Altimmune Publishes Pemvidutide Study on MASLD in Journal of Hepatology

In recent findings published in the Journal of Hepatology, Altimmune, Inc., a clinical-stage biopharmaceutical company, announced promising results from a 12-week clinical study of pemvidutide. This investigational GLP-1/glucagon dual receptor agonist has shown significant potential in treating metabolic dysfunction-associated steatotic liver disease (MASLD).

Metabolic dysfunction-associated steatohepatitis (MASH) is a severe liver disorder affecting a significant portion of the global adult population. It is estimated that 25% of adults worldwide suffer from MASLD, and between 20% and 30% of these patients progress to MASH. The study's results highlight the critical need for effective treatments for this widespread condition.

Pemvidutide’s performance in the study demonstrated its impressive efficacy. The trial included 94 participants who were either obese or overweight, each with a liver fat content (LFC) of 10% or higher. The participants were randomly assigned to receive varying doses of pemvidutide (1.2 mg, 1.8 mg, and 2.4 mg) or a placebo, administered weekly via subcutaneous injections over 12 weeks. Notably, the study did not incorporate any diet or exercise interventions, isolating the effects of pemvidutide.

The primary efficacy endpoint of the study was the relative reduction in LFC from baseline. Pemvidutide recipients experienced up to a 68.5% reduction in liver fat content, while those on the placebo saw only a 4.4% reduction. Additionally, an impressive 94.4% of those treated with pemvidutide achieved at least a 30% reduction in LFC, a key indicator of MASH resolution, compared with just 4.2% in the placebo group. Furthermore, up to 55.6% of pemvidutide recipients achieved normalization of their liver fat content (defined as LFC ≤5%), compared to none in the placebo group.

The benefits of pemvidutide extended beyond liver fat reductions. Participants also saw significant decreases in body weight and markers of liver inflammation, such as alanine aminotransferase (ALT) levels and corrected T1 (cT1) MRI imaging results. Importantly, the treatment was well-tolerated, with only a 2.9% rate of adverse event discontinuations among those receiving pemvidutide and no severe or serious adverse events reported.

Altimmune’s Chief Medical Officer, Dr. Scott Harris, expressed enthusiasm about the findings, noting that pemvidutide has shown the capability to significantly reduce liver fat, body weight, and hepatic inflammatory activity. This suggests its potential as a potent treatment for MASH and obesity. Unlike other therapies that may lack glucagon activity, pemvidutide directly affects hepatic fat metabolism, which could lead to more substantial reductions in liver fat than weight loss alone.

Pemvidutide is undergoing further evaluation in the Phase 2b IMPACT trial, focusing on subjects with MASH, with data expected to be available in early 2025. The U.S. FDA has granted Fast Track designation to pemvidutide for MASH treatment, underscoring the urgency and importance of developing effective therapies for this condition.

Altimmune continues to focus on innovative peptide-based therapeutics with the potential to address significant medical needs. The company's ongoing research and development efforts, including pemvidutide, highlight its commitment to providing transformative solutions for conditions like obesity and MASH.