XORTX Announces Notice to Grant European Patent

Patent Supporting Diabetic Nephropathy – XRx-221

CALGARY, Alberta, April 06, 2021 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (CSE: XRX) (OTCQB: XRTXF), a biopharmaceutical company focused on developing therapeutics for the treatment of progressive kidney disease, is pleased to announce that it has received notification of intention to grant the patent “Compositions and Methods for Treatment and Prevention of Hyperuricemia Related Health Consequences” by the European Patent Office for this PCT international application. The patent covers compositions and methods for the prevention and treatment of diabetic nephropathy (DN) using uric acid lowering agent and specifically xanthine oxidase inhibitors. Aberrant purine metabolism and specifically, chronically increased serum uric acid concentrations have been associated with kidney disease progression.

Dr. Allen Davidoff, CEO commented, “This patent relates to certain compositions and uses of uric acid lowering agents to treat diabetic nephropathy and provides XORTX with protection in the 31 markets within the European region. With this newly allowed patent, XORTX now has five granted patents in the US and/or EU covering compositions and uses of uric acid lowering agents for the treatment of chronic progressing kidney disease, hypertension, insulin resistance, and diabetic nephropathy.”

About XRx-221

XORTX’s program, XRx-221, for DN, is a small molecule drug development program focused on bringing therapies to patients to treat progression of chronic kidney disease (CKD) due to diabetes. It broadens our intellectual property platform in key European jurisdictions in connection with our mission to develop and clinically advance drugs that manage purine metabolism and chronically increased serum uric acid with the goal of slowing the progression of diabetic nephropathy.

About Chronic Kidney Disease (CKD) and Diabetic Nephropathy (DN)

CKD, also called chronic kidney failure, describes the gradual loss of kidney function. The kidneys filter wastes and excess fluids from blood, which are then excreted in the urine, but when CKD reaches an advanced stage, dangerous levels of fluid, electrolytes and wastes can build up in the body. In the early stages of CKD, there may be few signs or symptoms and CKD may not become apparent until kidney function is significantly impaired. Treatment for CKD focuses on slowing the progression of the kidney damage, usually by controlling the underlying cause. CKD can progress to end-stage kidney failure, which is fatal without artificial filtering (dialysis) or a kidney transplant. More than one in seven, or 15% of US adults being ~37 million people, are estimated to have CKD^1, and of those, it is estimated that diabetic nephropathy (DN) contributes half of all individuals. Sadly, there are few approved drugs to treat or slow progressing CKD or DN.

In the United States today, there are approximately 34 million individuals with diabetes, and nearly 11 million individuals with DN and worldwide greater than 110 million. Current projections suggest that in the next 15 years the population of individuals with diabetes will double from ~350 million today to nearly 650 million by 2035². Equally concerning, the worldwide population of individuals with DN is expected to rise proportionately to ~175 million individuals. XORTX recognizes the substantial unmet medical need and the opportunity to bring a potentially first-in-class and best-in-class therapeutic treatment to patients with T2DN. XORTX estimates the US market opportunity for XRx-221 would be more than the estimated $2B peak sales revenue per year.

References:

1. Chronic Kidney Disease in the United States, 2021 – www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html#
2. Alicic RZ, et al, Diabetic Kidney Disease, Clin J Am Soc Nephrol, 12(12)2032-2045, 2017
3. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
4. https://www.diabetesresearch.org/diabetes-statistics#:~:text=34.2%20million%20people%2C%20or%2010.5,%2C%20economic%2C%20and%20ethnic%20backgrounds

About XORTX Therapeutics Inc.

XORTX Therapeutics Inc. is a biopharmaceutical company focused on developing therapeutics for the treatment of chronic progressing kidney disease, hypertension, insulin resistance and diabetic nephropathy. XORTX currently has three product candidates in various stages of clinical development targeting xanthine oxidase enzyme inhibition and uric acid lowering as a method of treating progressing kidney disease. At XORTX, we are dedicated to developing therapeutics designed to improve the quality of life and future of patients with kidney disease.

Neither the Canadian Securities Exchange, nor any other Canadian, US or other foreign stock exchange, securities commission or other regulatory authority has approved or disapproved the information contained herein.

This news release includes forward looking statements that are subject to assumptions, risks and uncertainties. Statements in this news release which are not purely historical are forward looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs and expectations will prove to be accurate. The Company cautions readers that all forward looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward looking statements. Readers are advised to rely on their own evaluation of such risks and uncertainties and should not place undue reliance on forward looking statements. Any forward looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward looking statements, or to update the reasons why actual events or results could or do differ from those projected in the forward looking statements. The Company assumes no obligations to update any forward looking statements, whether as a result of new information, future events or otherwise.

Released April 6, 2021