Exhibit 99.1
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, December 4, 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.
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ENLIGHTEN-Cirrhosis, in patients with compensated F4 NASH: The trial will evaluate the
efficacy and safety of pegozafermin administered 30mg weekly. |
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Histology Portion: The primary endpoint will be regression of fibrosis from F4 to an earlier stage of
fibrosis. This endpoint is planned to be assessed at 24 months, with the potential to assess it earlier based on the evolving clinical and regulatory landscape. This primary endpoint is intended to support a filing for accelerated approval in the
United States and conditional approval in Europe in F4 patients. |
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Outcome Portion: Patients will continue to be treated in a blinded extension phase through clinical
outcome events that are expected to be predominantly decompensation events. Alignment with the FDA on modified definitions of some of these events could allow the trial to reach the final number of events more quickly and therefore accelerate the
timeline to trial readout. Positive results would support full approval in F4 patients and will also serve as confirmatory full approval in F2-F3 patients. |