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SAFETY AND EXCHANGES COMMISSION
Washington, D.C. 20549
FOREIGN PRIVATE ISSUER REPORT PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of August 2022
Board file number: 001-40858
XORTX Therapeutics Inc.
745 Thurlow Street, Suite 2400, Vancouver, British Columbia, Canada, V6E 0C5
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|XORTX Therapeutics Inc.|
|Date: August 22, 2022||By:||/s/ Allen Davidoff|
|Last name:||Allen Davidoff|
|Title:||Chief executive officer|
INDEX OF EXHIBITIONS
XORTX Announces Top Positive Results from Part 2 Pharmacokinetic Transition Study
Clinical trial shows significantly increased bioavailability with food and clean safety and pharmacological profile
CALGARY, Alberta, Aug. 22, 2022 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on the development of innovative therapies to treat progressive renal failure, is pleased to announce the first positive results of its pharmacokinetic transition study – XRX-OXY-101 – Part 2 – (“Part 2”) showing a substantial increase in the oral bioavailability of XORTX’s proprietary oxypurinol formulation in the fed versus fasted state. Additionally, the improved Part 2 bioavailability results accompanied a safety and pharmacological profile with no drug-related or serious adverse effects related to oral administration of oxypurinol.
Part 2 of this study required successful recruitment, administration of a single oral dose of drug formulation to fasted or fed individuals. Subsequently, blood sampling and bioanalytical evaluation were performed in Part 2 of this study to characterize the pharmacokinetics and bioavailability of a proprietary proprietary formulation of oxypurinol administered prior to the planned Phase 3 registrational clinical trial. by the company in autosomal dominant polycystic kidney disease (“ADPKD”).
Pharmacokinetic transition study XRX-OXY-101 – XRX-OXY-101 is designed with four important objectives: 1) To determine which of the new formulations of XORTX results in the greatest circulating oxypurinol concentrations and oxypurinol exposure; 2) determine the effect of food on the bioavailability of the selected formulation; 3) determine the effect of an increasing dose range on the bioavailability of the selected formulation; and 4) to determine the safety and pharmacokinetics of multiple doses of the selected formulation. The knowledge gained during the conduct of this clinical trial will provide guidance regarding the selected formulation and oral dosing regimen needed to achieve and maintain the target circulating concentration of oxypurinol for use in the planned Phase 3 registration trial, with patient dosing initiation scheduled for the first half of 2023.
Part 2 of the XRX-OXY-101 study achieved the following objectives:
1) Confirmed an increase in bioavailability of the XORTX formulation when co-administered with food;
2) Addition of additional key data to the XORTX pharmacokinetic dataset characterizing the oral bioavailability of the proprietary formulation; and
3) Built on the pharmacokinetic and safety data base of oxypurinol safety and XORTX proprietary formulation
Dr. Allen Davidoff, CEO of XORTX, said, “The successful completion of Part 1 and now Part 2 of the XRX-OXY-101 study provides key data and insights to select clinical dose and formulation for future oral dosing for our planned phase 3. registration test in ADPKD. The results from this study support the XRx-008 program, understanding the absorption, distribution, metabolism and excretion (ADME) of oxypurinol in our formulation. These four key ADME criteria influence drug levels, drug exposure kinetics, drug performance and pharmacological activity. Pharmacokinetic modeling of these two datasets will provide key information regarding the safe and effective administration of oxypurinol and guide decision-making as we plan and execute the clinical and commercial development of the XRx-008 program. We look forward to the launch of the XRX-OXY-101 Part 3 assay in the near future. »
About XRX-OXY-101 – a Bridging Pharmacokinetics Study. Part 1 of the study involved dosing under fasting conditions. Part 2 measured the effect of food on pharmacokinetics and Part 3 of the XRX-OXY-101 clinical trial is a multiple-dose pharmacokinetic evaluation that will be undertaken in the second half of 2022. The evaluation of safety is also an important aspect of the XRX-OXY -101 clinical trial. The study is designed to allow XORTX to characterize the relative safety and bioavailability of XRx-008 program formulations. The knowledge gained during the conduct of this trial now provides essential oral dosing guidance for our planned registration trial in ADPKD.
Previously, Part 1 of the XRX-OXY-101 study had the following objectives:
1) Confirmation of improved human bioavailability of XORTX formulations of oxypurinol for future development;
2) Established a pharmacokinetic dataset characterizing the oral bioavailability of XORTX formulations for future population-based pharmacokinetic modeling; and
3) Confirmed the unique proprietary formulation innovations of recently granted US and EU patents that increase circulating concentrations of oxypurinol.
ADPKD is a rare disease that affects more than 10 million people worldwide.1.2 ADPKD is usually diagnosed based on the expansion of fluid-filled cysts in the kidneys. Over time, the increasing number and size of cysts can contribute to structural and functional changes in the kidneys and are frequently accompanied by chronic pain, a common problem in patients with ADPKD.3 Cyst expansion is thought to compress healthy functional tissues surrounding the cysts and contribute to further loss of kidney function, fibrosis, impaired nutrient exchange, and impaired kidney function, accompanied later end-stage renal failure.1 For people with progressive ADPKD, treatment recommendations include antihypertensive therapy, dietary restrictions, and, for a limited percentage of appropriate patients, drug therapy.4 New, more widely applicable therapies to effectively slow the decline of renal function in ADPKD are needed.
About XORTX Therapeutics Inc.
XORTX is a pharmaceutical company with two clinically advanced products in development: 1) our flagship XRx-008 program for ADPKD; and 2) our secondary program in XRx-101 for acute kidney injury and other acute organ injury associated with coronavirus/COVID-19 infection. Additionally, XRx-225 is a preclinical-stage program for type 2 diabetic nephropathy. XORTX is working to advance its products into clinical development that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit the production of uric acid. At XORTX, we are dedicated to developing medicines to improve the quality of life and future health of patients. Additional information about XORTX is available at www.xortx.com.
|For more information, please contact:|
|Allen Davidoff, CEO||Nick Rigopulos, Director of Communications|
|[email protected] or +1 403 455 7727||[email protected] or +1 617 901 0785|
The TSX Venture Exchange and the Nasdaq have neither approved nor disapproved of the contents of this press release. No stock exchange, securities commission or other regulatory authority has approved or disapproved of the information contained herein.
- Wiley C., Kamat S., Stelhorn R., Blais J., National date analysis to determine the incidence and diagnosis of autosomal dominant polycystic kidney disease in the United States, Kidney Disease, 5(2): 107- 117, 2019
- Bergmann C., Guay-Woodford LM, Harris PC, Horie S., Peters DJ, Torres VE, polycystic kidney disease, Nat Rev Dis Primers. 4(1): 50, 2018
- Gimpel C., Bermann C., Bockenhauer D., et al., International consensus statement on the diagnosis and management of autosomal dominant polycystic kidney disease in children and young people, Nat Rev Nephrol 15(11):713 -726, 2019
This press release may contain express or implied forward-looking statements pursuant to Canadian and United States federal securities laws. These forward-looking statements and their implications are based solely on the current reasonable expectations of XORTX’s management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in these forward-looking statements. . Except as otherwise required by law, XORTX undertakes no obligation to issue revisions or updates to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen events. More detailed information on the risks and uncertainties affecting XORTX is contained in the most recent annual information form filed by the company and in the management report for its last financial reporting period filed on the company’s SEDAR profile (www.sedar.com ) and under the heading “Risk Factors” in XORTX’s registration statement on Form F-1 filed with the Securities and Exchange Commission (“SEC”) available at the SEC’s website, www.sec. gov.