage development after positive IMPACT Phase 2b data.

PERFORMA is a randomized, double-blind, placebo-controlled, event-driven study assessing fibrosis improvement, MASH resolution, safety, and clinical outcomes. Cohort 1 will enroll about 990 patients for an interim analysis aimed at accelerated approval, using a biopsy-based primary endpoint of MASH resolution and/or fibrosis improvement at 52 weeks. Cohort 2 will enroll about 800 patients identified by non-invasive tests to expand the safety dataset. Final approval is planned to be supported by liver-related events at about 60 months. A 52-week data readout is anticipated in 2029.

The company said IMPACT Phase 2b showed statistically significant MASH resolution, improvements in non-invasive fibrosis and liver health measures, meaningful weight loss, and generally favorable tolerability. Pemvidutide has FDA Fast Track and Breakthrough Therapy designations for MASH, and Fast Track for AUD. Other pemvidutide milestones noted: positive topline RECLAIM Phase 2 AUD results announced in July 2026, and RESTORE in alcohol-associated liver disease, initiated in July 2025, with enrollment completion expected in Q3 2026.