89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024
—Alignment reached on key elements of the NASH development strategy, including accelerated approval pathway for both F4 and F2-F3 NASH patients using histology—
—Outcomes trial in F4 cirrhotic NASH patients expected to support full approval across F2-F4 NASH; potential to accelerate timeline to outcomes readout based on agreement with FDA on modified definition of some events—
—Safety database will be inclusive of data from the ongoing SHTG Phase 3 program—
—Trials to include patients on background GLP-1 therapy to assess potential of combination with pegozafermin—
SAN FRANCISCO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced a successful end-of-Phase 2 Meeting with the U.S. Food & Drug Administration (FDA), supporting the advancement of pegozafermin into Phase 3 in NASH. The program will include two Phase 3 trials evaluating patients with NASH: ENLIGHTEN-Cirrhosis will enroll patients with compensated cirrhosis (F4) and ENLIGHTEN-Fibrosis will enroll patients with fibrosis stage F2-F3. The F2-F3 and the F4 trials are expected to initiate in the first quarter and the second quarter of 2024, respectively. Initial scientific advice received from EMA was generally aligned with the feedback from the FDA.
“We are pleased to have achieved alignment with both regulatory agencies on the development path forward for pegozafermin in NASH, featuring an innovative clinical trial approach in F4 patients,” said Hank Mansbach, Chief Medical Officer of 89bio. “Importantly, the FDA has agreed to an accelerated approval pathway in F4 patients using histology and for the outcomes portion of the trial, has agreed to modified definitions of some clinical outcomes, which could potentially expedite the timeline to readout. The agency also agreed to a trial in F2-F3 patients using histology as an endpoint for accelerated approval. Furthermore, the agency supported our strategy to leverage safety data from our ongoing SHTG Phase 3 program, eliminating the need for a separate safety study.”
The planned ENLIGHTEN program will be comprised of two randomized, double-blinded, placebo-controlled Phase 3 trials, evaluating the efficacy and safety of pegozafermin in patients with NASH.
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. Both trials will employ the three-panel consensus biopsy reading methodology, which was successfully utilized in the ENLIVEN trial, for both baseline and primary endpoint biopsy reads. Patients will self-administer pegozafermin using the planned commercial liquid formulation delivered as a single subcutaneous injection.