Altimmune Introduces Breakthrough Pemvidutide for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis
Altimmune has introduced pemvidutide for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and other metabolic liver diseases.
Pemvidutide is an investigational peptide with balanced 1:1 glucagon and GLP-1 dual receptor agonist activity. It is being developed for the treatment of MASH and other metabolic and liver-related conditions.
Pemvidutide had previously received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of MASH and alcohol use disorder. Breakthrough Therapy Designation has now been granted following the submission of clinical data from the Phase 2b IMPACT study.
Following recent regulatory interactions, alignment has been reached with the FDA on the design elements of a registrational Phase 3 trial in patients with moderate to advanced liver fibrosis. A Phase 3 study is planned to evaluate multiple dose levels over a 52-week treatment period. Further regulatory engagement, including consultation with European authorities, is expected prior to finalisation of the Phase 3 development programme.
MASH is characterised by fat accumulation, inflammation and fibrosis in the liver. If left untreated, the condition may progress to cirrhosis, liver failure or liver cancer. Current treatment options remain limited.
Pemvidutide has also received Fast Track Designation from the FDA for MASH and alcohol use disorder. Clinical development programmes in alcohol use disorder and alcohol-associated liver disease are ongoing.
Pemvidutide is among the investigational therapies to receive U.S. FDA Breakthrough Therapy Designation for the treatment of MASH, providing a potential new therapeutic approach for individuals living with this progressive liver disease.
