89Bio

89Bio is a clinical-stage biopharmaceutical company focused on developing therapies for nonalcoholic steatohepatitis (NASH), a severe form of non-alcoholic fatty liver disease characterized by liver inflammation and fibrosis. The company's lead product candidate is pegozafermin, a long-acting glycopegylated analog of the hormone fibroblast growth factor 21 (FGF21). Pegozafermin is being developed for the treatment of NASH and severe hypertriglyceridemia (SHTG), a condition characterized by elevated levels of triglycerides in the blood.

Pegozafermin acts by targeting the FGF21 receptor, composed of co-receptors FGFR1c, FGFR2c, FGFR3c, and KLB. It is administered subcutaneously, and its glycopegylation technology helps extend its half-life, allowing for extended dosing intervals. In clinical trials, pegozafermin has demonstrated direct anti-fibrotic and anti-inflammatory effects on the liver, reduced triglyceride levels, improved insulin resistance and glycemic control, and a favorable safety and tolerability profile.

The company's Phase 2 billion ENLIVEN trial evaluated pegozafermin in NASH patients with fibrosis stages F2-F4. Both the 30mg weekly and 44mg every-two-week doses achieved statistically significant improvements in the primary histology endpoints at week 24, including resolution of NASH without worsening of fibrosis and at least a one-stage decrease in fibrosis without worsening of NASH. Long-term data at week 48 demonstrated sustained benefits across key markers of liver health and fibrosis. The US Food and Drug Administration (FDA) granted pegozafermin Breakthrough Therapy Designation for the treatment of NASH with fibrosis in September 2023.