BIO89-100 NASH clinical trial : US-based biopharma company 89Bio has initiated a proof of concept phase 1b/2a clinical trial for BIO89-100, its NASH drug in development, by screening the first patients.
The proof of concept trial will evaluate the glycoPEGylated analog of fibroblast growth factor 21 (FGF21) in patients with nonalcoholic steatohepatitis (NASH) or patients having nonalcoholic fatty liver disease (NAFLD) and high risk of NASH.
The NASH clinical trial is designed to evaluate BIO89-100’s safety, tolerability, and pharmacokinetic properties apart from making key imaging and biomarker assessments.
The multiple ascending dose-ranging study will involve 83 patients, who will be randomly grouped to receive weekly or alternate weekly subcutaneous dosing of BIO89-100 or placebo for up to 12 weeks. Variations from baseline in liver fat will be assessed, as measured by Magnetic Resonance Imaging – Proton Density Fat Fraction (MRI-PDFF), along with changes from baseline in lipid parameters, transaminases, and other pharmacodynamic parameters and biomarkers, said 89Bio.
Commenting on the NASH clinical trial, Hank Mansbach – 89bio chief medical officer, said: “We are pleased to advance our clinical development program for BIO89-100 with the initiation of this proof of concept trial following closely on our positive Phase 1a data announced in May.
“We believe that BIO89-100 has the potential to become a mainstay of NASH therapy by addressing both liver pathologies and the underlying metabolic dysregulation that results in NASH progression. BIO89-100 may also be well suited for extended interval dosing in patients, which could be a convenient option for patients in the treatment of a chronic condition.”
BIO89-100 was engineered using a glycoPEGylation technology designed to extend the biological activity of native FGF21. In preclinical studies, the NASH drug in development showed significant improvements in hepatic steatosis, injury, and fibrosis.
In a phase 1a NASH clinical trial in healthy volunteers, BIO89-100 showed a favorable tolerability profile and dose-proportional pharmacokinetics. The NASH drug in development also delivered statistically significant improvements in key lipid parameters for two weeks following a single dose, which backs the potential for once a week or once every two-week dosing.