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XORTX Announces Initiation of Clinical and Commercial Manufacturing of XORLO™

  • XORTX Therapeutics Inc. has initiated GMP drug substance & commercial-scale tablet manufacturing for its XRx-026 program to support the XRX-OXY-102 clinical study.
  • Production of the proprietary oxypurinol formulation XORLO™ is underway to provide clinical supply representative of material intended for future US FDA marketing approval.
  • Contract manufacturing of pure oxypurinol drug substance using the Company's proprietary synthetic pathway has begun.
  • XORTX is collaborating with its contract manufacturing partner to produce commercial drug batches, with validation & stability data expected to support an upcoming NDA filing.
  • The planned two-part XRX-OXY-102 clinical trial is being advanced based on prior positive results & discussions with the FDA.
  • XORLO™ aims to address unmet needs in gout treatment by offering an alternative to current xanthine oxidase inhibitors like allopurinol & febuxostat, which have limitations regarding tolerance & cardiovascular risk.
  • The Company's broader pipeline includes programs for ADPKD (XRx-008), acute kidney injury (XRx-101), Type 2 diabetic nephropathy (XRx-225), & kidney disease (VB4-P5).
  • Forward-looking statements regarding manufacturing timelines, trial conduct, & regulatory approval are subject to risks including capital needs, third-party manufacturing delays, & regulatory uncertainties.