CAMBRIDGE, Mass.--(BUSINESS WIRE)--Boston Pharmaceuticals today announced administration of BOS-580 to the first patient in a Phase 2a clinical trial in individuals with nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis (NAFLD and/or NASH). BOS-580 is designed to be a form of FGF21 that regulates various metabolic pathways to decrease liver fat and ameliorate liver inflammation and damage in patients with NASH.
“The dosing of the first patient with BOS-580 continues the momentum across our pipeline of innovative molecules in areas of important unmet medical need,” said Robert Armstrong, Ph.D., CEO of Boston Pharmaceuticals. “It also validates our approach to strategically and rapidly advance promising programs through clinical development as we relentlessly focus on bringing medicines that matter to patients.”
“NASH is a complex and potentially fatal disease,” said Craig T. Basson, M.D., Ph.D., Chief Medical Officer of Boston Pharmaceuticals. “FGF21 is an important therapeutic target for metabolic disorders including NASH due to its ability to restore whole-body metabolism. We look forward to evaluating BOS-580 and developing it into a promising therapy with unrivalled patient experience over similar analogs.”
The Phase 2a study is a 12-week treatment, randomized, blinded, placebo-controlled study in individuals with NAFLD and/or NASH. The objectives of the study are to assess the safety and tolerability of BOS-580 and evaluate the pharmacokinetics of the drug candidate. Subjects will be randomized to cohorts with different dose regimens and receive either BOS-580 or placebo by subcutaneous injection. Inclusion criteria includes a hepatic fat fraction (HFF) measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) > 10%. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04880031).
About BOS-580
BOS-580 is an injectable, genetically engineered 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 nonalcoholic steatohepatitis (NASH). BOS-580 has the potential to be a best-in-class FGF21 analog as it is designed to offer a better patient experience.
About Boston Pharmaceuticals
Boston Pharmaceuticals is a clinical stage biopharmaceutical company that leverages an experienced drug development team to advance a portfolio of high value candidates that address important unmet medical needs. The Company partners with innovative biotechnology and pharmaceutical companies to acquire drug development candidates. We adhere to a rigorous decision-making process, follow the data, and advance only those programs that meet our stringent development hurdles. We look to establish value creating partnerships with the world’s leading biotechnology and pharmaceutical companies that help advance programs to commercial stage. We are continuously seeking new opportunities to leverage our model to create a path to value for our patients and partners. Boston Pharmaceuticals is a portfolio company of Waypoint Capital, an investment firm based in Europe and focused on healthcare, medical technologies, and asset management. For more information, please visit www.bostonpharmaceuticals.com or follow us on Twitter @BosPharma and LinkedIn.
