Genkyotex (Euronext Paris & Brussels: FR00011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced that the independent Safety Monitoring Board (SMB) for its Phase 2 trial of GKT831 for the treatment of Primary Biliary Cholangitis (PBC) held its first pre-planned data review meeting and recommended the continuation of the Company’s trial without protocol amendment. In addition, and as previously indicated, no serious adverse events, liver-related adverse events or drop outs have been reported to date.
“The successful outcome of the first SMB meeting is consistent with the good clinical safety profile of GKT831 observed to date. We are pleased to be able to continue the trial without modification and look forward to the results of the interim efficacy analysis, which are expected this Fall,” said Elias Papatheodorou, CEO of Genkyotex.
The first pre-planned SMB meeting was initiated according to the SMB charter. The independent SMB members reviewed all available clinical, pharmacokinetics, and safety laboratory data, including data from patients who have completed the full 24-week treatment period. The SMB recommended the continuation of the study as per protocol, with no changes or additional data collection required.
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. A total of 102 PBC patients will be enrolled and allocated to placebo or one of two doses of GKT831 (400mg once a day or 400mg twice a day).