89bio biopsy results advance NASH candidate

Biopsy data from a cohort of 89Bio’s Phase I/IIa study suggest pegozafermin may address multiple mechanisms behind NASH, but the compound still faces the challenge of proving statistical significance in a placebo controlled study, a hurdle that has derailed other promising programs. 

89Bio Inc. (NASDAQ:ETNB) announced after hours on Monday that pegozafermin (BIO89-100), a long-acting glycopegylated FGF21 analog, led to a 2-point or greater improvement in the NAFLD activity score (NAS) without worsening fibrosis — the primary endpoint — in 63% of the 19 patients with stage F2 or F3 fibrosis in the study’s open-label expansion cohort. ...