Regulators in the U.S. and EU have given 89bio (NASDAQ:ETNB) the green light for the Phase 3 trials of pegozafermin, a potential treatment for nonalcoholic steatohepatitis (NASH), announced the company on Monday.
Following an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA), the company revealed that both U.S. and EU officials were aligned with their Phase 3 plans for pegozafermin, a synthetic version of fibroblast growth factor 21 (FGF21) used in the treatment of NASH.
89bio (ETNB) will move forward with the ENLIGHTEN-Cirrhosis trial for NASH patients with compensated cirrhosis (F4) and the ENLIGHTEN-Fibrosis trial for NASH patients with fibrosis stage F2-F3.
The company intends to commence the ENLIGHTEN-Cirrhosis trial in Q1 and the ENLIGHTEN-Fibrosis trial in Q2 of 2024. Additionally, 89bio (ETNB) plans to enroll a significant number of NASH patients who are currently on GLP-1 drugs such as Eli Lilly’s (LLY) Zepbound and Novo Nordisk’s (NVO) Wegovy across both studies, aiming to evaluate the benefits of adding pegozafermin to GLP-1 therapy.