89bio Outlines Roadmap For Pivotal Studies For Lead Program In Fatty Liver Disease

89bio Inc 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 enroll patients with fibrosis stage F2-F3 and will evaluate the efficacy and safety of pegozafermin administered 30mg weekly and 44mg every two weeks.
  • The co-primary endpoints will be a one-point improvement in fibrosis with no worsening of NASH and NASH resolution with no worsening of fibrosis.

The F2-F3 and the F4 trials are expected to initiate in Q1 and Q2 of 2024, respectively. Initial scientific advice received from EMA was generally aligned with the feedback from the FDA.

Both ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis will enroll a significant proportion of patients on stable doses of GLP-1 based therapies and data from these patients in the trials will evaluate the expected incremental benefit of adding pegozafermin to these therapies.

Last month, 89bio released topline data from the blinded extension phase of its Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in NASH patients.

At week 48, the 30mg weekly (QW) and 44mg every two weeks (Q2W) dosing schedules of pegozafermin demonstrated statistically significant improvements across key markers of liver health. 

Price Action: ETNB shares are up 6.79% at $8.97 on the last check Monday.