XORTX Therapeutics Inc., a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce that it has submitted a Type D meeting request to the US Food and Drug Administration (“FDA”) and has received a response setting the date for a virtual meeting on May 1, 2023. This is an exciting step forward in the journey to discover potential treatments for this debilitating condition.
XORTX’s XRx-008 program has the potential to achieve accelerated FDA marketing approval with the submission of their revised clinical trial protocol, XRX-OXY-301. This protocol is based on the XRX-OXY-101 bridging pharmacokinetic clinical trial and outlines plans for XORLOTM, XORTX’s proprietary oxypurinol formulation, for the treatment of autosomal dominant polycystic kidney disease (“ADPKD”). With the FDA’s permission for accelerated approval for specified validated endpoints such as total kidney volume in ADPKD, XORTX can now look forward to an earlier completion of their planned registration trial and more rapid marketing approval.
Dr. Allen Davidoff, CEO of XORTX, expressed his enthusiasm for the potential advancement of XORLOTM to the FDA for accelerated approval in treating individuals with a diagnosis of ADPKD. He is eager to explore FDA guidance for this approval through the XRX-OXY-301 clinical trial and to determine the best data needed for successful marketing approval.
XRX-OXY-301 is an exciting study that will examine the potential of XORLOTM, a xanthine oxidase inhibitor, to positively impact the rate of expansion of total kidney volume. By gaining an understanding of this effect, we can gain insight into ways to better manage kidney health.
The XRX-OXY-301 clinical trial is an exciting opportunity to evaluate the potential of a novel oxypurinol formulation to slow the progression of Stage 2-4 ADPKD in patients with coexisting hyperuricemia. Scheduled to begin in the second half of 2023, this Phase 3, Multi-Centre, Double-Blind, Placebo Controlled, Randomized Withdrawal Design Study will provide data to support a future Accelerated Approval NDA submission to the FDA and EMA. If successful, this could be a major breakthrough in treating this chronic and debilitating condition.
About XORTX Therapeutics Inc.
At XORTX, we are on a mission to develop medications that will improve the quality of life and future health of patients. We are currently working on two clinically advanced products: XRx-008, a program for ADPKD, and XRx-101, a program for acute kidney and other acute organ injuries related to Coronavirus / COVID-19 infection. Additionally, our pre-clinical stage program, XRx-225, aims to target Type 2 Diabetic Nephropathy. All of our programs focus on aberrant purine metabolism and xanthine oxidase to reduce or inhibit the production of uric acid. We are committed to providing effective treatments and hope to make a meaningful impact in the lives of those who need it most.