Altimmune disclosed that its 48‑week IMPACT Phase IIb study of pemvidutide in patients with metabolic dysfunction‑associated steatohepatitis (MASH) produced statistically significant improvements in key non‑invasive fibrosis markers, including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), compared with placebo.
The trial demonstrated that the 1.2 mg and 1.8 mg doses of pemvidutide reduced ELF scores by an average of 0.49 and 0.58 points, respectively, versus a 0.16‑point increase in the placebo group (p < 0.0001 for both doses). LSM reductions averaged 3.04 kPa for the 1.2 mg arm and 3.97 kPa for the 1.8 mg arm, compared with a negligible 0.03 kPa change in placebo (p < 0.05 and p < 0.001, respectively). Weight loss was sustained through week 48, with the 1.2 mg and 1.8 mg arms achieving 4.5 % and 7.5 % reductions, respectively, versus 0.2 % in placebo (p < 0.0001 for both doses). Treatment‑related discontinuation rates were 0 % for the 1.2 mg dose, 1.2 % for the 1.8 mg dose, and 3.5 % for placebo.
Chief Executive Officer Vipin Garg said the data “reinforce that pemvidutide may address both liver‑specific and metabolic drivers of MASH without compromising tolerability – three critical elements of a potential effective treatment for this patient population.” Principal investigator Mazen Noureddin added that the dose‑response observed, especially in the 1.8 mg arm, “strengthens confidence that pemvidutide’s dual‑agonist mechanism can translate into meaningful antifibrotic activity.” The company plans to initiate a registrational Phase 3 program in 2026, leveraging the FDA’s recent guidance on non‑invasive endpoints to streamline development.
Investors reacted positively to the data, with pre‑market trading reflecting confidence in the drug’s clinical trajectory. The results align with the FDA’s emphasis on non‑invasive fibrosis markers, a factor that has historically accelerated regulatory review for MASH therapies. Analysts noted that the sustained weight loss and low discontinuation rates support the drug’s safety profile, a key consideration for long‑term treatment.
Financially, Altimmune reported a cash balance of $210.8 million as of September 30, 2025, and has secured a credit facility of up to $100 million to support ongoing development. While the company has a history of operating losses, the positive trial data are expected to enhance its valuation and attract additional funding for Phase 3 and parallel studies in alcohol‑associated liver disease.
Altimmune’s 48‑week IMPACT results represent a pivotal step toward a potential first‑in‑class therapy for MASH and a broader portfolio expansion into alcohol‑related liver disease. The data provide a strong foundation for the upcoming Phase 3 program and reinforce the company’s strategy of leveraging pemvidutide’s dual GLP‑1/glucagon receptor agonism to address both metabolic and fibrotic components of liver disease.
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