XORTX Initiates IND Preparation for XORLO™ in Gout Program

Core Insights - XORTX Therapeutics Inc. has initiated the preparation for an Investigational New Drug (IND) application for its lead program, XRx-026, aimed at treating gout, with support from Allucent, a global contract research organization [1][3] - The IND preparation will involve a thorough review of non-clinical, pharmacologic, toxicological, and regulatory progress, and is expected to be submitted in the second half of 2025 [2][3] - The FDA has outlined four critical requirements for the New Drug Application (NDA) submission for XORLO™, the proprietary formulation of oxypurinol [3][6] Company Developments - XORTX has confirmed the issuance of 73,871 common shares at US$1.54 per share, resulting in gross proceeds of approximately USD $113,547.11 during the quarter ended March 31, 2025, under its at-the-market offering [4] - The company is focused on developing innovative therapies for gout and progressive kidney disease, with three clinically advanced products in development [9] Market Context - Approximately 44 million individuals in the U.S. have elevated uric acid levels, with 9.2 million living with gout, indicating a significant market need for effective treatments [5] - The global prevalence of gout is expected to double over the next 25 years, highlighting the growing demand for new therapeutic options [5] Product Insights - The XRx-026 program is developing XORLO™, which aims to provide an alternative for patients who cannot tolerate existing xanthine oxidase inhibitors, addressing a notable gap in current treatment options [6][7] - Current standard treatments for gout have limitations, with 3-5% of patients unable to tolerate allopurinol, and febuxostat carrying cardiovascular risk warnings [6][7]