• 8 April 2019
    Genkyotex to present updated Interim Results from Phase 2 Trial of GKT831 in Primary Biliary Cholongitis at 2019 EASL International Liver Congress (ILC)

    Genkyotex (Euronext Paris & Brussels: FR0011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced that it will present an update on the previously reported interim efficacy results from its Phase 2 trial of GKT831 in Primary Biliary Cholangitis (PBC) during the 2019 EASL International Liver Congress (ILC), being held in Vienna, from April 10-14.

    The abstract has been accepted for oral presentation during general session on April 11, from 2:15-2:30 pm. The presentation, entitled “Efficacy of GKT831 in patients with primary biliary cholangitis and inadequate response to ursodeoxycholic acid: Interim efficacy results of a phase 2 clinical trial”, was also selected, via a peer-review process, for inclusion in the “Best of ILC” summary slide deck. The results to be presented include the effect of GKT831 on markers of cholestasis and inflammation following just six weeks of treatment.

    Elias Papatheodorou, CEO of Genkyotex, commented: “We are pleased by the significant interest KOLs are showing in these data, supporting our differentiated novel therapeutic candidate, GKT831. Unlike other drugs that target primarily cholestasis, GKT831 targets the inflammatory and fibrotic components of PBC. While the antifibrotic activity of GKT831 will be assessed at week 24, GKT831 has already exhibited significant anti-cholestatic and anti-inflammatory activity after only 6 weeks of treatment. GKT831’s mechanism of action has the potential to modify the course of severe diseases in the liver, lungs and the kidneys.”

    The Phase 2 trial is a 24-week, double-blind, placebo-controlled study, evaluating the safety and efficacy of GKT831 in patients with PBC following inadequate response to ursodeoxycholic acid (UDCA). A total of 111 PBC patients were enrolled and allocated to three treatment arms: UDCA plus placebo, UDCA plus GKT831 400mg once a day, and UDCA plus GKT831 400mg twice a day. GKT831 has exhibited a particularly favorable safety profile throughout the 24-week treatment period. No drop outs or treatment interruptions due to pruritus or fatigue were reported. Only two serious adverse events were reported, a grade 1 urinary infection and multiple bone fractures related to a traffic accident. Both cases were deemed unrelated to study drug by the investigators. Final results of the trial at week 24 are expected in Spring 2019.