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  • 29 October 2018
    Genkyotex Announces Positive Outcome from the Independent SMBís Third Pre-Planned Review of the Phase 2 Trial of GKT831 in Primary Biliary Cholangitis

    Genkyotex (Euronext Paris & Brussels: FR00011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies (the “Company”), 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 third pre-planned data review meeting and recommended the continuation of the Company’s trial without protocol amendment. 

    “This third positive SMB review meeting further supports GKT831’s favorable safety profile in patients with PBC,” said Philippe Wiesel, Chief Medical Officer of Genkyotex. “The SMB assessed safety data collected in 110 patients allocated to GKT831 400mg once a day, GKT831mg twice a day, or placebo. There were 87 patients reviewed who had completed their week 6 visit. Furthermore, 69 subjects had reached week 12 and of these 41 had reached as far as week 24. We now look forward to interim efficacy data from this study, which will be available in early November.”

    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 111 PBC patients were enrolled and allocated to three treatment arms: UDCA plus placebo or UDCA plus one of the two doses of GKT831 (400mg once a day or 400mg twice a day).

    Genkyotex continues the preparation of 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.