CALT - Calliditas/Genkyotex's setanaxib shows encouraging action in early-stage study

Calliditas Therapeutics' ([[CALT]] +6.4%) subsidiary Genkyotex has announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex's lead asset.The study in 46 healthy volunteers demonstrated that setanaxib is well tolerated at the doses tested, with no safety signal or dose-limiting toxicity being identified. The trial consisted of a single ascending dose part and a multiple ascending dose part with dosing up to 1600mg/day.Based on interactions with the FDA, the company intends to pursue a Phase 2/3 trial in patients with primary biliary cholangitis ((PBC)).Previously, doses of 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. Significant improvement in fatigue was also achieved. All doses tested in that trial were well-tolerated, with no safety signal compared to

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Calliditas/Genkyotex's setanaxib shows encouraging action in early-stage study