Altimmune Showcases Pemvidutide Data at EASL 2024 for MASH Treatment

Altimmune, Inc., a clinical-stage biopharmaceutical company, has unveiled promising data on the anti-inflammatory and anti-fibrotic properties of pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH) at the EASL International Liver Congress™ 2024 in Milan, Italy. These findings, combined with results from the MOMENTUM Phase 2 obesity trial, demonstrate pemvidutide's potential to stand out from existing therapies targeting MASH and obesity due to its balanced GLP-1 and glucagon dual agonism.

Pemvidutide is currently being evaluated in the ongoing Phase 2b IMPACT trial in subjects with MASH. The drug's dual mechanism aims to achieve significant reductions in body weight, liver fat, and lipids, thereby addressing MASH and its associated co-morbidities. The promising results suggest that pemvidutide could have additive effects on MASH resolution and fibrosis improvement compared to GLP-1 alone.

The data presented at the congress included results from three abstracts. The first abstract, WED-212, detailed a 24-week, randomized, double-blind, placebo-controlled trial involving 64 subjects with metabolic dysfunction-associated steatotic liver disease (MASLD). The trial showed that up to 75% of subjects at intermediate-to-high risk of MASH progression had their risk reduced to low after 24 weeks of pemvidutide treatment, compared to just 25% in the placebo group. Additionally, 60% of subjects achieved significant reductions in MRI-PDFF and ALT scores, while none in the placebo group did. These simultaneous reductions are associated with a higher likelihood of MASH resolution.

The second abstract, WED-219, utilized a quantitative systems pharmacology (QSP) computational model to predict the effects of pemvidutide on MASH outcomes. The model, calibrated with clinical trial data, showed that pemvidutide could lead to complete resolution of MASH and a 1-point median improvement in fibrosis by Week 24. The inclusion of glucagon receptor agonism in addition to GLP-1 receptor agonism was predicted to result in additional reductions in liver fat content and NAFLD activity score compared to GLP-1 alone, highlighting the potential potency of glucagon receptor agonism on MASH fibrosis.

The third abstract, WED-251, focused on plasma lipidomic profiling in subjects with overweight or obesity treated with pemvidutide. The profiling showed significant decreases in serum lipids, including those associated with MASH and cardiovascular disease. Pemvidutide treatment was also linked to reduced bile acid dysregulation, a condition exacerbated by obesity and insulin resistance, key risk factors for MASH and MASLD.

Collectively, these findings bolster the disease-modifying potential of pemvidutide on MASH and its associated co-morbidities, including cardiovascular disease. The data presented reinforces the hypothesis that pemvidutide's dual receptor agonism could offer a differentiated therapeutic approach in treating MASH and obesity.

Pemvidutide is a novel, investigational drug in development for obesity and MASH. Its action on GLP-1 and glucagon receptors is believed to mimic the effects of diet and exercise, leading to weight loss, reduced liver fat, and improved serum lipid profiles. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH, underlining its potential as a significant therapeutic advancement in this field.

Altimmune, dedicated to developing next-generation peptide-based therapeutics, continues to evaluate pemvidutide in ongoing clinical trials, aiming to address the unmet medical needs in obesity and liver diseases like MASH.