- XORTX Therapeutics Inc. (XRTX) has submitted a clinical trial application (CTA) with Health Canada for a bridging pharmacokinetics study, XRX-OXY-101
- XRX-OXY-101 has been designed to look at the effect of food on the bioavailability and the safety and pharmacokinetics of oxypurinol concentrations
- The trial is in support of the company’s planned phase 3 registration trial in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- ADPKD is a rare disease and is typically diagnosed based on the expansion of fluid-filled cysts in the kidneys
- XORTX Therapeutics Inc. (XRTX) is down 2.30 per cent and is trading at $1.70 per share as of 1:27 p.m. ET
XORTX Therapeutics (XRTX) has submitted an application with Health Canada for a bridging pharmacokinetics study, XRX-OXY-101.
XORTX is a pharmaceutical therapeutics company focused on developing innovative therapies to treat progressive kidney disease.
XRX-OXY-101 has been designed with three important objectives. First to determine which of XORTX’s formulations results in the best circulating oxypurinol concentrations which help mediate uric acid levels in the blood system.
The study will also look at the effect of food on the bioavailability and the safety and pharmacokinetics of multiple doses of the formulation.
Knowledge gained during the trial will provide guidance regarding the future oral dosing of oxypurinol formulations in support of the company’s planned phase 3 registration trial in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Additionally, this study will provide data to support future New Drug Application marketing submissions to the United States Food and Drug Administration and the European Medicines Agency.
ADPKD is a rare disease and is typically diagnosed based on the expansion of fluid-filled cysts in the kidneys. Over time, the increasing number and size of cysts can contribute to structural and functional changes to kidneys and is frequently accompanied by chronic pain which is a common problem for patients with ADPKD.
For individuals with progressing ADPKD, treatment recommendations include anti-hypertensive treatment and dietary restrictions and there is a need for new therapies to slow the decline of kidney function.
XORTX Therapeutics Inc. (XRTX) is down 2.30 per cent and is trading at $1.70 per share as of 1:27 p.m. ET.