89bio, Inc. announced the presentation of post-hoc exploratory analyses of additional data from the paired-biopsy, open-label expansion cohort (Cohort 7) in the Phase 1b/2a proof-of-concept study evaluating pegozafermin in patients with nonalcoholic steatohepatitis (NASH). These data were featured in a poster presentation (abstract #36901) at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting(R) 2022, being held virtually and in Washington, D.C., from November 4 -- 8, 2022. A copy of the poster presentation will be accessible under "Scientific Publications" in the pipeline section of 89bio's website. In this open-label cohort, NASH patients were treated once weekly for 20 weeks with 27 mg of pegozafermin. For the primary analysis, biopsies were read centrally at baseline and at end of treatment by a single expert liver pathologist (central reader). In a post-hoc exploratory analysis, a panel of three additional expert NASH pathologists (three-reader panel) assessed the same baseline and end of treatment slides that had been evaluated by the central reader. The
expected inter-reader variability common in NASH studies was observed. The three-reader panel scored six of the 19 patients as having F4 fibrosis at baseline (putative F4), which was an exclusion criterion for the Phase 1b/2a study. pegozafermin Pegozafermin is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21) being developed for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). FGF21 is an endogenous hormone that modulates important drivers of lipid metabolism and NASH including triglyceride reduction, glycemic control, steatosis, inflammation and fibrosis. Pegozafermin was specifically engineered using a unique glycoPEGylated technology to extend the half-life while maintaining potency. Pegozafermin is currently being evaluated in the Phase 2b ENLIVEN trial in NASH and is expected to move into Phase 3 program for SHTG in 2023. Recent Phase 2 data with pegozafermin in SHTG patients demonstrated significant and clinically meaningful reductions in triglycerides as well as improvements in other cardiometabolic measures. Additionally, Phase 1b/2a data with pegozafermin in biopsy-confirmed NASH patients demonstrated clinically meaningful changes on histology endpoints and non-invasive measures of total liver health as well as many of the underlying metabolic comorbidities commonly associated with NASH. About 89bio 89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of non-alcoholic
steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially
best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological
activity through an extended half-life. The company is headquartered in San Francisco with operations in Herzliya,
Israel.