Altimmune Starts Global Phase 3 PERFORMA Trial To Evaluate Pemvidutide For MASH After Promising Mid-Stage Results

Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company focused on developing treatments for serious liver diseases, has begun enrolling patients in its global Phase 3 PERFORMA clinical trial. The study will evaluate the safety and efficacy of pemvidutide, an investigational dual glucagon/GLP-1 receptor agonist, in people with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis. Pemvidutide is also being developed as a potential treatment for alcohol use disorder (AUD) and alcohol-associated liver disease (ALD).

PERFORMA is a randomized, double-blind, placebo-controlled Phase 3 study designed as Altimmune's registrational trial for pemvidutide in MASH. The trial will assess the drug's ability to improve liver fibrosis, resolve MASH, and deliver meaningful long-term clinical benefits. Its design is based on encouraging data from the Phase 2b IMPACT study and incorporates recommendations from the U.S. Food and Drug Administration (FDA) and European regulatory authorities. Altimmune expects to report the trial's 52-week data in 2029.

According to Chief Medical Officer Christophe Arbet-Engels, M.D., Ph.D., the favorable safety, tolerability, and efficacy results from the IMPACT Phase 2 trial provided strong confidence to advance pemvidutide into late-stage development. He said the therapy's balanced glucagon and GLP-1 receptor activity is designed to improve metabolic health while also acting directly on the liver, giving it the potential to become an important treatment option for patients with MASH and other serious liver diseases.

Chief Executive Officer and Chairman Jerry Durso said the launch of the PERFORMA trial marks an important milestone for the company's liver disease program. He noted that Altimmune moved from securing funding for the study to enrolling patients in just three months, reflecting the company's focus on executing its clinical development plans efficiently. He also highlighted the continued progress of the pemvidutide program, including recently reported positive Phase 2 RECLAIM trial results in alcohol use disorder.

In the earlier IMPACT Phase 2b study, pemvidutide demonstrated statistically significant MASH resolution, improvements in non-invasive measures of liver fibrosis and overall liver health, meaningful weight loss, and a generally favorable safety profile. Based on these findings, the FDA granted the therapy both Fast Track Designation and Breakthrough Therapy Designation for the treatment of MASH, recognizing its potential to address a major unmet medical need.

MASH affects millions of people worldwide and is a leading cause of liver fibrosis, cirrhosis, liver transplantation, and liver-related deaths. More than 80% of patients with the disease are overweight or obese, highlighting the need for treatments that address both liver damage and underlying metabolic dysfunction. Principal investigator Dr. Naim Alkhouri said the PERFORMA trial will help determine whether the broad clinical benefits seen with pemvidutide in earlier studies can be confirmed in a larger patient population and translate into meaningful long-term outcomes.