XORTX: Pharmacokinetics Bridging Study Part 2 Shows Increased Oral Bioavailability
XORTX Therapeutics Inc. (XRTX), a late stage clinical pharmaceutical company focused on therapies to treat progressive kidney disease, announced Monday positive topline results from its Part 2 Pharmacokinetics Bridging Study.
The Pharmacokinetics Bridging Study – XRX-OXY-101 – Part 2 showed a substantial increase in oral bioavailability of XORTX’s proprietary oxypurinol formulation provided with food compared to the fasted state.
Along with the improved bioavailability findings in Part 2, the study showed a clean safety and pharmacologic profile with no drug related adverse or serious adverse events related to oral administration of oxypurinol.
The company noted that Part 2 of the Study required successful recruitment, administration of a single oral dose of drug formulation in individuals who were fasted or fed a meal.
Subsequently, blood sampling and bioanalytical evaluation were conducted in Part 2 of the Study to characterize the pharmacokinetics and bioavailability of a unique proprietary formulation of oxypurinol administered in advance of the Company’s planned Phase 3 registration clinical trial in autosomal dominant polycystic kidney disease or ADPKD.
The company expects knowledge gained during the conduct of this clinical trial will provide guidance regarding the formulation selected and the oral dosing regimen necessary to reach and maintain the target circulating concentration of oxypurinol to be used in the planned Phase 3 registration trial.
The initiation of patient dosing is scheduled for the first half 2023.
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