Latest news with #Efimosfermin
Yahoo
14-05-2025
- Business
- Yahoo
GSK to spend $2bn on Phase III liver disease drug acquisition
Just a day after dropping a $625m cancer asset, GSK has inked a deal worth a potential $2bn to acquire Boston Pharmaceuticals' efimosfermin, a drug ready to hit Phase III trials for the treatment of liver disease. The UK big pharma company will pay $1.2bn upfront for Boston's subsidiary BP Asset IX, which will give the company access to efimosfermin. GSK has also agreed to pay additional milestone payments totalling $800m, along with tiered royalties to Novartis, which originally owned the therapy. Shares in London-listed GSK opened relatively unchanged following the news, though climbed into the mid-morning to a share price high of £1,382.00 (correct at 11am GMT+1). The company has a market cap of £56.98bn. Efimosfermin is being developed to treat and prevent the progression of steatotic liver disease (SLD), a build-up of fat in liver cells. SLD is a broad disease term used to encompass various causes of fat accumulation in the liver. If untreated, fat build-up in cells can progress to more severe stages that include fibrosis and cirrhosis. GSK's new asset is taken once monthly via a subcutaneous injection. Efimosfermin is a long-acting variant of fibroblast growth factor 21 (FGF21) that is designed to regulate key metabolic pathways to decrease both liver fat and inflammation, and reverse liver fibrosis. The therapy has already performed well in a Phase II trial (NCT06920043) in patients with moderate-to-advanced (F2 or F3) metabolic dysfunction-associated steatohepatitis (MASH), a form of SLD. Data, posted by Boston in November 2024, demonstrated that efimosfermin has 'significant therapeutic potential' in liver disease. Of the 31 patients receiving the injection, 14 had a one-stage or greater improvement in fibrosis without MASH progression, compared to just seven out of 34 in the placebo group. Whilst there are other FGF21 drugs in development – such as Akero Therapeutics efruxifermin and 89bio's pegozafermin – Boston designed efimosfermin with an extended half-life to allow monthly dosing while Akero and 89bio's assets require weekly dosing, GSK's drug could be set for an early market advantage. GSK has also earmarked efimosfermin's potential to combine with its in-house siRNA therapeutic GSK'990 to address more advanced stages of SLD. According to GlobalData estimates, the MASH market is anticipated to reach sales of $25.7bn in 2032 across the seven major markets (7MM: US, France, Germany, Italy, Spain, the UK, and Japan). The market was revived in March 2024 when Madrigal Pharmaceuticals' Rezdiffra (resmetirom) won the first US Food and Drug Administration (FDA) approval for a MASH treatment. GlobalData noted an increase in drug partnership deal values in the MASH arena in 2024. Eli Lilly continued this trend into this year when it agreed to pay $630m for a Phase I RNA-based candidate from South Korea-based biotech OliX Pharmaceuticals in February 2025. GSK said the purchase of Boston's drug aligns with its R&D focus on 'science related to the immune system'. The deal agreement comes just a day after the drugmaker dropped an anti-TIGIT antibody it previously attained the rights for in a $625m upfront deal. GSK's chief scientific officer Tony Wood said: 'Efimosfermin will significantly expand our hepatology pipeline and provide us the opportunity to develop a new potential best-in-class medicine with its first launch expected in 2029. It complements GSK'990, also in development for alcohol-related liver disease and MASH, offering GSK options to develop both monotherapy and potential combinations to improve patient outcomes.' "GSK to spend $2bn on Phase III liver disease drug acquisition" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Times
14-05-2025
- Business
- Times
GSK makes $2bn bet on liver drug from US biotech
GSK, one of Britain's biggest pharmaceutical companies, has agreed to pay up to $2 billion for a promising liver disease drug in the latest bolt-on acquisition to strengthen its drugs pipeline. The FTSE 100 company will acquire the lead asset of Boston Pharmaceuticals, an American biopharma company, which is due to enter late-stage clinical trials and a potential 'best-in-class' blockbuster. Efimosfermin is being developed as a once-monthly injection to both treat and prevent progression of steatotic liver disease, where patients suffer from an accumulation of fat in the liver and inflammation and fibrosis. Scientists believe the drug has the potential to combat more advanced stages of the disease and will complement an existing drug being developed internally by GSK, including as a potential combination.
