XORTX Therapeutics Inc. announced that a type B pre-Phase 3 meeting request with the FDA was submitted on July 6, 2022. The meeting is expected to be held in approximately 70 days from July 07, 2022. To date, the Company has successfully completed the research and development activities leading to this request and is advancing its XRx-008 program for the treatment of autosomal dominant polycystic kidney disease (ADPKD).

R&D activities during the past year leading to this meeting request included manufacturing clinical quality GMP oxypurinol, finalizing formulation of drug product, and characterizing improved oral bio-availability of oxypurinol in animal models. The company have achieved successful regulatory filings with the FDA and Health Canada and have commenced OXY-XRX-101 bridging pharmacokinetics study. These important milestones have positioned XORTX for the next important step – a pre-Phase 3 meeting with the FDA.