Altimmune registers Phase 3 pemvidutide trial in MASH under "PERFORMA" name

Altimmune's week centered on the registration of a new Phase 3 trial for pemvidutide in liver disease.

• Pemvidutide, tested via subcutaneous injection at 1.8 mg or 2.4 mg doses against placebo, is the subject of a new Phase 3 trial called "A Phase 3, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in Subjects With Noncirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)"¹, registered under the acronym PERFORMA. The study is recruiting, with an estimated enrollment of 1800 participants¹ across two cohorts, one selected by liver biopsy criteria and one by non-invasive test criteria¹. Primary outcomes include time to a first clinical outcome event, defined as histologic progression to cirrhosis, liver related events, liver transplantation, or death from any cause, measured from baseline through the end of study at approximately Month 60¹, along with MASH resolution without worsening of fibrosis and at least one stage of fibrosis improvement without worsening of MASH, both assessed at Week 52¹. The trial's start date is listed as July 30, 2026, with primary completion estimated for December 2028 and study completion estimated for December 2032¹. Sites are currently limited to nine locations in the United States¹, sponsored by Altimmune, Inc.¹