89Bio’s NASH Hopes Hang On Demonstrating Best-In-Class FGF21 Profile

Recent entrants, including some big pharma players, threaten to make the fibroblast growth factor (FGF) analog class another crowded field of clinical development for non-alcoholic steatohepatitis, but 89bio Inc. thinks its mid-stage FGF21 analog could prove best in class with less frequent dosing than a Phase II FGF21 candidate at Bristol-Myers Squibb Co. and offer a better safety profile than NGM Biopharmaceuticals Inc.’s Phase IIb FGF19 analog.

Founded in Israel in May 2018 with the licensing of BIO89-100 (then called TEVA47948) from Teva, 89Bio now operates mainly out of San Francisco. It anticipates reporting out Phase IIa data for BIO89-100 in NASH during the second half of 2020 – the ongoing Phase Ib/IIa study is testing once-weekly and twice-weekly injectable dosing of the glycopegylated FGF21 analog