ETNB - 89bio Outlines Roadmap For Pivotal Studies For Lead Program In Fatty Liver Disease | Benzinga
89bio Inc (NASDAQ: ETNB) announced a successful end-of-Phase 2 Meeting with the FDA supporting the advancement of pegozafermin into Phase 3 in nonalcoholic steatohepatitis (NASH).
The program will include two Phase 3 trials evaluating patients with NASH:
- ENLIGHTEN-Cirrhosis trial will enroll patients with compensated cirrhosis (F4) and will evaluate the efficacy and safety of pegozafermin administered 30mg weekly.
- The primary endpoint will be fibrosis regression from F4 to an earlier fibrosis stage.
- ENLIGHTEN-Fibrosis study will ...