View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
October 4, 2021updated 11 Jul 2022 2:47pm

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.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena