New updates have been reported about Crystalys Therapeutics (CRYST)
Elevate Your Investing Strategy:
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
Crystalys Therapeutics, a clinical-stage biopharmaceutical company, has commenced dosing in its pivotal Phase 3 trials, RUBY and TOPAZ, for their lead candidate, dotinurad. This next-generation URAT1 inhibitor is being evaluated for its safety and efficacy in treating hyperuricemia associated with gout and tophaceous gout. The RUBY study will involve approximately 500 patients, while the TOPAZ study will include around 250 patients, with both trials spanning up to 64 and 76 weeks, respectively. These trials aim to position dotinurad as a best-in-class treatment, addressing the significant unmet needs in gout management, especially for patients who do not respond to first-line therapies.
James Mackay, CEO of Crystalys Therapeutics, emphasized the importance of these trials in confirming dotinurad’s potential to improve symptoms for gout patients. The company is targeting future regulatory filings in the U.S. and Europe, with the goal of providing a new, effective treatment option. Dotinurad has already received regulatory approval in several Asian markets, including Japan and China, based on its promising safety and efficacy profile. Crystalys Therapeutics, headquartered in San Diego, is advancing these global Phase 3 trials as part of its strategic efforts to transform gout treatment and meet the critical needs of patients worldwide.