• 23 July 2020
    Genkyotex Provides Business Update and Reports Cash Position at June 30, 2020

    Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today reported cash and cash equivalents of €5.1 million as of June 30, 2020. This amount includes the French research tax credit of €0.9 million which was received by the Company in April 2020. The existing cash and cash equivalents provide cash runway to the end of February 2021. 

    Clinical highlights

    • End-of-phase-2 discussions with regulators for setanaxib in PBC: Genkyotex is currently discussing the registration strategy for setanaxib in PBC with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The End Of Phase 2 (EOP2) meeting with the FDA was not delayed by the COVID-19 situation and took place at the end of April 2020, as planned. Genkyotex requested and obtained, at the end of June 2020, scientific advice from the EMA’s Scientific Advice Working Party (SAWP) that provides a path for the late stage development and registration of setanaxib in PBC. Initial feedback was also received from the FDA following the End Of Phase 2 meeting held in April. Genkyotex will communicate on its late stage development plan once final approval of a common registration strategy has been obtained from the FDA and the EMA.

    • IPF phase 2 trial: the launch of the study, already approved by the FDA and the relevant Institutional Review Board (IRB), is still expected in 2020 despite the COVID-19 situation. This investigator-initiated 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) during a 24-week treatment. 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 that include the 6-minute walk test and forced vital capacity (FVC). Plasma levels of collagen fragments and the safety and tolerability of setanaxib will also be evaluated. The trial size, design, and endpoints are adequate to support the initiation of a Phase 3 program should there be a positive outcome.

    • DKD phase 2 trial: 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. To date, 28 patients have already completed the full 48-week treatment and no safety signals have been identified. The DKD investigator-initiated trial is being conducted primarily in Australia, with work ongoing to activate centers in New Zealand, Denmark and Germany.

    • Phase 1 study with setanaxib at high doses: the Company received, in May 2020, approval from the French Medicines Agency (ANSM) to initiate a Phase 1 clinical study in up to 54 healthy subjects to investigate the pharmacokinetics, potential for drug interactions and safety profile of setanaxib at doses up to 1,600mg. The first subjects were dosed at the end of June and the enrollment process is ongoing.

    Financial highlights

    On June 30, 2020, Genkyotex's cash and cash equivalents totaled €5.1 million vs. €5.6 million on March 31, 2020. This amount includes the French research tax credit of €0.9 million which was received by the Company in April 2020. Despite the COVID-19 situation, the Company still expects its current resources to support anticipated operations until the end of February 2021, taking into account the facts and assumptions detailed in note 2.1 “Going concern” of the December 31, 2019 consolidated financial statements. The Company will continue to inform the market of the possible impacts of COVID-19 on its operations.