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FDA Confirms Eligibility of XORLO™ for Accelerated Approval

Friday, May 05, 2023

XORTX Therapeutics Inc., a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce completion of a positive and constructive Type D meeting with the U.S. Food and Drug Administration (“FDA”) which resulted in the identification of additional clinical endpoints potentially available for accelerated approval and further understanding of the FDA expectations for the accelerated approval of XORLO™ for the treatment of autosomal dominant polycystic kidney disease (“ADPKD”).

The FDA Type D meeting was conducted to discuss with the agency the details of the accelerated approval process, a clinical trial protocol for the XRX-OXY-301 study, and proposed future clinical development program plans for XORLO™, XORTX’s proprietary oxypurinol formulation, for the treatment of ADPKD. The overall outcomes of the meeting included:

1/ Increased clarity regarding accelerated approval endpoints that would qualify for a new drug application (“NDA”), leading to marketing approval of XORLO™ for ADPKD.

2/ Phase 3 clinical trial parameters such as duration of treatment period required, follow up periods for subjects recruited into the trial and preferred statistical analysis methods, including the optimal information needed by the FDA in their decision-making process.

3/ With this information in hand, XORTX will now choose its primary clinical endpoint(s) and development strategy based on ongoing discussions with prospective partners for the asset.

4/ XORTX also intends to initiate and pursue a Special Protocol Assessment (SPA) with the FDA for the XRX-OXY-301 program to further de-risk the development program for XORLO™ for the treatment of ADPKD.

Dr. Allen Davidoff, CEO of XORTX, stated, “As a result of this Type D meeting with the FDA, the Company is in a much better position to advance and communicate the path to accelerated approval. We now have the optimal information needed to conduct the XRX-OXY-301 phase 3 clinical trial of XORLO™ to treat individuals diagnosed with ADPKD. The combination of Orphan Drug Designation granted April 21st and information from this Type D meeting signifies key data for the phase 3 registration trial and for ongoing partnering discussions.”



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