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  • 13 May 2020
    Genkyotex receives approval from the French Medicines Agency (ANSM) to initiate a Phase 1 clinical study with high-dose setanaxib

    Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced the approval from the French Medicines Agency (ANSM) to initiate a Phase 1 clinical study to investigate setanaxib at doses up to 1600 mg/day. Study initiation is anticipated in Q2 2020 with full results expected by the end of Q3 2020. 

    The evaluation of doses up to 1600 mg/day will support higher doses for future setanaxib trials, including in idiopathic pulmonary fibrosis (IPF) and primary biliary cholangitis (PBC). Genkyotex is currently discussing the registration strategy for setanaxib in PBC with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). The end of Phase 2 (EOP2) meeting with the FDA was not delayed due to COVID-19 situation and took place, at the end of April 2020, as planned.

    This new Phase 1 study will investigate the safety, pharmacokinetics of setanaxib, as well as its potential for drug-drug interactions, at doses up to 1600 mg/day in up to 54 healthy adult male and female subjects. Taking into account the impact of the current COVID-19 pandemics, Genkyotex anticipates the initiation of the study in Q2 2020 with full results of both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) by the end of Q3 2020.

    The ANSM approval highlights setanaxib’s favorable toxicology and clinical safety profile. To date, over 275 human subjects have been exposed to setanaxib in five Phase 1 and three Phase 2 clinical studies, and no safety signal and no dose limiting toxicity have been observed. The recent successful Phase 2 trial with setanaxib in PBC showed that the compound was safe and well-tolerated at all doses tested, including 400 and 800 mg/day. This Phase 2 trial demonstrated dose-dependent effects on markers of liver inflammation and fibrosis, and on quality of life measures including fatigue.

    Furthermore, Genkyotex has also successfully completed a Phase 1 clinical study in healthy subjects to support the transition from the previous capsule formulation to the new high dose 400 mg tablet formulation.

    “Regulatory approval to evaluate setanaxib at doses up to 1600 mg/day attests to the excellent safety profile of our lead compound. Successful results of this Phase 1 study will allow us to include higher doses in future setanaxib trials and reach the full efficacy potential of setanaxib. In addition, we are progressing with our regulatory agency discussions and will communicate the final outcome in the near future”, said Philippe Wiesel, M.D., Executive Vice President and Chief Medical Officer of Genkyotex.