BIO89_100



NAME OF DRUG : BIO89_100

ALSO KNOWN AS : BIO89_100

LABORATORY : 89BIO

STATUS AND ADVANCEMENT

Type of drug : glycopegylated FGF21 analogue

Clinical trials advancement : Initiating Phase 2a

Estimated time to market : 115 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.

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