The company said data from the study, dubbed XRX-OXY-101, showed that Xorlo was well tolerated across various dosing regimens.
No safety issues were seen in any of the four parts of the study on the 88 people who received drug.
The company added that results from the four parts showed (i) a substantial increase in the bioavailability of oxypurinol with the Xorlo formulation platform; (ii) increased dose proportionality compared to non-formulated oxypurinol; (iii) a multiple dosing regimen which achieved therapeutic target values; and (iv) confirmation of the innovations claimed in the recently granted U.S. and EU patents regarding the company’s proprietary formulations of oxypurinol.
The results will provide data to facilitate dosing recommendations for an upcoming phase 3 trial in patients with progressing autosomal dominant polycystic kidney disease (ADPKD), according to the company.
ADPKD is an inherited disorder in which small fluid-filled sacs called cysts develop in the kidneys.
“The comprehensive characterization of this drug and its unique proprietary formulation provides a substantial understanding of how the XORLOTM formulation behaves pharmacokinetically in individuals,” said Xortx CEO Allen Davidoff.
XRTX +63.52% to $1.28 premarket Jan. 19
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