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

September 14, 2020

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 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.

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