XORTX Announces Pre-Phase 3 Meeting Date with US Food and Drug Administration.
ENPNewswire-August 5, 2022--XORTX Announces Pre-Phase 3 Meeting Date with US Food and Drug Administration
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Release date- 04082022 - CALGARY, Alberta - XORTX Therapeutics Inc. ('XORTX' or the 'Company') (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce that the pre-Phase 3 meeting request made to the US Food and Drug Administration ('FDA') has resulted in the grant of a virtual meeting scheduled on September 16, 2022. In advance of this meeting, XORTX has submitted a 'Pre-Phase-3 Briefing Package' to the FDA on Thursday, July 28, 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 has achieved successful regulatory filings with the FDA and Health Canada and has commenced its OXY-XRX-101 bridging pharmacokinetics study. These important milestones have well positioned XORTX for this pre-Phase 3 meeting with the FDA.
The Pre-Phase 3 Briefing Package provides an up-to-date summary of the extensive work completed for the XRx-008 program and this type B meeting. In addition, the briefing package presents an agenda including topics and questions for discussion related to the critical developmental steps necessary to complete the planned clinical registration trial and for the marketing approval application.
Dr. Allen Davidoff stated, 'We are pleased to advance the XRx-008 program with this filing and establish a meeting date with the FDA. We believe the discussions with the FDA will clarify the optimal, key clinical steps needed in advance of filing a US marketing application new drug approval (NDA) toward discussions with the FDA and to advance the XRx-008 program.'
About Type B Meetings
Type B meetings are routine meetings that occur at pre-defined endpoints between the FDA and a sponsor. Meetings typically occur right after or right before the submission of clinical data or a new drug filing. Type B meetings can be for the...
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