Altimmune disclosed that the 24‑week data from its IMPACT Phase 2b study of pemvidutide has been published in The Lancet and will be presented at the AASLD Liver Meeting in Washington, D.C. The peer‑reviewed report covers 212 patients who received weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg, or placebo, over a 48‑week period.
The study shows that pemvidutide achieved statistically significant resolution of metabolic‑associated steatohepatitis (MASH) without worsening fibrosis. Resolution rates were 58 % for the 1.2 mg dose and 52 % for the 1.8 mg dose, compared with 20 % in the placebo group. Liver fat content fell to 5 % or less in 31 % of patients on 1.2 mg and 44 % on 1.8 mg, versus 4 % on placebo.
Weight loss was also pronounced, with mean reductions of 4.8 % for 1.2 mg and 5.8 % for 1.8 mg, versus a 0.5 % loss in the placebo arm. Liver stiffness measurements dropped by 3.7 kPa (1.2 mg) and 2.2 kPa (1.8 mg), compared with a 0.7 kPa reduction in placebo. Enhanced Liver Fibrosis (ELF) scores decreased by 0.6 and 0.5 points in the treatment groups, while placebo increased by 0.03 points.
The safety profile was favorable, with no new safety signals and a tolerability rate comparable to placebo. Altimmune’s dual glucagon/GLP‑1 receptor agonist mechanism is highlighted as a differentiated approach that may address both hepatic and metabolic drivers of MASH.
These results reinforce Altimmune’s regulatory narrative. The company has Fast Track designation from the FDA for both MASH and alcohol‑associated liver disease, and an End‑of‑Phase 2 meeting is scheduled for Q4 2025 to align on Phase 3 design. The 48‑week readout, expected in the fourth quarter, will provide a more complete efficacy and safety picture.
Management emphasized the clinical significance of the rapid MASH resolution. Dr. Mazen Noureddin, principal investigator, noted that “the significant resolution of MASH after only 24 weeks, coupled with strong anti‑fibrotic activity and weight loss, suggests pemvidutide has the potential to meaningfully alter the course of this disease.” Chief Medical Officer Dr. Christophe Arbet‑Engels added that the data “reinforce our belief in pemvidutide’s differentiated mechanism and its potential to become an important treatment for patients with MASH.”
Altimmune’s Q3 2025 earnings report, released earlier in November, showed a net loss of $19.01 million ($0.21 per share) versus $22.85 million ($0.32 per share) in Q3 2024, with revenue essentially flat at $0.005 million. The clinical milestone is expected to strengthen investor confidence and support future commercialization plans for pemvidutide in liver and cardiometabolic indications.
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