Policy & Regulation
Genkyotex SA's Phase 1 study in oral setanaxib demonstrated tolerance at the doses of up to 1600mg/day for treating PBC
18 January 2021 -

Genkyotex SA revealed on Friday that its Phase 1 study in oral setanaxib demonstrated tolerance at the doses of up to 1600mg/day, with no safety signal or dose-limiting toxicity being identified, in 46 healthy adult male and female subjects.

According to the company, the encouraging results provide an opportunity to pursue a pivotal Phase 2/3 clinical trial in patients, with primary biliary cholangitis (PBC), based on interactions with the US FDA. PBC is an autoimmune disease of the liver.

Under the study, the company assessed the safety and pharmacokinetics of oral setanaxib at selected doses in 46 healthy adult male and female subjects. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part of up to 1600mg/day.

In the company's prior a 24-week Phase 2 trial in PBC patients, setanaxib dosed at 800 mg/day achieved reductions in markers of cholestasis, including alkaline phosphatase and in multiple non-invasive markers of liver fibrogenesis, including liver stiffness and PRO-C3 and C3M. All doses tested in that trial were well-tolerated, with no safety signal compared to placebo.

Genkyotex SA is a subsidiary of Calliditas Therapeutics AB (publ) (Nasdaq OMX:CALTX) (NASDAQ:CALT), a specialty pharmaceutical company based in Stockholm, Sweden.

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