Altimmune Receives FDA Breakthrough Therapy Designation for Pemvidutide in MASH

Core Insights - The U.S. FDA has granted Breakthrough Therapy Designation for pemvidutide, a dual receptor agonist, for treating metabolic dysfunction-associated steatohepatitis (MASH) [1][3][7] - The designation is based on promising Phase 2b trial data showing significant MASH resolution and improvements in liver health markers [3][4] Company Overview - Altimmune, Inc. is a late clinical-stage biopharmaceutical company focused on therapies for serious liver diseases, with pemvidutide as its lead candidate [9] - The company aims to advance pemvidutide through late-stage development, emphasizing its commitment to patient care and stakeholder value [3][4] Clinical Development - The FDA's Breakthrough Therapy Designation was supported by 24-week data from the IMPACT Phase 2b trial, which demonstrated significant improvements in liver fat and fibrosis without worsening conditions [3][4] - Altimmune plans to initiate a Phase 3 trial for pemvidutide, evaluating multiple doses over a 52-week period, incorporating biopsy-based endpoints for potential accelerated approval [4] Disease Context - MASH is a progressive liver disease characterized by fat accumulation, inflammation, and fibrosis, which can lead to severe complications like cirrhosis and liver cancer [5] - Current treatment options for MASH may not adequately address both metabolic drivers and fibrosis, highlighting the need for effective therapies like pemvidutide [5] Mechanism of Action - Pemvidutide is a novel investigational peptide that acts as a balanced 1:1 glucagon/GLP-1 dual receptor agonist, targeting liver fat reduction, inflammation, and fibrosis while also promoting appetite suppression and weight loss [6]