Altimmune's Pemvidutide Achieves Statistically Significant Liver Fibrosis Improvement in 48-Week MASH Trial, Supporting Phase III
Pemvidutide Data Shows Significant Gains in Liver Health and Weight Management
Altimmune, Inc. (ALT) announced robust topline results from the 48-week Phase IIb IMPACT trial of its investigational drug, **pemvidutide**, confirming its potential as a leading treatment for Metabolic Dysfunction-Associated Steatohepatitis (MASH). The data revealed that pemvidutide achieved statistically significant improvements across all treatment arms in key non-invasive tests (NITs) designed to measure liver health, notably the **Enhanced Liver Fibrosis (ELF)** and **Liver Stiffness Measurement (LSM)** scores, when compared to the placebo group.
The positive outcomes in these non-invasive markers are critical, as they signal substantial benefits for patients suffering from MASH, a progressive condition characterized by liver inflammation and damage due to fat accumulation. The successful 48-week data strongly supports the drug's progression to a Phase III study, aligning with regulatory expectations for accelerated approval pathways.
Key Financial and Clinical Metrics
The IMPACT trial results highlighted both the efficacy in treating liver pathology and the drug's systemic benefits, particularly weight management. The data demonstrated durable, dose-dependent improvements in fibrosis markers and consistent safety across the study period.
- Liver Health Improvement: Pemvidutide showed statistically significant improvements in NITs, including ELF and LSM, indicating a reduction in liver fibrosis and stiffness compared to placebo.
- Weight Loss Efficacy: Patients receiving the 1.8 mg dose of pemvidutide achieved a mean weight loss of **7.5%** over the 48-week duration. This dual benefit—treating MASH pathology while promoting weight loss—positions pemvidutide favorably in the competitive metabolic disorder landscape.
- Safety Profile: The trial confirmed a consistent safety profile, supporting the feasibility of long-term use necessary for chronic MASH treatment.
These findings were highlighted in the company's announcement, confirming that pemvidutide achieved key measures of success at the 48-week mark in the IMPACT trial.
The topline 48-week data from the IMPACT trial showed that treatment with pemvidutide achieved statistically significant improvements across treatment arms in key non-invasive tests (NITs), including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), versus placebo.
Path to Phase III and Regulatory Strategy
The strong Phase IIb results significantly de-risk the development path for Altimmune. Management is now focused on finalizing the design for the pivotal Phase III trial. The company anticipates regulatory alignment for a Phase III trial that will target accelerated approval, likely utilizing biopsy-based endpoints, which are standard for definitive MASH approval.
The planned Phase III trial is expected to utilize a higher dose, specifically 2.4 mg, building on the dose-dependent efficacy observed in the Phase IIb study. This strategic move aims to maximize both the liver health benefits and the weight loss potential of the drug, further strengthening its commercial profile.
The positive data on liver health markers (ELF, LSM, ALT, and cT1) underscores the potential of pemvidutide to address the underlying pathology of MASH, moving beyond simple weight reduction. As the MASH treatment market is rapidly evolving, the ability of pemvidutide to show significant, measurable improvements in fibrosis and stiffness markers provides a strong competitive edge against other candidates focused primarily on steatosis or weight loss alone.
The successful completion of the 48-week IMPACT trial marks a critical milestone for Altimmune, validating the drug's mechanism of action and setting the stage for its advancement into late-stage clinical development and potential commercialization.
