89bio announces long-term data from ENLIVEN Phase 2b trial of pegozafermin

89bio announced positive topline data from the blinded extension phase of its Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis. At week 48, both the 30mg weekly and 44mg every-two-week dosing schedules of pegozafermin demonstrated statistically significant improvements across key markers of liver health. The benefits observed at week 48 were consistent with the results observed at week 24, indicating sustained benefits over time. “We are very encouraged by these long-term efficacy and tolerability data which establish pegozafermin as the first FGF21 analog candidate to demonstrate positive, sustained benefits over a 48-week period in patients with advanced NASH,” said Hank Mansbach, Chief Medical Officer of 89bio. “Notably, we observed consistent and robust benefits in F2-F3 NASH patients, as well as in subgroups of patients receiving concurrent GLP-1 therapy and F4 patients with compensated cirrhosis, validating pegozafermin’s anti-fibrotic effects across a broad spectrum of patients. The sustained improvement in observed key liver health markers could lead to greater histological response rates, which we will aim to confirm in Phase 3 development. We are working with the regulatory agencies and look forward to providing additional details of our Phase 3 NASH program before the end of this year.”