Long-acting FGF21 Analogue BOS-580 Shows Persistent Low Immunogenicity in MASH Treatment at NASH-TAG 2024

A recent Phase 2a study has brought promising news for individuals suffering from metabolic dysfunction-associated steatohepatitis (MASH), a condition also known as non-alcoholic steatohepatitis (NASH). The study focused on BOS-580, an innovative long-acting fibroblast growth factor 21 (FGF21) analogue developed by Boston Pharmaceuticals, a clinical-stage biopharmaceutical company. The research indicated that BOS-580 showed a low risk of triggering an immune response, which is a significant advantage in the development of treatments for MASH.

The study, presented at the NASH-TAG 2024 conference, revealed that BOS-580 treatment resulted in rapid and substantial decreases in biomarkers associated with fibrosis, a critical aspect of liver disease progression. The findings suggest that BOS-580 could become a cornerstone in the management of MASH, offering a convenient and compelling therapeutic option for affected patients.

Sophie Kornowski, CEO of Boston Pharmaceuticals, highlighted the importance of the low immunogenicity observed with BOS-580, stating that it is a distinguishing feature among FGF21 analogues in development. This characteristic is crucial as it allows for sustained efficacy without the risk of the body developing antibodies against the treatment.

The Phase 2a trial involved 102 patients with phenotypic MASH who were treated with BOS-580 using once-monthly and bi-weekly dosing regimens. The results showed that the drug elicited low and transient anti-drug antibody (ADA) responses, with only one out of 65 patients (1.5%) showing consecutive increasing anti-FGF21 antibodies. Importantly, these antibodies did not affect the drug's pharmacokinetic or pharmacodynamic parameters.

Furthermore, the analysis demonstrated that BOS-580 led to significant reductions in composite scores for various liver injury and fibrosis biomarkers, such as Fibroscan-AST (FAST), Fibrosis-4 Index (FIB-4), Aspartate aminotransferase-to-platelet ratio index (APRI), and ADAPT. These improvements were observed quickly, within one to two weeks, and were maintained throughout the 12-week study period.

The potential of BOS-580 to become a key component in the treatment of MASH is underscored by the commitment of Boston Pharmaceuticals to advance the drug to pivotal clinical trials. The company's focus on developing differentiated therapies for serious liver diseases, with MASH as the primary target, positions BOS-580 as a promising candidate in the fight against this debilitating condition.

Boston Pharmaceuticals, with its experienced drug development team, is dedicated to advancing a portfolio of therapies that address unmet medical needs in liver diseases. The company's strategy involves rigorous decision-making to progress programs that can deliver effective treatments to patients while creating value for all stakeholders.

The study's findings and the potential of BOS-580 underscore the importance of ongoing research and development efforts in the field of liver disease treatment. As the prevalence of MASH and related conditions continues to rise, the need for innovative and effective therapies becomes increasingly urgent. BOS-580 represents a significant step forward in this endeavor, offering hope to those affected by MASH and the broader spectrum of liver diseases.