89bio presents data from ENLIVEN Phase 2b trial of pegozafermin in NASH

89bio announced that data from the Phase 2b ENLIVEN trial evaluating treatment with pegozafermin in patients with nonalcoholic steatohepatitis were published online in the New England Journal of Medicine. The data were simultaneously presented in a late-breaking oral session at the European Association for the Study of the Liver Congress 2023 in Vienna, Austria and were also selected for inclusion in the Best of EASL Congress summary. The randomized, double-blind, placebo-controlled 24-week Phase 2b ENLIVEN trial evaluated 219 adult patients of whom 192 had biopsy-confirmed fibrosis stages F2-F3 NASH and NAS greater than or equal to 4 for 24 weeks. In this trial, treatment with 44mg every-two-week and 30mg dosing groups resulted in statistically significant changes on both primary histology endpoints demonstrating at least one-stage fibrosis improvement without worsening of NASH at 3.5 times the placebo rate and NASH resolution without worsening of fibrosis, between 12 to 14 times the placebo rate. Treatment with pegozafermin also led to clinically meaningful changes compared to baseline in liver fat and other key non-invasive tests of liver inflammation and fibrosis. Improvements were observed in HbA1c, adiponectin and across lipid markers that are important factors for an effective treatment for NASH. In addition, reductions in liver and spleen volume were observed. The trial included 14 biopsy confirmed NASH patients with compensated cirrhosis who were not part of the primary analysis, but continued in the study, 12 of which underwent a follow-up biopsy at Week 24. Five out of eleven of these patients treated with pegozafermin had fibrosis improvement greater than or equal to1 stage without worsening of NASH.