GAITHERSBURG, Md., Aug. 3, 2026
Altimmune, Inc. has initiated patient enrollment in the global PERFORMA Phase 3 registrational trial evaluating pemvidutide for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). The late-stage study follows encouraging results from the IMPACT Phase 2b trial and incorporates regulatory feedback from the U.S. Food and Drug Administration (FDA) and European health authorities. Designed to support both accelerated and full regulatory approval, PERFORMA will evaluate pemvidutide’s ability to improve liver fibrosis, achieve MASH resolution, and reduce long-term liver-related clinical outcomes. The investigational therapy has previously received both FDA Fast Track and Breakthrough Therapy Designations for MASH.
PERFORMA Phase 3 Advances Registrational Development in MASH
PERFORMA is a global, randomized, double-blind, placebo-controlled Phase 3 study enrolling approximately 1,790 patients with biopsy-confirmed MASH and moderate-to-advanced liver fibrosis (F2–F3). The study consists of two parallel cohorts, with the first enrolling around 990 patients to support the accelerated approval pathway through biopsy-based assessment of fibrosis improvement and MASH resolution after 52 weeks of treatment. A second cohort of approximately 800 patients will strengthen the overall safety database using patients identified through non-invasive fibrosis assessments. The trial will also incorporate the FDA-qualified AIM-MASH AI Assist tool to standardize liver biopsy interpretation, while long-term clinical outcome data collected over approximately 60 months are expected to support full regulatory approval. Altimmune anticipates the primary 52-week efficacy readout in 2029.
Positive Phase 2b Results Support Late-Stage Development
The PERFORMA trial builds upon positive findings from the IMPACT Phase 2b study, where pemvidutide demonstrated statistically significant rates of MASH resolution, improvements in non-invasive markers of liver fibrosis and liver health, clinically meaningful weight reduction, and a favorable safety and tolerability profile. Pemvidutide is a balanced 1:1 glucagon/GLP-1 dual receptor agonist designed to directly target liver inflammation and fibrosis while simultaneously improving metabolic dysfunction through appetite suppression and weight loss. Beyond MASH, the therapy is also under clinical development for alcohol use disorder (AUD) and alcohol-associated liver disease (ALD), reflecting Altimmune’s broader strategy of addressing chronic liver diseases through a single therapeutic platform.
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Altimmune Expands Late-Stage Liver Disease Pipeline
The initiation of PERFORMA marks a significant milestone in Altimmune’s transition into late-stage clinical development and strengthens its growing liver disease franchise. Company leadership highlighted the rapid progression from securing financing for the Phase 3 program to initiating patient enrollment within three months, demonstrating continued execution across the pemvidutide development program. With ongoing clinical studies in MASH, alcohol use disorder, and alcohol-associated liver disease, Altimmune continues advancing pemvidutide as a differentiated dual-action therapy designed to address both liver pathology and the underlying metabolic drivers of disease. Successful completion of PERFORMA could position pemvidutide as an important new treatment option for patients living with MASH, a disease affecting millions worldwide and a leading cause of liver fibrosis, cirrhosis, transplantation, and liver-related mortality.
Source: Altimmune,press release
