Boston Pharma Shows BOS-580 Improves Lipid Profiles in MASH at EASL 2024

Cambridge, Mass.—Boston Pharmaceuticals, a biopharmaceutical enterprise specializing in innovative treatments for serious liver conditions, has released encouraging Phase 2a study results, revealing the therapeutic potential of BOS-580. This investigational fibroblast growth factor 21 (FGF21) analogue, designed for long-term action, has demonstrated positive effects on the circulating lipidome and changes in the metabolomics advanced steatohepatitis fibrosis (MASEF) score in patients with phenotypic metabolic dysfunction-associated steatohepatitis (MASH). The findings are set to be presented at the European Association for the Study of the Liver (EASL) Congress 2024 from June 5-8 in Milan, Italy.

Key Findings and Implications

Sophie Kornowski, CEO of Boston Pharmaceuticals, highlighted that the circulating lipidome in patients with phenotypic MASH significantly differs from that of obese but otherwise healthy individuals. Over 12 weeks, treatment with BOS-580 notably improved the lipid profiles of these patients and decreased their MASEF scores—an innovative composite biomarker designed to identify at-risk MASH patients. Kornowski emphasized BOS-580's potential as a powerful, once-monthly treatment option for MASH and underscored the importance of diagnostic and predictive biomarkers in the management and assessment of MASH. She also mentioned that biopsy results from their ongoing study involving patients with stage F2/F3 fibrosis due to MASH would be shared later this year.

Analysis of Lipidome and MASEF Scores

Investigations into the lipidome changes in MASH patients suggest that lipid metabolism dysregulation is pivotal to the disease's progression, contributing to oxidative stress, inflammation, and cell death. Understanding lipid metabolism's role in both healthy and diseased states can aid in discovering biomarkers for diagnosis and identifying new therapeutic targets. The MASEF score, driven by metabolomics, provides a non-invasive method to pinpoint MASH patients who would benefit from medical intervention, making it a promising diagnostic tool.

In the detailed analysis, researchers assessed the variations in the lipidome of patients over a 12-week period of BOS-580 treatment. Participants were part of a randomized, double-blind, placebo-controlled Phase 2a study involving 102 patients. The results were substantial:

- BOS-580 treatment resulted in extensive changes in the circulating lipidome, including reduced levels of saturated fatty acids and triglycerides. Additionally, there was a significant reduction in lipotoxic molecules, such as diglycerides and ceramides, suggesting BOS-580's beneficial effects may be partly due to lowering these harmful molecules in MASH patients.

- 88% of patients treated with BOS-580 experienced reductions in their composite MASEF scores, compared to 33% in the placebo group.

- BOS-580 treatment also improved MASEF risk classification, reducing the percentage of patients at risk for MASH from 20% at the start to 2% after 12 weeks, while the placebo group saw an increase from 17% to 20%.

Presentation Details

Boston Pharmaceuticals will present these findings at the EASL Congress 2024 under the title: "BOS-580, a long-acting FGF21 analogue, treatment shows beneficial changes in the circulating lipidome and improves MASEF score in patients with phenotypic metabolic dysfunction-associated steatohepatitis in a Phase 2a randomized, placebo-controlled, 12-week study." The presentation is scheduled for June 5 at 8:30 am CEST, with Gerard Bain representing the company.

About Boston Pharmaceuticals

Boston Pharmaceuticals is committed to advancing a portfolio of unique therapies aimed at addressing critical unmet medical needs in serious liver diseases, focusing particularly on MASH. The company leverages its expertise and strategic partnerships with leading biotechnology and pharmaceutical firms to develop promising drug candidates. Boston Pharmaceuticals applies stringent decision-making processes to bring innovative medicines to patients who need new treatment options, thereby creating value for all stakeholders involved.

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