NAME OF DRUG : BIO89_100
ALSO KNOWN AS : TEV_47948
LABORATORY : 89BIO
STATUS AND ADVANCEMENT
Type of drug : glycopegylated FGF21 analogue
Clinical trials advancement : Initiating Phase 2a
Estimated time to market : 118 months.
LABORATORY ABSTRACT ON THE DRUG
BIO89-100 is a novel long-acting glycopegylated FGF21 analogue for the treatment of NASH. It was engineered using a proprietary glycopegylation technology to prolong the biological activity of native FGF21. In preclinical studies BIO89-100 demonstrated significant improvements in body weight, liver fat, hepatic injury and fibrosis, and biomarkers including triglycerides, LDL and HDL cholesterol, and glycemic control parameters. Additional details of BIO89-100 preclinical data can be found in this late-breaking poster presentation from the EASL International Liver Congress™. In a Phase 1 clinical trial in healthy volunteers, BIO89-100 demonstrated a favorable safety and biomarker profile and predictable pharmacokinetic profile. BIO89-100 also demonstrated robust and durable improvements in key lipid parameters after a single dose which supports the potential for once a week or once every two-week dosing.