XORTX Therapeutics IncXRTX has announced topline results from the XRX-OXY-101 – Bridging Pharmacokinetics Clinical Trial characterizing the pharmacokinetics of formulated oral oxypurinol, XORLO.
The study showed that XORLO was well tolerated across the various dosing regimens. No safety issues were identified in any of the four parts of the 88-subject study.
Results from the four parts of the study showed a substantial increase in the bioavailability of oxypurinol with the XORLO formulation platform, increased dose proportionality compared to non-formulated oxypurinol, and multiple dosing regimens that achieved therapeutic target values.
These results will provide key data to facilitate precise dosing recommendations for the upcoming Phase 3 registration trial in individuals with progressing kidney disease due to autosomal dominant polycystic kidney disease.
When taken with food, an average increase of exposure of ~40% was observed in oxypurinol compared to the fasted state.
Results demonstrated that increased bioavailability of 100% or more could be achieved with test formulations compared to non-formulated oxypurinol alone.
Price Action: XRTX shares are up 63.51% at $1.28 during the premarket session on the last check Thursday.
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