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October 4, 2021

Boston initiates Phase IIa trial of drug candidate for NASH

The trial will assess the safety and tolerability of a subcutaneous dose of BOS-580 in NASH and NAFLD patients.

Boston Pharmaceuticals has commenced dosing of the first subject with its drug candidate, BOS-580, in a Phase IIa clinical trial in nonalcoholic fatty liver disease and/or nonalcoholic steatohepatitis (NAFLD and/or NASH) patients.

BOS-580 is a genetically designed form of human fibroblast growth factor 21 (FGF21) and is injectable.

It can adjust several metabolic pathways to lower liver fat and ameliorate liver inflammation as well as damage in NASH patients.

The randomised, placebo-controlled, blinded Phase IIa trial will treat the subjects for a duration of 12 weeks.

The trial aim to evaluate the safety, tolerability and pharmacokinetics of the drug.

Subjects will be categorised into groups to receive varying subcutaneous doses of either BOS-580 or placebo.

Hepatic fat fraction (HFF) assessed by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) greater than 10% will be a criterion for recruitment.

In addition, obese subjects with a body mass index (BMI) in the range of 30-45 kg/m^2 will be included in the trial.

Boston Pharmaceuticals CEO Robert Armstrong said: “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.

“It also validates our approach to strategically and rapidly advance promising programmes through clinical development as we relentlessly focus on bringing medicines that matter to patients.”

The trial plans to enrol a total of 75 adult subjects aged 18 to 75.

Boston Pharmaceuticals chief medical officer Craig Basson said: “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 analogues.”

In March this year, Boston Pharmaceuticals and GlaxoSmithKline entered a three-year out-license and option agreement to advance multiple pre-phase two programmes.

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