CAMBRIDGE, Mass. — Boston Pharmaceuticals will present new findings from its Phase 2 study of efimosfermin alfa, a once-monthly FGF21 analogue for treating metabolic dysfunction-associated steatohepatitis (MASH), at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam. The data highlights efimosfermin’s effect on collagen biomarkers in patients with stage F2 and F3 fibrosis, suggesting a reduction in fibrotic activity and supporting previous histopathology results.
The analysis showed that efimosfermin improved key biomarkers tied to collagen formation and degradation, indicating a shift in liver fibrosis from fibrogenesis (scarring) toward fibrolysis (scar breakdown). This is significant for MASH patients, where advancing fibrosis increases the risk of liver-related complications and mortality.
“In this analysis, efimosfermin demonstrated improvements in collagen-related biomarkers and reduced liver scarring among patients with moderate to advanced fibrosis,” said Dr. Rohit Loomba, professor of medicine at the University of California, San Diego. “These biomarker results align with previous histology data, reinforcing efimosfermin’s potential in treating liver fibrosis in metabolic liver disease.”
The new findings build on earlier results presented at the American Association for the Study of Liver Diseases (AASLD) meeting in November 2024. That data showed that efimosfermin significantly improved fibrosis by at least one stage without worsening MASH, and in some cases resolved MASH without worsening fibrosis, over a 24-week period in patients with biopsy-confirmed F2/F3 MASH. Additional benefits included reductions in liver fat and improved glycemic control, especially among patients with obesity and diabetes.
Efimosfermin also demonstrated a favorable safety profile, with few adverse events leading to discontinuation and a low incidence of gastrointestinal issues or injection site reactions.
“We are seeing clear and meaningful improvements in both liver fibrosis and key cardiometabolic markers, which are crucial for MASH patients,” said Sophie Kornowski, CEO of Boston Pharmaceuticals. “The strength of the treatment response and the favorable safety profile position efimosfermin as a promising, once-monthly therapy for this challenging disease.”
Boston Pharmaceuticals plans to continue advancing efimosfermin into regulatory discussions later this year, with the new data further supporting its development as a potential transformative treatment for MASH.