Yahoo
14-05-2025
- Business
- Yahoo
GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD)
Affecting up to 5% of the global population, SLD represents an area of significant unmet medical need with limited treatment options Phase II data show potential of efimosfermin to reverse liver fibrosis, demonstrated in metabolic dysfunction-associated steatohepatitis (a form of SLD) Unique properties offer potential for efimosfermin to be a new standard-of-care Significantly expands GSK's hepatology pipeline aimed at addressing steatotic and viral drivers of liver disease, offering multiple development options and potential first launch in 2029 CAMBRIDGE, Mass., May 14, 2025--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) and Boston Pharmaceuticals, a leading clinical stage biopharmaceutical company developing highly targeted therapies for patients with serious liver diseases, today announced that they have entered into an agreement under which GSK will acquire Boston Pharmaceuticals' lead asset, efimosfermin alfa. Efimosfermin is a phase III-ready, potential best-in-class, investigational specialty medicine to treat and prevent progression of steatotic liver disease (SLD). Under the agreement, GSK will pay $1.2 billion upfront, with potential for additional success-based milestone payments totalling $800 million. Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and future development in alcohol-related liver disease (ALD), both forms of SLD. Given efimosfermin's direct antifibrotic mechanism of action and GSK's data-driven insights from work in human genetics and disease phenotyping, it has potential to address more advanced stages of SLD and opportunity in combination with GSK'990, a siRNA therapeutic in development for other subsets of patients with SLD. The acquisition of efimosfermin is highly aligned to GSK's R&D focus on science related to the immune system and is further evidence of the company's intent to build on its deep understanding of fibrosis and auto-inflammation to develop precision interventions that stop and reverse disease progression. SLD represents an area of significant unmet medical need affecting approximately 5% of the global population with limited therapeutic options for patients.1 SLD, including MASH and ALD, is characterised by the accumulation of fat in the liver (steatosis), with associated inflammation and fibrosis. ALD affects about 26 million patients globally, and together with MASH, is the leading cause of liver transplant in the US, representing a significant burden and cost on healthcare utilisation.1,3 Substantial and disproportionate costs are associated with end-stage liver disease. Interventions that reduce moderate-to-advanced fibrosis to prevent progression of cirrhosis, liver cancer, hospitalisations and transplant could save the US healthcare system between $40 - 100 billion over the next two decades.4 Recent data from a phase II trial of efimosfermin, designed to assess the efficacy and safety of a monthly subcutaneous dose in participants with biopsy-confirmed moderate-to-advanced (F2 or F3) MASH, showed that efimosfermin rapidly and significantly reversed liver fibrosis and stopped its progression, with a manageable tolerability profile. These data suggest potentially greater fibrosis improvement compared to that seen with other therapeutic approaches and with benefit expected independent of background glucagon-like peptide-1 (GLP-1) therapy. In addition, efimosfermin could offer triglyceride reduction and improved glycaemic control, important considerations for MASH patients who frequently face cardiometabolic co-morbidities. Efimosfermin's unique properties, including low immunogenicity and an extended half-life, also offer the potential for a monthly dosing regimen and improved patient convenience. Full data from the trial was presented at the American Association for the Study of Liver Diseases (AASLD) Meeting in November 2024.5 Tony Wood, Chief Scientific Officer, GSK said: "The FGF21 class has shown some of the most exciting data in MASH including first-in-disease evidence of cirrhosis reversal, and efimosfermin has the potential to define a new standard-of-care with its monthly dosing and tolerability profile. Efimosfermin will significantly expand our hepatology pipeline and provide us the opportunity to develop a new potential best-in-class medicine with first launch expected in 2029. It complements GSK'990, also in development for ALD and MASH, offering GSK options to develop both monotherapy and potential combinations to improve patient outcomes." Elias Zerhouni MD, Chair of the Board, Boston