XORTX Announces Results from Mount Sinai’s COVID-19 Clinical Study

Early, High Uric Acid is Independently Associated with Acute Kidney Injury and Mortality in COVID-19

CALGARY, Alberta, Oct. 14, 2021 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (CSE: XRX | NASDAQ: XRTX), a pharmaceutical therapeutics company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce and share the results of an American Society of Nephrology Kidney Week abstract by Dr. Steven Coca and team at Mount Sinai Hospital Network and Icahn School of Medicine, that will be published online Friday, October 15, 2021. This study was sponsored by XORTX Therapeutics Inc. and the reported findings support the provisional patent and applications filed by XORTX announced March 2020 and March 2021.

This clinical study of patients hospitalized due to COVID-19 between March 1, 2020 and December 31, 2020 characterized the association between high serum uric acid levels with major adverse kidney events (MAKE), as well as cardiac injury. Since its emergence, COVID-19 has been reported to be associated in some individuals with acute injury to kidney, cardiovascular, neurological and other body systems.¹ The abstract presented online for the upcoming American Society of Nephrology presents data supporting the conclusions that “In patients admitted to the hospital for COVID-19, higher uric acid levels were independently associated with MAKE and mortality in a dose-dependent manner. In addition, hyperuricemia was associated with higher procalcitonin and troponin levels.”

Procalcitonin concentrations and troponin concentrations are often used as markers for interpretation of severity of sepsis and heart injury, respectively. ^2,3

Dr. Steven Coca commented, “Many factors are likely operative in contributing to acute kidney injury (AKI) in patients hospitalized with COVID. The findings from our study highlight the importance of ordering a serum uric acid level in hospitalized patients on admission or at the latest at the first onset of clinical AKI, as hyperuricemia may be a modifiable (i.e., treatable) risk factor for exacerbation of kidney injury.”

Dr. Allen Davidoff stated, “XORTX is pleased to be able to bring attention to this important work and acceptance of this peer-reviewed abstract as well as its presentation at the American Society of Nephrology Kidney Week meeting. The data from this clinical study supports our contention that hyperuricemia could be a key factor in acute kidney injury and now multi-organ injury in individuals hospitalized with COVID-19 infection.”

Definition: MAKE Criteria is defined as: MAKE (major adverse kidney events) is a composite of persistent renal function decline (>25% decline in eGFR), new requirement for hemodialysis, and death. MAKE was assessed 30-, 60-, or 90-days following AKI diagnosis.

About COVID-19 and Acute Kidney Injury

Acute kidney injury (AKI) has been identified as an independent risk factor for patients in-hospital mortality due to COVID-19⁵. Recent data from the United States indicates that 25-35% of patients hospitalized with COVID-19 develop AKI.^6-8 Up to 20% of those need renal replacement therapy (RRT), and the mortality rate in patients that experience AKI in the setting of COVID-19 is several-fold higher than patients without AKI.⁷ Moreover, proteinuria (69-85%) and hematuria (50-65%) are common in COVID-19.^6-8 In previous peer reviewed studies, viral infections such as influenza, when severe, can produce increased pulmonary cell debris, endothelial cell debris and serum uric acid (SUA) levels in the circulation as well as increased cytokine expression. Coronavirus infection appears to follow this pattern.

XORTX is developing XRx-101 - a therapy designed to decrease high serum uric acid levels and inhibit purine metabolism by xanthine oxidase for the treatment and prevention of AKI in individuals with acute kidney injury.

References:

1. Gupta A_Extrapulmonary manifestations of COVID-19_Nature medicine_preprint_July10_2020s41591-020-0968-3
2. Taylor R., Jones A., Kelly S., Simpson M., Mabey J., A Review of the Value of Procalcitonin as a Marker of Infection, Cureous 9(4):e1148, 2017
3. Babuin L., Jaffe A.S., Troponin: the biomarker of choice for detection of cardiac injury, CMAJ, 174(3):353, 2006
4. Billings F.T., Shaw A.D., Clinical Trial Endpoints in Acute Kidney Injury, Nephron Clin Practice, 127
   (0):89-93, 2014 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4480222/#:~:text=MAKE%20(major%20adverse%20kidney%20events,90%20days%20following%20AKI%20diagnosis.
5. Source: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
6. Hirsch JS, Ng JH, Ross DW, et al. Acute Kidney Injury in Patients Hospitalized with Covid-19. Kidney Int. 2020.
7. Chan L, Chaudhary K, Saha A, et al. Acute Kidney Injury in Hospitalized Patients with COVID-19. medRxiv. 2020:2020.2005.2004.20090944.
8. Mohamed MM, Lukitsch I, Torres-Ortiz AE, et al. Acute Kidney Injury Associated with Coronavirus Disease 2019 in Urban New Orleans. Kidney360. 2020:10.34067/KID.0002652020.

About XORTX Therapeutics Inc.

XORTX Therapeutics Inc. is a pharmaceutical company with two clinically advanced products in development – XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD), XRx-101 for Coronavirus / COVID-19 infection and XRx-225 is a pre-clinical stage program for Type 2 Diabetic Nephropathy (T2DN). XORTX is working to advance its clinical development stage products that target aberrant purine metabolism and xanthine oxidase to decrease or inhibit production of uric acid. At XORTX Therapeutics, we are dedicated to developing medications to improve the quality of life and future health of patients. Additional information on XORTX Therapeutics is available at www.xortx.com.

The CSE and Nasdaq have 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.

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. 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 October 14, 2021