We received XORTX Therapeutics Inc. and we are glad to publish the following press release:
“XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, is pleased to provide an outline of its anticipated Clinical Trial Application (“CTA”) submission to Health Canada for the XRx-026 gout program. The filing supports the Company’s planned two-part clinical study, XRX-OXY-102, evaluating XORLOTM, the Company’s proprietary formulation of oxypurinol, a xanthine oxidase inhibitor, for the treatment of gout. Conducting the first part of the XRX-OXY-102 clinical study in Canada is expected to enable the Company to accelerate the delivery of key clinical data in support of its planned New Drug Application (“NDA”) filing with the U.S. Food and Drug Administration (the “FDA”) for marketing approval.
Recent drug development team activities have included parallel preparation of the CTA for filing with Health Canada. The application describes the Company’s clinical development plan for XRx-026 and its intention to advance the program toward regulatory approval in Canada in parallel with its planned NDA filing with the FDA. Part one of the XRX-OXY-102 clinical trial builds upon the previously reported positive clinical results for the proprietary XORLO™ formulation and extends characterization of the commercial tablet form.
“Advancing our Clinical Trial Application with Health Canada is expected to enable more efficient clinical plan execution and extends our regulatory strategy for XRx-026 globally,” said Dr. Allen Davidoff, Co-Chief Executive Officer of XORTX, who added, “Gout is a growing global burden, and approaches that make more efficient use of our capital, personnel and time are expected to accelerate the availability of XORLO™ to patients wherever the need exists. This, in turn, is anticipated to enhance the overall value of the XRx-026 program for the Company and its shareholders.”
As the XRx-026 program has advanced, the Company has received increased inquiries from potential commercialization partners in a number of jurisdictions. The Company has not entered into any agreement with any such party, and there can be no assurance that any of these discussions will result in a transaction. XORTX looks forward to providing further updates regarding the XRx-026 drug development program as it advances toward the planned CTA and NDA filings.
About Hyperuricemia and Gout
In the United States, approximately 44 million individuals have uric acid levels above the normal range, with 9.2 million individuals living with gout1. Gout is associated with severe pain, reduced quality of life2, decreased physical function3, increased healthcare costs4, and lost economic productivity5. It is also strongly associated with metabolic syndrome5, myocardial infarction6,7, Type 2 diabetes mellitus8, chronic kidney disease9, and premature mortality6,10,11. Importantly, the global prevalence of gout is increasing, with cases expected to increase 70% over the next 25 years*.
* https://pubmed.ncbi.nlm.nih.gov/38996590/
About the XRx-026 Program and XORLO™
The XRx-026 program is developing XORLO™, the Company’s proprietary formulation of oxypurinol, to treat individuals with gout. Oral xanthine oxidase inhibitors (“XOIs”) are the current standard of care for treating hyperuricemia-associated gout. Allopurinol is the recommended first-line therapy for gout; however, limitations remain: approximately 3–5% of patients cannot tolerate allopurinol. An alternative XOI, febuxostat, at one time achieved annual peak net sales >US$450 million, and now carries a boxed warning for cardiovascular risk which has substantially decreased its use and sales. XORLO™ is designed to address this unmet need by providing an alternative therapeutic option with a differentiated safety and efficacy profile. Advancement of XRx-026 through the planned CTA and NDA filings is a strategic priority for XORTX.”
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