• 16 January 2020
    Genkyotex Provides Business Update and Reports Gross Cash Position at December 31, 2019

    Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and the leader in NOX therapies, announced today gross cash and cash equivalents of €2.4 million as of December 31, 2019. The existing gross cash and cash equivalents provide cash runway to end of Q1 2020.

    Clinical highlights

    During the fourth quarter of 2019, Genkyotex reported progress in clinical development of setanaxib:

    • The Company is in discussions with regulators to finalize the design of its phase 3 trial in primary biliary cholangitis (PBC) and plans to enroll patients with inadequate response to standard of care therapies, including the emerging population of patients receiving generically available PPAR agonists (e.g. bezafibrate). This is in contrast with other phase 3 programs which exclude these patients. The phase 3 will include measurements of liver stiffness and quality of life which remains an unaddressed medical need. An agreement on the phase 3 design with the US Food and Drug Administration (FDA) is expected in the first half of 2020.

    • The FDA and the relevant Institutional Review Board (IRB) have approved the protocol of the Phase 2 IPF trial, allowing the initiation of patient enrollment. The first site initiation is anticipated shortly, with patient enrollment expected to start in February. The trial size, design, and endpoints are adequate to support the initiation of a phase 3 program in case of positive outcomes.

    This trial is fully funded by an $8.9 million grant awarded by the U.S. National Institutes of Health (NIH). The study is being led by Professor Victor Thannickal at the University of Alabama at Birmingham and includes a consortium of five investigational centers of excellence in the United States. The study will evaluate the safety and efficacy of setanaxib in 60 IPF patients receiving standard of care therapy (pirfenidone or nintedanib). Enrolled patients will be treated with setanaxib or matching placebo for 24 weeks. Efficacy endpoints include changes in plasma o,o’- dityrosine, a biomarker based on the mechanism of action of setanaxib, as well as standard clinical outcomes which include the 6-minute walk distance and forced vital capacity (FVC). The safety and tolerability of setanaxib will be also evaluated.

    • The principal investigators leading the diabetic kidney disease (DKD) trial decided, with agreement from Genkyotex, to expand the investigational network by adding centers in Germany, Denmark and New Zealand. Ethical committees have approved the study protocol in New Zealand and three sites are pending activation. Germany and Denmark will follow.

    • Following the positive efficacy and safety results of the Company’s Phase 2 trial of setanaxib in primary biliary cholangitis (PBC), the DKD trial protocol was amended to increase the dose to 400 mg BID. As of today, 13 patients have already completed the full 48-week treatment and no safety concerns have been reported.

    Research highlights

    Genkyotex continues to explore the therapeutic value of NOX inhibition in additional therapeutic areas, including oncology. The Company expects to secure non-dilutive grant financing to support its ongoing collaborations with academic partners.

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