Major Reductions in Liver Fibrosis and Inflammation Set Pemvidutide Apart at 48 Weeks
Altimmune’s lead candidate, pemvidutide, is making waves with positive 48-week data from the IMPACT Phase 2b MASH trial. The therapy produced significant reductions in key non-invasive measures of liver fibrosis and inflammation, including Enhanced Liver Fibrosis (ELF), Liver Stiffness Measurement (LSM), liver fat content, and corrected T1 (cT1), compared to placebo. These findings reinforce pemvidutide’s potential to address both liver-specific and metabolic aspects of MASH (metabolic dysfunction-associated steatohepatitis)—a progressive and difficult-to-treat liver disease.
Efficacy Data: Pemvidutide Shows Marked Advantages Over Placebo
| Measure | Pemvidutide 1.2 mg | Pemvidutide 1.8 mg | Placebo | p-value (Both Doses) |
|---|---|---|---|---|
| ELF Score (mean reduction from baseline) | -0.49 | -0.58 | +0.16 | <0.0001 |
| LSM (kPa, mean reduction) | -3.04 | -3.97 | -0.03 | <0.05 (1.2), <0.001 (1.8) |
| Liver Fat Content (% reduction) | 45.20% | 54.70% | 8.20% | <0.0001 |
| ALT (IU/L, mean reduction) | -37.80 | -37.40 | -10.30 | <0.0001 |
| cT1 (ms, mean reduction) | -124 | -140 | -21 | <0.0001 |
| Weight Loss (% from baseline) | 4.50% | 7.50% | 0.20% | <0.0001 |
| Both =0.5 ELF and 30% LSM Reduction | 27.80% | 32.40% | 3.20% | <0.001 (1.2), <0.0001 (1.8) |
What stands out most is the durable improvement from week 24 to week 48, particularly in liver stiffness and fat reduction. Notably, the higher 1.8 mg dose led to continued weight loss without plateauing, addressing a critical challenge in the long-term management of MASH.
Safety and Tolerability: Strong Profile Supports Next Phase
Pemvidutide’s tolerability profile remains a major strength. Discontinuation due to adverse events was lower in both treatment groups (0% for 1.2 mg; 1.2% for 1.8 mg) compared to 3.5% in placebo, and no serious or severe treatment-related adverse events were reported. This risk-benefit balance is key, as liver treatments are often limited by side effects.
FDA Alignment Enables Accelerated Path to Phase 3 Trial
The 48-week results provided the basis for a productive end-of-Phase 2 meeting with the FDA, paving the way for a registrational Phase 3 trial. Importantly, the upcoming trial aims to integrate AIM-MASH AI Assist—a newly qualified tool designed to streamline histological assessments—reflecting an evolving landscape for clinical trial efficiency in liver disease. Altimmune plans to initiate the pivotal study in 2026, building on both the clinical efficacy and the patient-friendly safety profile shown so far.
Key Takeaways for Investors and Stakeholders
The breadth and depth of pemvidutide’s impact in the IMPACT Phase 2b study position Altimmune as a frontrunner in the MASH space, particularly for patients with moderate to advanced fibrosis. Statistically significant and clinically meaningful improvements in multiple validated non-invasive measures of liver health—paired with an attractive side effect profile—distinguish this program. As Phase 3 gets underway, the biopharma community will be watching closely to see if these benefits are sustained in a larger, longer-term setting.
To learn more, Altimmune is hosting a webcast today at 8:00 am ET. Details are available on the company’s investor relations website.
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