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Altimmune Begins Patient Enrollment for Pemvidutide Phase 3 Trial

Altimmune announced that the company has begun enrolling patients in the PERFORMA Phase 3 trial evaluating the efficacy and safety of pemvidutide in patients with metabolic dysfunction-associated steatohepatitis. Pemvidutide is an investigational balanced glucagon/GLP-1 dual receptor agonist also in development for the treatment of alcohol use disorder and alcohol-associated liver disease.

Altimmune Reports Significant Results from RECLAIM Phase 2 Trial

Altimmune announced topline results from the RECLAIM Phase 2 trial evaluating pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, in patients with moderate to severe alcohol use disorder. The trial met its primary endpoint with a highly statistically significant reduction in heavy drinking days versus placebo, with consistent positive results across important secondary endpoints, including the World Health Organization Risk Drinking Levels, zero HDD and phosphatidyl ethanol levels. A generally favorable tolerability profile was observed in the trial. The company plans to request an End-of-Phase 2 meeting with the FDA based on the results of the trial. Statistically significant reduction in the primary endpoint of HDD per week versus placebo. Statistically significant results on secondary endpoints, including two that are registrational endpoints. Two-level reduction in WHO Risk Drinking Levels versus placebo. Zero heavy drinking days versus placebo. Statistically significant change in percent of days with abstinence versus placebo. Statistically significant reduction in PEth levels versus placebo. Statistically significant reduction in body weight, as measured by a placebo-adjusted difference in change from baseline of 9.1% at 24 weeks, with no evidence of plateauing. Pemvidutide was generally well tolerated in this patient population with high unmet need. The new, simple two-step titration for the 2.4 mg dose may improve gastrointestinal tolerability compared to prior pemvidutide titration schemes. The majority of adverse events were mild to moderate in severity. There was one serious adverse event in the pemvidutide arm that was deemed possibly related to treatment drug by the principal investigator. Based on these data, Altimmune plans to request an End-of-Phase 2 meeting with the FDA to discuss the path forward for pemvidutide in AUD. Results from the RECLAIM trial will be submitted for presentation at a forthcoming medical conference and for publication in a peer-reviewed journal.

Altimmune Reports Pemvidutide 48-Week Trial Data Significantly Improves Metabolic Risks

Altimmune announced that new 48-week data from the IMPACT Phase 2b trial show that pemvidutide, an investigational balanced glucagon/GLP-1 dual receptor agonist, significantly reduced elevated lipids while improving multiple cardiometabolic risk factors in patients with metabolic dysfunction-associated steatohepatitis. The findings demonstrated reductions in triglycerides and total cholesterol, along with improvements in weight, waist circumference and blood pressure, highlighting the broad impact of pemvidutide on key drivers of MASH. The data were presented for the first time at the European Association for the Study of the Liver Congress 2026 in Barcelona, Spain. Highlights of the 48-week data presented at EASL 2026 include: Pemvidutide 1.8 mg treatment resulted in significant reductions in serum lipid levels among patients with elevated baseline values versus placebo, including: Triglycerides reductions of -23.7%; Total cholesterol reductions of -15.4%. In addition to lipids, pemvidutide 1.8 mg treatment resulted in significant improvements in other metabolic risk factors versus placebo: Weight loss of 7.5%, continuing throughout treatment with no plateauing; Reductions in body mass index of -3.0 kg/m2; Reductions in waist circumference of -5.3 cm; Improvements in systolic blood pressure of -4.0 mmHg and diastolic blood pressure of -2.2 mmHg. Results also showed that the safety profile of pemvidutide was maintained at 48 weeks, and the tolerability profile was generally favorable without dose titration. Approximately 1% of total patients receiving pemvidutide discontinued treatment due to adverse events. The majority of AEs were mild to moderate, and no imbalances in cardiac AEs were observed with pemvidutide versus placebo. Most gastrointestinal AEs were mild to moderate in severity and predominantly occurred within the first 8 weeks. Previously reported IMPACT Phase 2b trial results showed the proportion of patients achieving both a greater than or equal to0.5 reduction in Enhanced Liver Fibrosis and a greater than or equal to30% reduction in Liver Stiffness Measurement at week 48 was 3.2% with placebo, compared with 27.8% for pemvidutide 1.2 mg and 32.4% for pemvidutide 1.8 mg.