Altimmune Secures FDA Breakthrough Therapy Designation for Pemvidutide in MASH
Altimmune, Inc., has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
The designation is based on 24-week Phase 2b IMPACT trial data demonstrating significant MASH resolution without worsening fibrosis, alongside early improvements in liver fat and non-invasive markers of fibrosis and inflammation.
Additional 48-week data confirmed ongoing antifibrotic activity, further weight reduction, and a favourable tolerability profile.
Pemvidutide is being developed to address the metabolic and fibrotic components of MASH, a progressive liver disease that can lead to cirrhosis, liver failure, or liver cancer.
Current treatment options do not fully target both underlying metabolic dysfunction and fibrosis.
Following a productive end-of-phase 2 meeting with the FDA, Altimmune has finalised parameters for a registrational Phase 3 trial in patients with moderate to advanced liver fibrosis, incorporating biopsy-based endpoints and the FDA-qualified AIM-MASH AI pathology tool.
Pemvidutide is also under investigation for alcohol use disorder (AUD) and alcohol-associated liver disease (ALD), with ongoing Phase 2 trials in these indications.
