Genkyotex announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib in healthy subjects. The study showed that setanaxib was well tolerated at doses up to 1,600 mg/day, and displayed generally dose-proportional exposure. No safety signal and no dose limiting toxicity were identified across the doses tested, in a total of 46 healthy adult male and female subjects. These results support the evaluation of substantially high doses, up to 1,600 mg/day, and provide an opportunity to pursue a pivotal clinical trial in patients with primary biliary cholangitis (PBC). Previously, doses up to 800 mg/day were evaluated in a 24-week Phase 2 trial in PBC patients. In that trial, 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. Significant improvement in fatigue was also achieved. At the same time, all doses tested were safe and very well tolerated with no safety signal compared to placebo. As a reminder, following a friendly takeover bid initiated by Calliditas Therapeutics AB (publ) on Genkyotex, the results of which were announced on December 17, 2020, Calliditas Therapeutics AB now holds 86.24% of the share capital and theoretical voting rights of Genkyotex.