Pharmaceuticals, said: "I am very proud of today's agreement with GSK, a company I know and admire, and of the outstanding work of the Boston Pharmaceuticals team led by Sophie Kornowski. Notably, this would not have been possible without the impressive, sustained and long-term strategic commitment to leading edge science and biotechnology ventures of the Bertarelli family, which led to the development of our Efimosfermin alfa as a potential best-in-class therapy in its therapeutic field. We are delighted that GSK, a global leader, recognized Efimosfermin's potential to address a growing global public health concern and unmet medical need. Together, we look forward to Efimosfermin alfa's ongoing journey to become a best-in-class treatment for patients with SLD." Sophie Kornowski Pharm D, Chief Executive Officer, Boston Pharmaceuticals said: "Today marks a pivotal moment for Boston Pharmaceuticals and Efimosfermin alfa, as we begin a new chapter with GSK, a global organization with proven expertise in liver disease, and a shared commitment to patients. Our accomplishments were made possible thanks to the dedicated Boston Pharmaceuticals team, who focused on our mission to develop Efimosfermin with a great sense of urgency. I am especially grateful to Ernesto Bertarelli for his unflinching support and the commitment of his expertise over the last few years." The addition of efimosfermin further strengthens GSK's hepatology pipeline of specialty medicines aimed at addressing both viral (chronic hepatitis B) and steatotic (SLD) drivers of fibrotic liver diseases. Financial considerations Under the terms of the agreement, GSK will acquire BP Asset IX, Inc., a subsidiary of Boston Pharmaceuticals, to access efimosfermin. GSK will pay up to $2 billion of total cash consideration, comprising an upfront payment of $1.2 billion and up to $800 million in success-based milestone payments. GSK will also be responsible for success-based milestone payments as well as tiered royalties for efimosfermin owed to Novartis Pharma AG. GSK will account for the transaction as a business combination. This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. For GSK, Evercore Partners International LLP is acting as exclusive financial advisor and Cleary Gottlieb Steen & Hamilton LLP as legal counsel. For Boston Pharmaceuticals, Centerview Partners LLC is acting as exclusive financial advisor and Sullivan & Cromwell LLP as legal counsel. About efimosfermin alfa Efimosfermin is an investigational, once-monthly subcutaneous injection of a long-acting variant of FGF21 that is designed to regulate key metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis in patients with MASH. Efimosfermin is currently in trials for moderate to advanced fibrosis, including cirrhosis and is not available for prescription anywhere in the world. About Boston Pharmaceuticals Boston Pharmaceuticals 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. Boston Pharmaceuticals is a portfolio company of B-Flexion, a private, entrepreneurial investment firm which manages the combined funds and investments associated with the Bertarelli family and also partners with sophisticated capital to meet the shared goal of delivering exceptional value over the generations, while also contributing positively to society. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. Registered in England & Wales:No. 3888792 Registered Office:79 New Oxford StreetLondonWC1A 1DG References1 Global Burden of Disease Study 2017 Cirrhosis collaborators. 20202 Allen et al. Postgraduate Medicine. 2024, Vol 136, No. 3, 229–245.3 Younossi et al. Hepatol Commun. 2023 Dec 22;8(1):e03524 Wallace, Carolyn et al. Journal of Hepatology, Volume 0, Issue 05 Hepatology (2004) Late-Breaking Abstract Supplement p28-30 TLM2024LBA_20241115A.pdf View source version on Contacts GSK enquiries Media:Tim Foley +44 (0) 20 8047 5502 (London)Sarah Clements +44 (0) 20 8047 5502 (London)Kathleen Quinn +1 202 603 5003 (Washington DC)Lyndsay Meyer +1 202 302 4595 (Washington DC) Investor Relations:Constantin Fest +44 (0) 7831 826525 (London)James Dodwell +44 (0) 20 8047 2406 (London)Mick Readey +44 (0) 7990 339653 (London)Steph Mountifield +44 (0) 7796 707505 (London)Jeff McLaughlin +1 215 751 7002 (Philadelphia)Frannie DeFranco +1 215 751 4855 (Philadelphia) Boston Pharma enquiries Media: Sasha Damouni Ellis +1 (646) 240 2311; sasha@ (New York)David Patti +1 (908) 421 5971; dpatti@ (New York) B-Flexion enquiries Media: Blair Hennessy +1 (646) 757 0632; (New York)Emma Prenn-Vasilakis +1 (917) 763 6685; (Boston) Sign in to access your portfolio
Business Wire
14-05-2025
- Business
