89bio launches new trial for the treatment of non-alcoholic steatohepatitis

By Chris Wack

89bio Inc. has declared that it has started a Phase 2b trial evaluating BIO89-100 for the treatment of patients with stage 2 or 3 fibrosis of non-alcoholic steatohepatitis.

The biopharmaceutical company said the trial builds on positive data from a Phase 1b / 2a trial which demonstrated that BIO89-100 has the potential to combine high efficacy, a favorable safety profile and tolerability. and potentially best-in-class dosing convenience.

The trial will be a multicenter, randomized, double-blind, placebo-controlled phase 2b study in biopsy-confirmed NASH patients with stage 2 or 3 fibrosis. A total of 216 patients will receive one of two weekly doses or one dose every other weekly dose of BIO89-100 in liquid formulation or placebo for 24 weeks. All patients will continue treatment in a blinded extension phase for 24 weeks for a total treatment period of 48 weeks, with some of the placebo patients re-randomized to receive BIO89-100 in the extension phase.

The primary endpoints at week 24 are resolution of NASH without worsening fibrosis and improvement in fibrosis stage without worsening NASH.

89bio shares were up 4%, to $ 20.50, in pre-market.

Write to Chris Wack at [email protected]

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