Core Insights - XORTX Therapeutics Inc. is preparing for a Type B meeting with the FDA to discuss the XRx-026 program for gout, aiming to confirm its readiness for a New Drug Application (NDA) submission [1][2] - The XRx-026 program focuses on XORLOTM, a proprietary formulation of oxypurinol, which addresses unmet medical needs in gout treatment [4] - The company anticipates that advancing the XRx-026 program will lead to a revenue-positive state for XORTX [2] Company Overview - XORTX is a late-stage clinical pharmaceutical company focused on innovative therapies for progressive kidney disease and gout [1] - The company has three clinically advanced products: XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney injury [8] Gout and Hyperuricemia Context - Approximately 44 million individuals in the US have elevated uric acid levels, with gout affecting about 9.2 million people [3] - Gout is linked to significant morbidity, including severe pain and reduced quality of life, and is associated with various health conditions such as metabolic syndrome and chronic kidney disease [3] XRx-026 Program Details - The XRx-026 program is developing XORLOTM, which aims to provide an alternative to existing xanthine oxidase inhibitors (XOIs) like Allopurinol and Febuxostat [4] - Allopurinol is commonly prescribed but not tolerated by 3-5% of patients, while Febuxostat faced a decline in use due to safety concerns [4] FDA Meeting Insights - Type B meetings with the FDA are designed to discuss the development status of drug applications and confirm any additional information needed for marketing approval [5]
XORTX Announces Update for Discussion with the FDA