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

 
• By Joseph Haas

89Bio thinks its Phase II FGF21 analog could prove best-in-class in NASH due to a longer half-life than Bristol’s pegbelfermin, and avoid the LDL-increasing effects seen with NGM’s FGF19 analog.

competition
89Bio cites multiple reasons why its FGF21 analog for NASH might be best in class

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

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