XORTX Launches XRx-101 Following the Filing of a Provisional Patent to Potentially Treat Respiratory and Kidney Disease Injury Due to Coronavirus InfectionXRx-101 – a triple action approach to suppressing COVID-19 Injury

CALGARY, Alberta, March 16, 2020 (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, with late stage clinical programs, is re-issuing its earlier press release with a clarified title pursuant to the Company’s announcement that it is exploring the potential of using XRx-101 (a new formulation of Oxypurinol) as a novel treatment for acute kidney and lung injury accompanying Coronavirus infection and specifically for the COVID-19 infection. The Company has reviewed recent studies characterizing the outbreak of COVID-19 in mainland China. These published reports clearly illustrate that acute kidney injury and acute pulmonary injury are key factors in the most serious cases of COVID-19 hospitalization and death. XORTX has filed new intellectual property rights for XRx-101 for the treatment of respiratory and kidney disease due to viral infection.

In addition, studies of Coronavirus infections show that SARS and MERS and specifically COVID-19 can be frequently accompanied by pneumonia, acute kidney injury, proteinuria and hematuria^1,2. Acute kidney injury (“AKI”) has been identified as an independent risk factor for patients’ in-hospital mortality due to COVID-19 as well as other Coronavirus infections². Early reports suggested a lower incidence (between 3% to 9%) of AKI in those with COVID-19 infection^2,6,8. Recent reports, however, have shown a higher frequency of renal abnormalities. A study of 59 patients with COVID-19 found that 34% of patients developed massive albuminuria on the first day of admission and 63% developed proteinuria during their stay in hospital⁹.

Based on these recent studies, the Company believes that its Oxypurinol formulation, XRx-101, has the potential to be a front-line treatment for severe cases of Coronavirus and the ability to decrease morbidity and mortality in hospitalized patients. Coronavirus infections have high mortality rates¹ with SARS, MERS and COVID-19 having rates of 10%, 37% and 4%, respectively. While the COVID-19 mortality rate is currently reported to be lower than SARS and MERS, COVID-19 is more contagious than SARS and MERS. Management’s belief that XRx-101 is a possible treatment for COVID-19 is based upon its potential anti-viral properties, and historic animal and human data that show that acute tissue injury can lead to rapid accumulation of uric acid and uric acid crystals that aggregate in kidneys and induce acute kidney injury^3,4. When acute kidney injury accompanies pneumonia, post-discharge outcomes are worse than either diagnosis alone. Patients who survive a pneumonia hospitalization and develop acute kidney injury are at high risk for major adverse kidney events including death and should receive careful follow-up⁴. Perhaps more importantly, Oxypurinol has been previously studied for anti-viral properties¹⁰, a characteristic that may decrease morbidity and mortality of COVID-19. Importantly, Oxypurinol has in the past received an “Approval Letter” from the US FDA, potentially accelerating development for this purpose.

In concept, the triple action of XRx-101, as an anti-viral therapy, to decrease the production of uric acid and to increase aqueous solubility of uric acid will decrease uric acid crystal formation associated with tumor lysis “like” syndrome due to Coronavirus infection. Any agent that decreases the severity of primary or secondary pneumonia leading to acute kidney injury is potentially highly relevant.

XORTX believes that XRx-101 (a formulation of Oxypurinol) could be relevant and important for decreasing kidney and lung associated health consequences of the Coronavirus infection. Indeed, Xanthine oxidase inhibitors (XOI) have been reported to have a potent antiviral effect against influenza-A virus⁵, suggesting a third potential therapeutic method for suppressing the Coronavirus infection.

XORTX is preparing to manufacture and submit final investigative new drug (IND) applications for XRx-008 for the Company’s planned phase 3 clinical trial in Autosomal Dominant Polycystic Kidney Disease (ADPKD).

“XORTX has begun a comprehensive review of the potential for XRx-101 to be a novel treatment for Coronavirus infection and its health consequences,” commented Dr. Allen Davidoff, CEO, XORTX Therapeutics who added, “Oxypurinol is a well studied drug that is known to be clinically safe and effective at decreasing production of uric acid, as well as a potential anti-viral agent. Owing to its advanced development status, Oxypurinol could be quickly developed to help treat those most severely affected by COVID-19.”

About XORTX Therapeutics Inc.

XORTX Therapeutics Inc. is a biopharmaceutical company focused on developing innovative therapies to treat progressive kidney disease. XORTX has two lead programs to develop treatments for progressive kidney disease due to diabetes, diabetic nephropathy and polycystic kidney disease. XORTX’s XRx-008 (a proprietary reformulation of Oxypurinol) is a late stage drug development program to treat autosomal dominant polycystic kidney disease (ADPKD). TMX-049, is a late phase 2b stage program in treat type 2 diabetic nephropathy (T2DN), under a Letter of Intent, that proposes a co-development agreement with Japan’s Teijin Pharma Limited. 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.

For further information, please contact:

Allen Davidoff, CEO - adavidoff@xortx.com or +1 403 455 7727

or Erik Matthews, Corporate Communications - erik@xortx.com or +1 747 203 5240

References:

1. Saraladevi Naicker, Chih-Wei Yang, Shang-Jyh Hwang, Bi-Cheng Liu, Jiang-Hua Chen, Vivekanand Jha, The Novel Coronavirus 2019 Epidemics and Kidneys, Kidney International March 2, 2020. https://www.kidney-international.org/article/S0085-2538(20)30251-9/pdf
2. Cheng, Y, Luo R., Wang K., Zhang M., Wang Z., Dong L., Li J., Yao Y., Ge S., Xu g., Kidney Impairment is associated with in-hospital deal of Covid-19 patients, medRxiv, March 04_2020 https://www.medrxiv.org/content/10.1101/2020.02.18.20023242v1
3. Wilson FP., Tumor Lysis Syndrome, Adv Chronic Kidney Dis, 21(1)18, 2014 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4017246/
4. Chawla LS., Amdur RL., Faselis C., Kimmel PL., Palant CE., Impact of Acute Kidney Injury in Patients Hospitalized with Pneumonia, Crit Care Med, 45(4)600-606, 2017 https://www.ncbi.nlm.nih.gov/pubmed/28291091
5. Perez-Mazliah D et al, Allopurinol reduced antigen-specific and polyclonal activation of human T-cells, Frontiers in Immunology, Sept 2012
6. Wang D, Hu B, Hu C, et al. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA,2020,doi:10.1001/jama.2020.1585.
7. Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study[J]. Lancet, 2020, 395(10223): 507-513.
8. Guan WJ, Ni ZY, Hu Y, et al. Clinical characteristics of 2019 novel coronavirus infection in China. medRxiv preprint first posted online Feb. 9, 2020. https://doi.org/10.1101/2020.02.06.20020974Li Z,
9. Wu M, Guo J, et al. Caution on Kidney Dysfunctions of 2019-nCoV Patients. medRxiv preprint doi: https://doi.org/10.1101/2020.02.08.20021212.
10. El-Farrash, Youssef JM., and El-Mongy SE., Allopurinol as a potential therapeutic agent for recurrent herpes labialis, J Med Dent Sci, Jun 50(2):147-154

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.

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.