XRTX - XORTX Therapeutics files application in Canada for pharmacokinetics study

XORTX Therapeutics (NASDAQ:XRTX) said it submitted a clinical trial application to Health Canada for a XRX-OXY-101 bridging pharmacokinetics study to support a future clinical program in Autosomal Dominant Polycystic Kidney Disease (ADPKD). "While only several months in duration, this XRX-OXY-101 study is an important first clinical step in our 505(b)2 clinical and regulatory plan for 2022 and will support the XRx-008 program for ADPKD as well as the planned phase 3 registration trial," said CEO Allen Davidoff. The company said the bridging pharmacokinetics study will help provide guidance on the future oral dosing of oxypurinol formulations for the phase 3 trial. Oxypurinol is used to prevent or lower high uric acid levels in the blood. The data will also support future marketing submissions to the U.S. FDA and the European Medicines Agency. XORTX (XRTX) has two products in development: XRx-008 for ADPKD; and XRx-101 for acute kidney and other acute organ

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XORTX Therapeutics files application in Canada for pharmacokinetics study