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  • 30 June 2020
    Genkyotex announces the dosing of the first subjects in its Phase 1 study with high-dose setanaxib

    Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced the initiation of a Phase 1 clinical study with high-dose setanaxib in healthy subjects.

    This new Phase 1 study aims to support the inclusion of doses of up to 1,600 mg/day in future clinical trials, including the pivotal trial which will support the registration of setanaxib in primary biliary cholangitis (PBC). The study was approved by the French Medicines Agency (ANSM) in May 2020.

    To date, five Phase 1 and three Phase 2 clinical studies have been conducted with setanaxib and no safety signal and no dose limiting toxicity have been observed. In the successfully completed PBC Phase 2 trial, 800 mg/day achieved consistently greater efficacy than 400 mg/day across multiple endpoints including improvements in markers of liver fibrosis, including a rapid reduction in liver stiffness and markers of collagen turnover. Superior efficacy was also achieved for fatigue, the main symptom reported by PBC patients, as well as for the cholestatic markers alkaline phosphatase (ALP) and gamma glutamyl transpeptidase (GGT).

    Genkyotex recently provided additional clinical data from the PBC Phase 2 trial highlighting setanaxib’s anti-fibrotic mechanism. Specifically, setanaxib improved markers of collagen turnover indicating reduced collagen synthesis and enhanced collagen degradation in patients with advanced liver fibrosis. These results provide further mechanistic insights for setanaxib’s anti-fibrotic activity and provide an explanation for the rapid reduction in liver stiffness already reported in these high-risk patients. Considering setanaxib’s excellent clinical safety profile, the company has decided to explore higher doses and anticipates superior efficacy based on the dose dependent effects observed in the Phase 2 PBC trial.

    The single ascending dose (SAD) part of the Phase 1 study will provide pharmacokinetics information for doses up to 1,600 mg. Subsequently, the multiple ascending dose (MAD) part of the study will evaluate setanaxib doses of 1,200 and 1,600 mg/day over a 10-day dosing period. A total of up to 54 male and female healthy subjects will be included in the study.

    Upon successful completion of this new Phase 1 study, Genkyotex plans to include higher doses in upcoming studies.

    “We are excited to initiate this study in a timely fashion despite the COVID-19 pandemics. This study is an important component of our development plans for setanaxib in multiple fibrotic indications. In particular, assessing these higher doses can support our registration strategy for setanaxib in PBC. We plan to provide further information about our pivotal program soon”, said Philippe Wiesel, M.D., Executive Vice President and Chief Medical Officer of Genkyotex.