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Altimmune Announces Publication of IMPACT Phase 2b 48-Week Data in MASH in The Lancet Gastroenterology & Hepatology

ALT
  • Altimmune announced the publication of 48-week results from the IMPACT Phase 2b trial of pemvidutide in The Lancet Gastroenterology & Hepatology.
  • The trial evaluated the balanced 1:1 glucagon/GLP-1 dual receptor agonist pemvidutide in 212 patients with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) & fibrosis stages F2 or F3.
  • Participants were randomized to receive weekly subcutaneous doses of 1.2 mg pemvidutide, 1.8 mg pemvidutide, or placebo for 48 weeks.
  • Treatment resulted in significant reductions versus placebo across non-invasive measures of liver fat, hepatic inflammation, & fibrosis.
  • Significant weight loss was observed with the 1.8 mg dose continuing through the end of the 48-week period.
  • Glycemic control was maintained, & no significant changes in heart rate were observed during treatment.
  • Pemvidutide demonstrated a generally favorable tolerability profile without dose titration, with approximately 1% of patients discontinuing due to adverse events.
  • Most adverse events were mild to moderate, predominantly occurring within the first 8 weeks, with no imbalances in cardiac adverse events.
  • These findings build upon previously published 24-week results where the primary endpoint of MASH resolution without worsening of fibrosis was met.
  • The results provide validation for pemvidutide's potential as a treatment for MASH & support the ongoing PERFORMA Phase 3 trial initiated in July 2026.
  • Pemvidutide holds Fast Track designations for MASH & alcohol use disorder (AUD), & a Breakthrough Therapy Designation for MASH.
Company
Altimmune, Inc
Keywords
Nasdaq:ALT, Altimmune, Inc