XORTX Provides Overview and Update of Key Activities

CALGARY, Alberta, April 30, 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, confirms that the Company has filed its audited financial statements and related management’s discussion and analysis for the year ended December 31, 2019. The Company’s MD&A highlights the significant milestones accomplished by XORTX in its second year as a listed public company. Both of XORTX’s advanced clinical programs are focused on treating progressive kidney disease and with the addition of the newly announced coronavirus / COVID-19 program – XRx-101, the Company is now positions to develop this therapy for acute kidney injury due to coronavirus / COVID-19 infection.

Dr. Allen Davidoff, Founder and CEO of XORTX stated:

“2019 was an active year with a number of important advancements and we are encouraged by the opportunities that lie ahead for XORTX. Our recently announced coronavirus / COVID-19 program to suppress viral infection and acute kidney injury offers a novel and promising opportunity to treat those most severely affected by this serious challenge and join the global community in battling this disruptive health challenge.”

“The recent closing of the non-brokered private placement represents an important step forward for the Company and one that will accelerate our program development and progress toward partnering these important unmet medical needs.”

The following summarizes the advancements made in 2019 to date in XORTX’s three programs:

XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD):

• Growing outreach to key polycystic disease physicians and patient advocacy groups to advance the XRx-008 program toward a phase 3 registration trial;
  
  
• XRX-008 program further validated by evidence of a new mechanism of injury in polycystic kidney disease, this study showed that uric acid and oxalate crystals may play a key role in the initiation of new kidney cysts and accelerating the growth of those cysts as well as in the generation of kidney stones in individuals with ADPKD;
  
  
• Advanced Orphan Drug Designation (“ODD”) documents for completion of filing with the FDA for XRx-008 for the treatment of progressive kidney disease due to ADPKD;
  
  
• Introduced Dr. Anjay Rastogi, UCLA to XORTX’s Clinical Advisory Board; and
  
  
• Initiated and ongoing discussions with pharmaceutical company partners for this program.

XRx-101 for Coronavirus COVID-19 Infection:

• Completed strategic assessment and consultation of key Oxypurinol evidence, pharmacology, toxicology and applicability to fight coronavirus / COVID-19;
  
  
• Announced XRx-101 program to suppress viral infection and symptoms associated with moderate to severe infection and prevent acute kidney injury; and
  
  
• Initiated out reach to key thought leaders and clinical study sites world wide to support program development.

XRx-221 (TMX-049) for Type 2 Diabetic Nephropathy (T2DN):

• Advanced multiple documents including negotiating the definitive agreement under the Letter of Intent for the co-development of TMX-049 with Teijin Pharma Limited (“Teijin”); and
  
  
• Announced positive, statistically significant phase 2a clinical trial results showing the benefit of xanthine oxidoreductase inhibition on proteinuria in patients with progressive kidney disease due to type 2 diabetic nephropathy.

This news release contains forward-looking information relating to, among other things, statements with respect to the potential for XRx-101 as a treatment to suppress the severity of the coronavirus / COVID-19 infection. 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.

About XORTX Therapeutics Inc.

XORTX Therapeutics Inc. is a biopharmaceutical company with three clinically advanced products in development – XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD), XRx-101 for Coronavirus / COVID-19 infection and XRx-221, under a letter of intent to establish a co-development program with Teijin Pharma Limited, for Type 2 Diabetic Nephropathy (T2DN). The Company has strong intellectual property rights and established proof of concept through independent clinical studies. XORTX is working to advance its clinical development stage products that target xanthine oxidase to inhibit production of uric acid. At XORTX Therapeutics, we are dedicated to developing medications to improve the quality of life and future of patients. Additional information on XORTX Therapeutics is available at www.xortx.com.

In assessing opportunities, XORTX relies upon Company scientific expertise and its clinical advisory board composed of industry thought leaders and scientific publications within peer and non-peer reviewed publications to evaluate and advise on drug development programs. XORTX is led by Dr. Allen W. Davidoff, PhD who prior to founding XORTX had 15 years drug development experience with Stem Cell Therapeutics Corp. (co-founder, Chief Scientific Officer and Vice President, Product Development) and Cardiome Pharma Corp. (Senior Scientist and Head of Pharmacology). Dr. Davidoff has a broad range of clinical and regulatory experience in pharmaceutical R&D including two investigational new drug (“IND”) applications or supplemental IND’s, two phase 1 studies (4 multi-country), seven phase 2 studies, and one NDA.  

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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. In particular, this news release contains forward-looking information relating to, among other things, statements with respect to the potential for XRx-101 as a treatment to suppress the severity of the coronavirus / COVID-19 infection. 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 including that the products developed by the Company will require approval from Health Canada and equivalent organizations in other countries before their sale can be authorized.  These risks and uncertainties 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 30, 2020