Genkyotex (Euronext Paris & Brussels: FR00011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies, announces today that the independent Safety Monitoring Board (SMB) for its Phase 2 trial of GKT831 for the treatment of Primary Biliary Cholangitis (PBC) held its second pre-planned data review meeting and recommended the continuation of the Company’s trial without protocol amendment. This second review was based on data collected from 77 randomized patients including at least 60 patients who have completed their week 6 visit. The Company expects interim efficacy results in Fall 2018 and final results in the first half of 2019.
“The positive outcome of this second independent SMB meeting further supports the positive clinical safety profile of GKT831,” said Elias Papatheodorou, Chief Executive Officer of Genkyotex. “The SMB members reviewed all available clinical, pharmacokinetics, and safety laboratory data, from 77 randomized patients including 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 (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. To date, more than 90 patients have been enrolled.
Genkyotex also intends to initiate an open-label extension study for patients completing the ongoing Phase 2 trial, as the positive safety profile observed to date supports continued treatment with GKT831 beyond the planned 24 weeks. Based on its overall profile, the Company believes that GKT831 has therapeutic potential in a broad range of chronic diseases, including fragile patient populations. In this context, the company recently announced that the United States National Institutes of Health (U.S. NIH) awarded an $8.9 million grant to Genkyotex’s academic collaborators to conduct a clinical trial of GKT831 in patients with idiopathic pulmonary fibrosis (IPF), an aggressive lung disease that results in progressive fibrosis of the lungs.