DENVER, Colo. (247marketnews.com) -- XORTX Therapeutics (NASDAQ:XRTX) is preparing a Canadian clinical-trial application for its experimental gout treatment, XORLO, as the biotech seeks to accelerate clinical development, strengthen its regulatory strategy and attract potential commercialization partners.

XORTX Therapeutics is widening its regulatory ambitions for XRx-026, its lead gout drug candidate, with plans to submit a Clinical Trial Application (CTA) to Health Canada. The move could give the company another route to generate clinical data for its planned U.S. New Drug Application (NDA), while extending its strategy beyond a single regulatory market.

At the center of the program is XORLO, XORTX’s proprietary formulation of oxypurinol, a xanthine oxidase inhibitor designed to reduce uric acid production. The company plans to evaluate the treatment in its two-part XRX-OXY-102 clinical study, with the first part expected to be conducted in Canada. According to management, the study is intended to build on previously reported positive clinical results and further characterize the commercial tablet formulation.

XORTX cites approximately 9.2 million Americans living with gout, while global cases are projected to rise significantly over the coming decades. Although allopurinol remains the recommended first-line treatment, some patients cannot tolerate it, leaving room for alternative therapies. Febuxostat is another established option, but its cardiovascular safety warning has complicated its market position.

XORLO is being developed to address that treatment gap with what XORTX describes as a differentiated safety and efficacy profile.

“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, XORTX’s co-chief executive officer.

Management also says it has received increased inquiries from potential commercialization partners in multiple jurisdictions.

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