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XORTX Submits FDA pre-IND Meeting Documents
● Advancing to a Phase II Clinical Study in Polycystic Kidney Disease ●
CALGARY, Alberta, Aug. 13, 2018 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (CSE:XRX; OTCQB:XRTXF), a biopharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce that the Company with its collaborative partner, Cato Clinical Research, has filed its pre-IND meeting documents with the FDA. These pre-IND meeting documents provide a comprehensive overview of the program and facilitate formal communications with the FDA regarding development of XRx-008 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) in advance of the Company’s meeting with the FDA that is scheduled for September 20th, 2018. Further announcements are anticipated regarding meeting outcome.
XORTX is focused on advancing XRx-008 through phase II clinical trials for the treatment of ADPKD. At the present time, despite considerable effort, very few approved therapeutic options exist to treat progressive kidney disease (PKD). There is reason for hope, however, as recent clinical study evidence confirms that uric acid is an independent risk factor for progression of PKD and that managing purine metabolism and serum uric acid concentrations can positively affect the kidney health thereby improving the lives of patients with PKD.
Dr. Allen Davidoff, XORTX’s CEO stated, “The filing of the pre-IND package documents facilitates the opening of communications with the FDA regarding XORTX’s program development plans. The Company looks forward to advancing this program through our first phase II clinical study in patients with ADPKD. Feedback from the FDA will support and guide XORTX efforts to optimize the critical path steps needed to gain marketing approval of this therapy for PKD patients.”
About XORTX Therapeutics Inc.
XORTX Therapeutics Inc. is a BioPharmaceutical company focused on developing innovative therapies to treat progressive kidney disease. XORTX has lead programs to develop treatments for progressive kidney disease due to diabetes, diabetic nephropathy and polycystic kidney disease. Secondary programs focus on developing therapies for health consequences that accompany pre-diabetes, diabetes and cardiovascular disease. Additional information on XORTX Therapeutics is available at www.XORTX.com.
The CSE has neither approved nor disapproved the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.