Latest news with #liverFibrosis
Medscape
02-06-2025
- General
- Medscape
Fibrosis-4 Index Finds New Role in Rheumatoid Arthritis
Up to 20% of patients with rheumatoid arthritis (RA) had abnormal fibrosis-4 (FIB-4) index values, reflecting an indeterminate to high risk for liver fibrosis; a significant correlation was seen with insulin resistance but not with disease activity. METHODOLOGY: Researchers conducted a cross-sectional study to calculate FIB-4 index values in patients with RA and assess their relationship with disease characteristics and cardiovascular comorbidities. They recruited 465 adults with RA (mean age, 55 years; 81% women) between 2019 and 2021, all of whom had a disease duration of at least 1 year and were taking ≤ 10 mg/day of prednisone or an equivalent dose. The FIB-4 index was calculated using an equation considering age, platelet count, and alanine aminotransferase and aspartate aminotransferase levels, with the risk for fibrosis classified as low, indeterminate, or high on the basis of defined cutoff values. Participants underwent evaluations for disease activity, complete lipid profiles, the presence of metabolic syndrome, anthropometric parameters, and insulin resistance using the Homeostatic Model Assessment, as well as carotid ultrasound to detect subclinical carotid atherosclerosis. Cardiovascular risk was estimated using t he Systematic Coronary Risk Evaluation-2 (SCORE2) tool. TAKEAWAY: SCORE2 classified 66% of patients with RA as having low cardiovascular risk, 28% as having moderate cardiovascular risk, and 6% as having high cardiovascular risk; the prevalence of cardiovascular risk factors was generally high. FIB-4 values indicated an indeterminate risk for fibrosis in 18% of patients with RA and a high risk in 1%, whereas 81% had a low risk. Several factors, including age ( P < .001), cardiovascular risk measured by SCORE2 ( P < .001), and metabolic syndrome ( P = .008), showed positive correlations with FIB-4 values; however, in multivariable analysis, the presence of hypertension, insulin resistance indices, and statin use maintained significant positive associations. < .001), cardiovascular risk measured by SCORE2 ( < .001), and metabolic syndrome ( = .008), showed positive correlations with FIB-4 values; however, in multivariable analysis, the presence of hypertension, insulin resistance indices, and statin use maintained significant positive associations. Disease activity (measured by multiple scores), acute phase reactants, and the presence of rheumatoid factor or anti–citrullinated protein antibodies showed no significant association with FIB-4 values, whereas the presence of erosions at recruitment was associated with FIB-4 ( P = .044). IN PRACTICE: "This index may serve as a surrogate marker for CV [cardiovascular] risk and insulin resistance in patients with RA," the authors concluded. SOURCE: This study was led by Iván Ferraz-Amaro, Hospital Doctor Negrín, Las Palmas de Gran Canaria, Spain. It was published online on May 21, 2025, in Rheumatology . LIMITATIONS: The cross-sectional design of this study prevented the establishment of causal relationships between variables. Data on hepatic ultrasound or liver biopsy were lacking. Information on cumulative methotrexate use was not collected. DISCLOSURES: This study was supported by a grant from Instituto de Salud Carlos III and additional funds from the European Union. Two authors reported receiving grants or research support and consultation fees from speaker bureaus associated with several pharmaceutical and healthcare companies, including AbbVie, Roche, and GSK.
Medscape
02-06-2025
- Business
- Medscape
Metabolic Issues May Affect Liver Fibrosis in Hepatitis B
Patients with untreated chronic hepatitis B who had metabolic comorbidities were at a higher risk for advanced liver fibrosis and were less likely to see improvement with antiviral therapy than those without such comorbidities. METHODOLOGY: Researchers investigated the association between the presence of concurrent metabolic comorbidities and the severity of liver fibrosis in 3179 patients with untreated chronic hepatitis B (median age, 37 years; 72.2% men) using data from two tertiary clinics in the Netherlands and Canada and six global clinical trials. All patients underwent an initial liver biopsy, and 1307 of the patients enrolled in the clinical trials underwent a second biopsy 48-72 weeks after starting antiviral therapy. Biopsies were analyzed by experienced pathologists. Advanced fibrosis was defined as having METAVIR stages F3-F4, and nonadvanced fibrosis as having METAVIR stages F0-F2. Progression or regression of fibrosis was determined by an increase or decrease in fibrosis of at least one METAVIR stage from baseline, respectively. The presence of metabolic comorbidities (overweight, hypertension, diabetes, and dyslipidemia) was assessed using chart reviews and patient histories. TAKEAWAY: At baseline, metabolic comorbidities were present in 54.8% of patients, and advanced fibrosis was present in 24.4% of patients. The presence of metabolic comorbidities was independently associated with an increased risk for advanced fibrosis (adjusted odds ratio [aOR] for one comorbidity, 1.115; aOR for two or more comorbidities, 1.627; P = .006). = .006). The presence of metabolic comorbidities was also independently associated with reduced odds of regression from advanced to nonadvanced fibrosis after initiating antiviral therapy (aOR for one comorbidity, 0.79; aOR for two or more comorbidities, 0.26; P = .025). = .025). Progression to advanced fibrosis during antiviral therapy was observed in 9.8% of patients with one metabolic comorbidity and 14.3% of those with two or more metabolic comorbidities compared with 4.6% of those without metabolic comorbidities ( P = .001). IN PRACTICE: 'These findings provide solid support for the recently published World Health Organization HBV [hepatitis B virus] guideline, which underlines the importance of identifying and managing metabolic comorbidities in CHB [chronic hepatitis B] patients, as these comorbidities increase the risk of fibrosis progression and HCC [hepatocellular carcinoma] development,' the study authors wrote. SOURCE: The study, led by Lisa M. van Velsen, MD, Department of Gastroenterology & Hepatology, Erasmus Medical Center in Rotterdam, the Netherlands, was published online in Clinical Gastroenterology and Hepatology . LIMITATIONS: Information on hepatic steatosis was unavailable for the clinical trial patients. The presence of metabolic comorbidities was determined on the basis of a retrospective review of medical histories and medications, potentially leading to underdiagnosis of the conditions. Changes or development of metabolic comorbidities during follow-up could not be accounted for. DISCLOSURES: This study was sponsored by the Foundation for Liver and Gastrointestinal Research, and the data for the analyses were shared by Roche and Gilead Sciences. Several authors reported receiving research support or grants, consulting and/or speaking fees, honoraria, or contracts from pharmaceutical and biotechnology companies, including Roche and Gilead Sciences. One author reported being employed by Roche, and two authors reported being employed by Gilead Sciences.
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)
National Post
14-05-2025
- Business
- National Post
GSK to acquire efimosfermin, a phase III-ready potential best-in-class specialty medicine to treat and prevent progression of steatotic liver disease (SLD)
Article content 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 Article content Article content CAMBRIDGE, Mass. — 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. Article content 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. Article content 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. Article content 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 Article content 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 Article content 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.' Article content 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.' Article content 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.' Article content 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. Article content 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. Article content 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. Article content For GSK, Evercore Partners International LLP is acting as exclusive financial advisor and Cleary Gottlieb Steen & Hamilton LLP as legal counsel. Article content For Boston Pharmaceuticals, Centerview Partners LLC is acting as exclusive financial advisor and Sullivan & Cromwell LLP as legal counsel. Article content 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. Article content About Boston Pharmaceuticals Article content 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. Article content About GSK Article content 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 Article content 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. Article content 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 Article content Article content Article content Article content Article content Contacts Article content GSK enquiries Article content 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) Article content 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) Article content Boston Pharma enquiries Article content Article content Article content
