XORTX Therapeutics Inc., a pharmaceutical therapeutics company that is focusing on the development of the innovative therapies for the purpose of treating the progressive kidney disease announced that, it has submitted a clinical trial application (CTA) along with the Health Canada for a study of XRX-OXY-101 bridging pharmacokinetics.
The XRX-OXY-101 Bridging Pharmacokinetics Study has been designed with the three very important objectives including to determine which of the novel formulations of XORTX has been resulting in the best circulating oxypurinol concentrations, along with the effect of the food on the bioavailability of the particular formulation and the safety and pharmacokinetic of the multiple doses of the selected formulation.
Additionally, the study is also going to be providing the data for supporting the future New Drug Application marketing submissions to the Food and Drug Administration (FDA) of the United States and also the European Medicines Agency.
Dr. Allen Davidoff said that, the company ‘XORTX’ has been pleased for having made this step of regulatory filing for the purpose of initiating the launch of the XRX-OXY101 bridging pharmacokinetic study.
He also said that, in a duration of several months, this study has been an very important first clinical step in the company’s clinical and regulatory plans for the year 2022 and it is also going to be supporting the XRx-008 program for the ADPKD and also the planned ohase 3 registration trial.
This clinical trial, that is initiated in Canada is going to be providing an important information for being used for the development of the XRx-008 through the market approval process of the US FDA.
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