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89bio's lead drug shows positive effect in NASH study

Sep. 14, 2020 8:42 AM ET89bio, Inc. (ETNB) StockETNBBy: Douglas W. House, SA News Editor1 Comment
  • 89bio (NASDAQ:ETNB) announces positive results from a Phase 1b/2a clinical trial evaluating lead candidate BIO89-100 in patients with nonalcoholic steatohepatitis (NASH).
  • All dose groups experienced significant reductions in liver fat at week 13. Reductions of up to 60% versus baseline and relative reductions of up to 70% versus placebo, measured by MRI-PDFF, were observed. 88% of treated patients achieved at least a 30% reduction in liver fat from baseline while 71% achieved at least a 50% reduction.
  • Significant reductions in triglycerides (up to 28%), non-HDL cholesterol (up to 16%) and LDL-C ("bad" cholesterol) (up to 16%) were also noted.
  • On the safety front, the profile of BIO89-100 was comparable to control. The most frequent treatment-related adverse events were diarrhea (12.7%) (22.2% in the control arm) and nausea (7.9%) (16.7% in the control arm).
  • The next NASH study should launch in H1 2021.
  • BIO89-100 is a pegylated (long-acting) analog of a protein called fibroblast growth factor 21 (FGF21) that plays a key role in regulating certain metabolic pathways.
  • Nasdaq shows a 26% jump in premarket share price but no volume.
  • Wall Street is Bullish. 

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