89Bio starting Proof of Concept Trial for NASH therapy and announcing expansion of leadership team

August 9, 2019
89Bio, a clinical-stage biopharmaceutical company, today announced Thursday that the first patients have been screened in its proof of concept Phase 1b/2a clinical trial evaluating its investigational product candidate, BIO89-100, a glycoPEGylated analog of fibroblast growth factor 21 (FGF21), in NASH or patients with nonalcoholic fatty liver disease (NAFLD) and high risk of NASH.

Nonalcoholic fatty liver disease (NAFLD) is a condition in which excess fat is stored in your liver. Nonalcoholic steatohepatitis (NASH) is liver inflammation and damage caused by a buildup of fat in the liver. It may remain silent for years and be discovered only once severe liver damage has already taken place. Experts estimate that between 30 and 40 percent of adults in the United States have NAFLD, and about 3 to 12 percent of adults in the United States have NASH.

The trial is a multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose-ranging study in patients with NASH or patients with NAFLD, and high risk of NASH.  Eighty-three patients will be randomized to receive weekly or every other week subcutaneous dosing of BIO89-100 or placebo for up to 12 weeks.  Changes from baseline in liver fat will be assessed, as measured by Magnetic Resonance Imaging – Proton Density Fat Fraction (MRI-PDFF), as well as changes from baseline in lipid parameters, transaminases, and other pharmacodynamic parameters and biomarkers.

89Bio also announced expansion of its leadership team with the appointment of:

  • Ryan Martins joins 89bio as chief financial officer (CFO). He was CFO at privately held Revolution Medicines and prior to that was vice president, head of corporate strategy and investor relations at Ultragenyx. 

Ryan Martins, CFO 89Bio

  • Quoc Le-Nguyen joins 89bio as chief technical operations officer and head of quality.  Most recently, Mr. Le-Nguyen was senior vice president, global head of technical operations & quality for Aduro BioTech, and prior to that, he was vice president, manufacturing operations for Bayer Healthcare.
  • Dr. Chao-Yin Chen joins 89bio as vice president, biometrics and development strategy. Most recently, Dr. Chen was executive director, head of biostatistics at Ultragenyx. 

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