XORTX Announces Completion of Screening and Enrollment of Bridging Pharmacokinetic Study, Canadian Business Journal

Calgary, Alberta, November 28, 2022 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or “Company) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU) is a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat advanced kidney disease and is the last remaining We are pleased to announce the successful screening and enrollment of XRX-OXY-101 Bridging Pharmacokinetic Study (“Study”). This includes initiation of medication for all subjects enrolled in Part 4 of the study. This study was designed to characterize the improved bioavailability of various formulations, assess the effect of dose on exposure, and the safety and pharmacokinetic properties of multiple doses of our proprietary oxypurinol formulation. increase.

XORTX CEO Dr. Allen Davidoff said: ), led by an experienced research and development team, allowed us to complete the enrollment of subjects in the final two parts of this clinical trial in a timely manner. Clinical trial dosing has been completed and additional topline results from the final two parts of the trial are expected to be announced in the near future. The key data from this study will be essential for pharmacokinetic modeling and safe dose selection for individuals in his planned Phase 3 clinical trial of XRX-OXY-301. ”

About the XRX-OXY-101 study

The XRX-OXY-101 is designed with four key objectives. 2) Determine the effect of food on the bioavailability of selected formulations. 3) to determine the effect of increased dose ranges on the bioavailability of the selected formulation; 4) to determine the safety and pharmacokinetics of multiple doses of the selected formulation. Knowledge gained during the conduct of this clinical trial will provide guidance on the selected formulations and oral dosing regimens necessary to reach and maintain target circulating concentrations of oxypurinol.

About the XRx-008 Program

XORTX’s flagship program, XRx-008, delivers the xanthine oxidase inhibitor oxypurinol at concentrations sufficient to substantially inhibit abnormal purine metabolism in the kidneys of patients with advanced renal disease due to ADPKD, reducing uric acid in the circulation. designed to inhibit the production of Oxypurinol is a purine-based xanthine oxidase inhibitor with key pharmacological properties that make it ideal for administration to patients with ADPKD. Key pharmacological attributes include:

1/ Ability to act in circulation, kidney and cardiovascular tissue to inhibit the production of uric acid. thereby weakening the damaging mechanisms and accelerating the effects of her XO on advancing disease.

2/ XORTX’s unique Oxypurinol formulation significantly improves the absorption of Oxypurinol. Metabolism of oxypurinol is minimal and is subsequently excreted unchanged, resulting in excellent tolerance of this xanthine oxidase inhibitor.
Building on these key attributes, the XRx-008 program offers an effective and well-tolerated treatment regimen, and is a potent xanthine oxidase inhibitor to slow the accelerated decline in renal function during ADPKD progression We look forward to the opportunity to provide

About ADPKD

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 increased number and size of cysts can contribute to structural and functional changes in the kidney, often accompanied by chronic pain, a common problem in ADPKD patients.³ Enlargement of the cyst compresses healthy, functioning tissue surrounding the cyst and is thought to contribute to further loss of renal function, fibrosis, impaired trophic exchange, and renal dysfunction, later associated with end-stage renal disease. .¹ Treatment recommendations for patients with ongoing ADPKD include antihypertensive therapy, dietary restrictions, and drug therapy in a limited proportion of suitable patients.^Four New, more widely applicable therapies are needed to effectively slow the decline of renal function in ADPKD.

In other news, the Company announced that it has granted certain officers and consultants of the Company a total of 70,000 options to purchase shares of the Company’s common stock pursuant to the Company’s Stock Option Plan. Options granted are exercisable for 5 years at $1.38.

About XORTX Therapeutics Inc.

XORTX is a pharmaceutical company developing two clinically advanced products. 2) his XRx-101 secondary program for acute renal and other acute organ injury associated with coronavirus/COVID-19 infection; Additionally, XRx-225 is a preclinical program for type 2 diabetic nephropathy. XORTX is committed to developing clinical stage products that target abnormal purine metabolism and xanthine oxidase to reduce or inhibit uric acid production. At XORTX, we are dedicated to developing medicines to improve patients’ quality of life and future health. Additional information about XORTX is available at www.xortx.com.

References:

1. Wiley C., Kamat S., Stelhorn R., Blais J., A 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
2. Bergmann C., Guay-Woodford LM, Harris PC, Horie S., Peters DJ, Torres VE, Polycystic Kidney Disease, Nat Rev Dis Primers. 4(1): 50, 2018
3. https://pkdcure.org/living-with-pkd/chronic-pain-management/
4. 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 Adolescents, Nat Rev Nephrol 15(11):713-726, 2019

Neither TSX Venture Exchange nor Nasdaq endorse or deny the contents of this news release. No stock exchange, securities commission or other regulatory authority has approved or disapproved of the information contained herein.

Forward-Looking Statements

This press release contains forward-looking statements, either express or implied, under the United States federal securities laws. These forward-looking statements and their impact are based solely on the current expectations of XORTX’s management and may cause actual results to differ materially from those set forth in the forward-looking statements. Subject to many factors and uncertainties. Except as otherwise required by law, XORTX does not publicly release revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. shall not be obligated to release to More detailed information regarding the risks and uncertainties affecting XORTX is included under the heading “Risk Factors” in XORTX’s registration statement on Form F-1 filed with the SEC. ), and our reports, public documents and other filings with the Securities Commission of Canada and other regulatory bodies, available at www.sedar.com Available.

CBJ Newsmaker