Benzinga | Aug 2, 2021 08:34AM EDT

89bio Says Completed Target Enrollment In Histology Cohort To Evaluate BIO89-100 For Treatment Of NASH

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 that it has completed target enrollment of 20 patients in the paired-biopsy, open-label histology cohort in biopsy-confirmed fibrosis stage F2 -- F3 NASH patients.



"This is an important clinical milestone and step forward in advancing BIO89-100 as a new treatment option for patients suffering from NASH," said Hank Mansbach, Chief Medical Officer of 89bio. "We believe assessing histology endpoints could reinforce the robust efficacy improvements we previously observed in our proof-of-concept study and will provide further validation of the FGF21 class. In addition, this cohort is intended to support both the clinical utility of BIO89-100 and our overall clinical development strategy in NASH. We look forward to sharing topline data by year-end 2021."

The paired-biopsy, open-label histology cohort is an expansion of the Phase 1b/2a trial of BIO89-100 in NASH. In this cohort, biopsy-confirmed NASH patients are treated for 20 weeks with 27 mg of BIO89-100 once weekly. The key efficacy endpoints include a 2-point or greater improvement in the NAFLD Activity Score (NAS), NASH resolution without worsening of fibrosis, and the improvement of fibrosis ? 1 stage without worsening of NASH.