- Business Wire
GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) and Boston Pharmaceuticals, a leading clinical stage biopharmaceutical company developing highly targeted therapies for patients with serious liver diseases, today announced that they have entered into an agreement under which GSK will acquire Boston Pharmaceuticals' lead asset, efimosfermin alfa. Efimosfermin is a phase III-ready, potential best-in-class, investigational specialty medicine to treat and prevent progression of steatotic liver disease (SLD). Under the agreement, GSK will pay $1.2 billion upfront, with potential for additional success-based milestone payments totalling $800 million. Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), including cirrhosis, and future development in alcohol-related liver disease (ALD), both forms of SLD. Given efimosfermin's direct antifibrotic mechanism of action and GSK's data-driven insights from work in human genetics and disease phenotyping, it has potential to address more advanced stages of SLD and opportunity in combination with GSK'990, a siRNA therapeutic in development for other subsets of patients with SLD. The acquisition of efimosfermin is highly aligned to GSK's R&D focus on science related to the immune system and is further evidence of the company's intent to build on its deep understanding of fibrosis and auto-inflammation to develop precision interventions that stop and reverse disease progression. SLD represents an area of significant unmet medical need affecting approximately 5% of the global population with limited therapeutic options for patients. 1 SLD, including MASH and ALD, is characterised by the accumulation of fat in the liver (steatosis), with associated inflammation and fibrosis. ALD affects about 26 million patients globally, and together with MASH, is the leading cause of liver transplant in the US, representing a significant burden and cost on healthcare utilisation. 1,3 Substantial and disproportionate costs are associated with end-stage liver that reduce moderate-to-advanced fibrosis to prevent progression of cirrhosis, liver cancer, hospitalisations and transplant could save the US healthcare system between $40 - 100 billion over the next two decades. 4 Recent data from a phase II trial of efimosfermin, designed to assess the efficacy and safety of a monthly subcutaneous dose in participants with biopsy-confirmed moderate-to-advanced (F2 or F3) MASH, showed that efimosfermin rapidly and significantly reversed liver fibrosis and stopped its progression, with a manageable tolerability profile. These data suggest potentially greater fibrosis improvement compared to that seen with other therapeutic approaches and with benefit expected independent of background glucagon-like peptide-1 (GLP-1) therapy. In addition, efimosfermin could offer triglyceride reduction and improved glycaemic control, important considerations for MASH patients who frequently face cardiometabolic co-morbidities. Efimosfermin's unique properties, including low immunogenicity and an extended half-life, also offer the potential for a monthly dosing regimen and improved patient convenience. Full data from the trial was presented at the American Association for the Study of Liver Diseases (AASLD) Meeting in November 2024. 5 Tony Wood, Chief Scientific Officer, GSK said: 'The FGF21 class has shown some of the most exciting data in MASH including first-in-disease evidence of cirrhosis reversal, and efimosfermin has the potential to define a new standard-of-care with its monthly dosing and tolerability profile. Efimosfermin will significantly expand our hepatology pipeline and provide us the opportunity to develop a new potential best-in-class medicine with first launch expected in 2029. It complements GSK'990, also in development for ALD and MASH, offering GSK options to develop both monotherapy and potential combinations to improve patient outcomes.' Elias Zerhouni MD, Chair of the Board, Boston Pharmaceuticals, said: 'I am very proud of today's agreement with GSK, a company I know and admire, and of the outstanding work of the Boston Pharmaceuticals team led by Sophie Kornowski. Notably, this would not have been possible without the impressive, sustained and long-term strategic commitment to leading edge science and biotechnology ventures of the Bertarelli family, which led to the development of our Efimosfermin alfa as a potential best-in-class therapy in its therapeutic field. We are delighted that GSK, a global leader, recognized Efimosfermin's potential to address a growing global public health concern and unmet medical need. Together, we look