Following a no letter from Canadian regulators, XORTX Therapeutics Inc. (NASDAQ: XRTX) shares increased 9.21% to $0.83 on Tuesday after-hours trading.
What letter has XRTX received?
Health Canada recently sent a second no objection letter (NOL) addressing the company’s ongoing XRX-OXY101 clinical bridging pharmacokinetics trial (the “Study”) to XORTX Therapeutics (XRTX). The study was initially intended to be a three-part study, and Health Canada got an NOL in April. Parts 1 and 2 of the Study have been successfully completed by XORTX. Part 3 has been updated, and Part 4 has been added.
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XRX-original OXY-101’s design had three goals: figuring out which of XORTX’s novel formulations produces the highest levels of oxypurinol in the bloodstream; figuring out how food affects this formulation’s bioavailability; and figuring out the safety and pharmacokinetics of multiple doses of this chosen formulation. Following the completion of parts 1 and 2, XRTX revised part 3 to add a new characterization of the impact of meals, and it added a fourth aim, part 4, to describe the amount of oxypurinol absorbed after three successively higher doses of XRx-008. In order to assist the Company’s upcoming phase 3 registration study in Autosomal Dominant Polycystic Kidney Disease (“ADPKD”), information gathered over the course of this trial will give recommendations about the oral dose of oxypurinol formulations in the future. Additionally, this study will offer information to assist upcoming NDA (New Drug Application) marketing filings to the European Medicines Agency and the US Food and Drug Administration (“FDA”).
How will the letter enable XRTX to move forward?
Health Canada granted XORTX Therapeutics (XRTX) the NOL for the revised pharmacokinetic study since the study has so far demonstrated that the unique, proprietary xanthine oxidase formulation XRx-008 has a significantly enhanced bioavailability. The Part 3 and 4 designs can move forward, according to this Health Canada NOL. The Study’s two components will be carried out concurrently. Notably, part 3’s successful screening has been finished, and dosing will soon start while part 4’s screening is in progress. Tablets comparable to those that will be used in its phase 3 registration trials will be used to medicate participants in Parts 3 and 4. The Study’s conclusion will assist the XRx-008 program through FDA 505(b)2 development, its next phase 3 registration study, and ultimately toward marketing approval for the treatment of those with progressive kidney disease caused by ADPKD.