Core Viewpoint - XORTX Therapeutics Inc. has requested a Type C meeting with the FDA to discuss the XRx-026 program for gout treatment, indicating readiness for a New Drug Application (NDA) submission for its proprietary drug formulation, XORLO [1][2]. Company Overview - XORTX is a late-stage clinical pharmaceutical company focused on innovative therapies for progressive kidney disease and gout, with three clinically advanced products: XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney injury [6]. XRx-026 Program Details - The XRx-026 program is developing XORLO, a proprietary formulation of oxypurinol aimed at treating gout, particularly for patients intolerant to allopurinol [4]. - The program has progressed sufficiently to warrant a review with the FDA, with the meeting expected to occur within 75 days of the request [2]. Gout Prevalence and Impact - Approximately 44 million individuals in the US have elevated uric acid levels, with about 9.2 million suffering from symptomatic gout, which is linked to severe pain and increased healthcare costs [3]. - Gout is associated with serious health conditions, including myocardial infarction and chronic kidney disease, impacting quality of life and economic productivity [3]. Current Treatment Landscape - Oral xanthine oxidase inhibitors (XOIs) are the preferred treatment for gout, with allopurinol being the most commonly prescribed, totaling around 3.3 million prescriptions annually in the US [4]. - Febuxostat, another XOI, had peak sales of approximately US$450 million but faced a decline due to safety concerns, highlighting the need for alternatives like XORLO [4].
XORTX Commences Gout Program NDA Discussions with the FDA