ETNB - 89bio gains 47% on topline data for NASH candidate

2023-03-22 07:44:35 ET

Liver disease drug developer 89bio ( NASDAQ: ETNB ) added ~47% on Wednesday after announcing topline data from its Phase 2b ENLIVEN trial for pegozafermin in patients with nonalcoholic steatohepatitis (NASH).

The trial involved 219 patients who were randomized to receive pegozafermin at 44mg every two weeks, 30mg weekly, 15mg weekly, or placebo.

Citing 24-week data, 89bio ( ETNB ) said that patients in the 44mg Q2W and 30mg QW groups reached both the primary histology endpoints with high statistical significance.

26% and 27% of those in the 30mg QW group and 44mg Q2W group were found to have at least one-stage fibrosis improvement without NASH worsening compared to 7% in the placebo group implying over 3.5 times the placebo rate.

The incidence of NASH resolution without worsening of fibrosis stood at 23% and 26% in 30mg QW groups and 44mg Q2W groups compared to 2% in the placebo group indicating 12 – 14 times improvement over the placebo rate.

Grade 1 or 2 gastrointestinal events (diarrhea, nausea, and increased appetite) were among the most commonly reported treatment-related adverse events, most of which were mild to moderate in severity.

However, five patients who received pegozafermin discontinued the trial due to treatment-related AEs, while there were no discontinuations in the placebo group.

89bio ( ETNB ) says that the data readout supports the advancement of pegozafermin to Phase 3 development.

Other developers of NASH therapies include Intercept Pharmaceuticals ( ICPT ), Madrigal Pharmaceuticals ( MDGL ), Arrowhead Pharmaceuticals ( ARWR ), Akero Therapeutics ( AKRO ), and NGM Biopharmaceuticals ( NGM ).

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