Genkyotex (Euronext Paris & Brussels: FR00011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies, announces today that 90 patients have been randomized in its Phase 2 trial of GKT831 for the treatment of Primary Biliary Cholangitis (PBC). This represents the target number of patients required to conduct the pre-planned interim analysis. The analysis will be conducted when these patients have completed 6 weeks of dosing.
“We are excited to reach this important milestone, which will enable us to conduct the interim analysis in the Fall of this year, as previously planned,” said Elias Papatheodorou, Chief Executive Officer of Genkyotex. “Enrollment was robust even during the Summer months, and we wish to thank our investigators and their teams for their outstanding contribution to this important clinical trial. Importantly, the safety profile of GKT831 remains favorable with no serious adverse events and no liver-related adverse events reported to date.”
This Phase 2 trial is a 24-week, double-blind, placebo-controlled study, evaluating the safety and efficacy of GKT831 in patients with PBC and inadequate response to ursodeoxycholic acid (UDCA). A total of approximately 102 PBC patients will be enrolled and allocated to three treatment arms: UDCA plus placebo, UDCA plus GKT831 at 400mg once a day, and UDCA plus GKT831 at 400mg twice a day.