Boston Pharmaceuticals to Present State-of-the-Art Lecture and Poster for Once-monthly Efimosfermin Alfa at Digestive Disease Week® 2025

• Phase 2 data presentation expands on top-line findings, reinforcing efimosfermin as a potential best-in-class FGF21 treatment for MASH
  
  
• Efimosfermin clinical program to advance to Phase 3 pivotal study in fourth quarter of 2025

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Boston Pharmaceuticals, a clinical-stage biopharmaceutical company developing efimosfermin alfa, an investigational, once-monthly FGF21 analogue for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), today announced it will present immunogenicity and biomarker analyses from its Phase 2 study, in participants with stage F2 and F3 fibrosis due to MASH. The results will be presented in a state-of-the-art lecture and poster at Digestive Disease Week (DDW) in San Diego, May 3-6, 2025. These findings further support the advancement of the efimosfermin clinical program to a Phase 3 pivotal study in 2025.

“Efimosfermin has demonstrated rapid and strong response across liver and cardiometabolic biomarkers, along with a favorable safety and tolerability profile. Its once-monthly dosing is expected to be a significant advantage for both prescribers and patients, providing confidence that efimosfermin could set a new standard in MASH treatment,” said Sophie Kornowski, CEO of Boston Pharmaceuticals. “With our robust data, along with the commitment from our Board and a strong funding strategy, we aim to accelerate efimosfermin’s development and begin enrolling patients in a Phase 3 study in F2 and F3 patients before the end of the year, followed by an F4 trial after planned discussions with regulators.”

The state-of-the-art oral presentation will showcase results from the Phase 2, randomized, placebo-controlled, 24-week treatment study in participants with biopsy-confirmed F2 and F3 MASH. The study showed significant improvements in histopathology, with 45.2% (p=0.038) of participants treated with efimosfermin 300mg achieving fibrosis improvement ≥1 stage without worsening of MASH compared to 20.6% in the placebo group, and MASH resolution without worsening of fibrosis in 67.7% of participants (p=0.002) versus 29.4% at 24 weeks. Efimosfermin also demonstrated extrahepatic benefits, including positive impacts on lipids and in participants with diabetes, clinically meaningful improvements in glycemic control. In this study, efimosfermin was generally well-tolerated, with low discontinuation rates due to adverse events, and an overall low incidence of gastrointestinal side effects and injection site reactions. Data to be presented will also highlight the favorable immunogenicity profile of efimosfermin.

Exploratory analyses of the phase 2 study of changes in biomarkers that identify at-risk MASH patients will be presented as a poster. These results strengthen the histopathology findings, demonstrating rapid and marked effects on biomarkers of steatosis, fibrosis, and liver injury, and supports the potential of efimosfermin as a once-monthly, disease-modifying therapeutic for the treatment of MASH.

“These analyses further support the Phase 2 study findings and provides the scientific community with the confidence to advance the development of efimosfermin as a potential therapy for patients with F2 and F3 fibrosis,” said Mazen Noureddin, M.D., M.H.Sc., lead investigator and Professor of Medicine at Houston Methodist Hospital, and Director of the Houston Research Institute. “Based on these encouraging results, we expect to see continued progress as we evaluate findings across histology and non-invasive markers in patients with F2 and F3 MASH receiving efimosfermin treatment for up to 48 weeks.”

Details of Boston Pharmaceuticals’ presentations are as follows:

Digestive Disease Week 2025

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 now a leading cause of liver transplantation.

About efimosfermin alfa

Boston Pharmaceuticals’ lead investigational agent, efimosfermin alfa (formerly BOS-580) is a once-monthly subcutaneous injectable of a long-acting variant of human fibroblast growth factor 21 (FGF21) that regulates various metabolic pathways to decrease liver fat and ameliorate liver inflammation and damage in patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). The Phase 2 clinical development program of efimosfermin is continuing with an open-label extension in F2 and F3 MASH patients, providing an additional 24 weeks of treatment to assess long-term safety and efficacy up to 48 weeks. Boston Pharmaceuticals also plans to initiate a supplemental study in F4 MASH to further expand and enrich the data set for this patient population.

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.

Media:
David Patti
DSP Pharma Communications, LLC
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dspcommsconsulting@gmail.com

Sasha Damouni Ellis
DSP Pharma Communications/Damouni Group, LLC
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sasha@damounigroup.com

Boston Pharmaceuticals
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