89bio Initiates Phase 2b ENLIVEN Trial of BIO89-100 for the Treatment of NASH
SAN FRANCISCO, June 10, 2021 (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 cardio-metabolic diseases, today announced the initiation of ENLIVEN, a Phase 2b trial evaluating BIO89-100 for the treatment of patients with fibrosis stage 2 or 3 non-alcoholic steatohepatitis (NASH). 89bio is also pleased to announce that a distinguished group of clinicians and scientists will provide their deep expertise and valuable insight as part of the steering committee for ENLIVEN.
“We are pleased to initiate the ENLIVEN trial, an important milestone in our clinical development program for NASH,” said Hank Mansbach, Chief Medical Officer of 89bio. “ENLIVEN is a well-powered trial that builds on positive data from the Phase 1b/2a trial, which demonstrated that BIO89-100 has the potential to combine strong efficacy, a favorable safety and tolerability profile, and potentially best-in-class dosing convenience. We are encouraged by the robust responses that were observed across various efficacy measures and believe these improvements will translate into histology benefits in ENLIVEN.”
ENLIVEN is a multicenter, randomized, double-blind, placebo-controlled Phase 2b study in biopsy-confirmed NASH patients with fibrosis stage 2 or 3. A total of 216 patients will receive either one of two weekly doses (15mg or 30mg) or an every two-week dose (44mg) of BIO89-100 in a liquid formulation or placebo for 24 weeks. All patients will continue treatment in a blinded extension phase for 24 weeks for a total treatment period of 48 weeks, with some of the placebo patients re-randomized to receive BIO89-100 in the extension phase. The primary endpoints at Week 24 are NASH resolution without worsening of fibrosis and the improvement of fibrosis = 1 stage without worsening of NASH.
Concurrent with the initiation of ENLIVEN, 89bio has established a steering committee for the trial comprising a distinguished group of clinicians, researchers, and experts in NASH. Members of the steering committee include:
89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate, BIO89-100, is a specifically engineered glycoPEGylated analog of FGF21. BIO89-100 is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). 89bio is headquartered in San Francisco with operations in Herzliya, Israel.
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