forward to Efimosfermin alfa's ongoing journey to become a best-in-class treatment for patients with SLD.' Sophie Kornowski Pharm D, Chief Executive Officer, Boston Pharmaceuticals said: 'Today marks a pivotal moment for Boston Pharmaceuticals and Efimosfermin alfa, as we begin a new chapter with GSK, a global organization with proven expertise in liver disease, and a shared commitment to patients. Our accomplishments were made possible thanks to the dedicated Boston Pharmaceuticals team, who focused on our mission to develop Efimosfermin with a great sense of urgency. I am especially grateful to Ernesto Bertarelli for his unflinching support and the commitment of his expertise over the last few years." The addition of efimosfermin further strengthens GSK's hepatology pipeline of specialty medicines aimed at addressing both viral (chronic hepatitis B) and steatotic (SLD) drivers of fibrotic liver diseases. Financial considerations Under the terms of the agreement, GSK will acquire BP Asset IX, Inc., a subsidiary of Boston Pharmaceuticals, to access efimosfermin. GSK will pay up to $2 billion of total cash consideration, comprising an upfront payment of $1.2 billion and up to $800 million in success-based milestone payments. GSK will also be responsible for success-based milestone payments as well as tiered royalties for efimosfermin owed to Novartis Pharma AG. GSK will account for the transaction as a business combination. This transaction is subject to customary conditions, including applicable regulatory agency clearances under the Hart-Scott-Rodino Act in the US. For GSK, Evercore Partners International LLP is acting as exclusive financial advisor and Cleary Gottlieb Steen & Hamilton LLP as legal counsel. For Boston Pharmaceuticals, Centerview Partners LLC is acting as exclusive financial advisor and Sullivan & Cromwell LLP as legal counsel. About efimosfermin alfa Efimosfermin is an investigational, once-monthly subcutaneous injection of a long-acting variant of FGF21 that is designed to regulate key metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis in patients with MASH. Efimosfermin is currently in trials for moderate to advanced fibrosis, including cirrhosis and is not available for prescription anywhere in the world. About Boston Pharmaceuticals Boston Pharmaceuticals 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. Boston Pharmaceuticals is a portfolio company of B-Flexion, a private, entrepreneurial investment firm which manages the combined funds and investments associated with the Bertarelli family and also partners with sophisticated capital to meet the shared goal of delivering exceptional value over the generations, while also contributing positively to society. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the 'Risk Factors' section in GSK's Annual Report on Form 20-F for 2024, and GSK's Q1 Results for 2025. Registered in England & Wales: No. 3888792 Registered Office: 79 New Oxford Street London WC1A 1DG References 1 Global Burden of Disease Study 2017 Cirrhosis collaborators. 2020 2 Allen et al. Postgraduate Medicine. 2024, Vol 136, No. 3, 229–245. 3 Younossi et al. Hepatol Commun. 2023 Dec 22;8(1):e0352 4 Wallace, Carolyn et al. Journal of Hepatology, Volume 0, Issue 0 5 Hepatology (2004) Late-Breaking Abstract Supplement p28-30 TLM2024LBA_20241115A.pdf
Business Wire
23-04-2025
- Business
- Business Wire
Boston Pharmaceuticals to Present State-of-the-Art Lecture and Poster for Once-monthly Efimosfermin Alfa at Digestive Disease Week ® 2025
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., 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 Oral Presentation Title: Once-Monthly Efimosfermin Alfa (BOS-580) in Metabolic Dysfunction-Associated Steatohepatitis With F2/F3 Fibrosis: Results From a 24 Week, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial Abstract Number: 723 Session: State-of-the-Art Lecture: Update on MASLD Therapies Pipeline Session Date, Time: Monday, May 5, 2025, 10:00 a.m. – 11:30 a.m. PDT Presentation Time: 11:05 a.m. – 11:20 a.m. PDT Location: 6F Presenter: Matthew Bryant, PharmD, Vice President of Medical Affairs, Boston Pharmaceuticals Expand Poster Presentation Title: Once-Monthly Efimosfermin Alfa Improves FAST and FIB-4 Composite Biomarker Scores for MASH Stage F2-F3 Fibrosis in a 24-Week Phase 2 Trial Abstract Number: Sa1504 Session: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH) Session Date, Time: Location: Halls C-E 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 Expand 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 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.
