Improvements in collagen formation and degradation biomarkers indicate that efimosfermin reduces fibrotic activity, consistent with histopathology findings in participants with F2 and F3 MASH after 24 weeks of treatment
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Boston Pharmaceuticals, a clinical-stage biopharmaceutical company developing efimosfermin alfa, a once-monthly FGF21 analogue for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), today announced it will present results from an analysis of its Phase 2 study in participants with stage F2 and F3 fibrosis due to MASH. The findings will be presented at the European Association for the Study of the Liver (EASL) Congress 2025, May 7-10, in Amsterdam.
"In the analysis, efimosfermin demonstrated improvements in biomarkers related to collagen and a reduction in liver scarring among patients with moderate to advanced liver fibrosis (stages F2-F3) caused by metabolic dysfunction-associated steatotic liver disease," said Rohit Loomba, M.D., MHSc, Professor of Medicine and Chief of the Division of Gastroenterology and Hepatology at University of California, San Diego. “These data support the histology findings that efimosfermin may have promising effects in treating liver fibrosis in individuals with metabolic liver disease.”
As fibrosis progresses, the risk of liver-related morbidity and mortality increases in patients with MASH. This is associated with an imbalance in extracellular matrix (ECM) synthesis and degradation, leading to collagen accumulation in the liver. Improvements in collagen biomarkers over 24 weeks suggest that efimosfermin reduces fibrotic activity, shifting the balance from fibrogenesis to fibrolysis.
These results are consistent with histopathology findings presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in November 2024, which showed that treatment with once-monthly efimosfermin led to significant improvements in fibrosis ≥1 stage without worsening of MASH, and MASH resolution without worsening of fibrosis, compared to placebo over 24 weeks in participants with biopsy-confirmed F2/F3 MASH. Substantial and rapid improvements in cardiometabolic benefits, such as liver fat reduction and improved glycemic control, were also observed in MASH patients with obesity and diabetes. Efimosfermin was generally well tolerated in the Phase 2 study, with low discontinuation rates due to adverse events, and an overall low incidence of gastrointestinal side effects and injection site reactions.
“We are seeing clear and meaningful improvements in key cardiometabolic and liver biomarkers, as well as a reduction in fibrosis, which is critical for MASH patients,” said Sophie Kornowski, CEO of Boston Pharmaceuticals. “The continued positive data from our Phase 2 trial reinforces the promise of once-monthly efimosfermin as a transformative therapy for patients with MASH. We are encouraged by the strength of treatment response and the favorable safety profile observed in this trial, which positions us well for upcoming regulatory meetings. Our commitment to developing efimosfermin remains steadfast, and we are excited for the next steps in our journey to improve the lives of those living with this disease.”
Details of Boston Pharmaceuticals’ presentation at EASL Congress 2025 are as follows:
Oral Presentation Title: |
Efimosfermin alfa once monthly treatment improves collagen biomarker profiles and rapidly induces histological fibrosis regression in subjects with MASH stage F2-F3 fibrosis in a 24-week phase 2 trial |
Abstract Number: |
OS-012 |
Session Title: |
Abstract Session – MASLD: Clinical and therapeutical aspects |
Session Date, Time: |
Thursday, May 8, 5:00 p.m. – 6:15 p.m. CEST |
Location: |
De Groote Room |
Presenter: |
Rohit Loomba, M.D., MHSc, Professor of Medicine, Chief in the Division of Gastroenterology and Hepatology, and Director of MASLD Research Center at University of California, San Diego |
About MASH
Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), is a growing global epidemic fueled by the increasing prevalence of obesity and type 2 diabetes. It is estimated that MASH affects millions of people worldwide, including 17 million in the U.S., and is expected to increase by 63% by 2030. MASH is a progressive disease staged by the degree of fibrosis (scarring) in the liver and is closely associated with multiple cardiometabolic risk factors. Left untreated, MASH could lead to liver failure, liver cancer, or death. In the U.S., MASH is becoming the leading cause of liver transplantation.
About efimosfermin alfa
Boston Pharmaceuticals’ lead investigational agent, efimosfermin alfa, is a once-monthly subcutaneous injection of a long-acting variant of human fibroblast growth factor 21 (FGF21) that regulates various metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis in patients with MASH. Efimosfermin is manufactured in mammalian cells, leading to human-like glycosylation. Efimosfermin is currently in Phase 2 clinical trials for the treatment of MASH. In a 24-week Phase 2 study of subjects with moderate to advanced (stage F2 and F3) fibrosis due to MASH, efimosfermin has demonstrated statistically significant improvements in liver fibrosis and MASH resolution, reductions in liver fat content, improved markers of liver injury and metabolic biomarkers, with a favorable safety profile. The most frequently reported treatment-emergent adverse events were gastrointestinal events and were predominantly mild to moderate.
About Boston Pharmaceuticals
Boston Pharmaceuticals, a portfolio company of B-FLEXION, is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in serious liver diseases, with MASH as the focus of its lead asset. The Company has significant expansion opportunities through its portfolio of promising drug development candidates that were acquired through partnerships with proven, innovative biotechnology and pharmaceutical companies. Boston Pharmaceuticals applies rigorous decision-making to advance programs to deliver differentiated medicines to patients in need of new options while creating value for all parties involved in the journey.
For more information, please visit www.bostonpharmaceuticals.com and follow us on LinkedIn.
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. This communication, other than statements of historic fact, are forward-looking statements.
Boston Pharmaceutical’s actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory or prove to be commercially successful. Boston Pharmaceuticals does not undertake to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this presentation except as required by law.
Contacts
Media Contacts:
David Patti
DSP Pharma Communications, LLC
(908) 421-5971
dspcommsconsulting@gmail.com
Sasha Damouni Ellis
DSP Pharma Communications/Damouni Group, LLC
(646) 240-2311
sasha@damounigroup.com
Boston Pharmaceuticals
media@bostonpharmaceuticals.com
