Crystalys Therapeutics has dosed the first patients in a Phase II trial evaluating a treatment for difficult-to-treat gout. 

The trial will evaluate dotinurad, a next-generation, once daily, oral URAT1 inhibitor with the potential to deliver best-in-class safety and efficacy for the treatment of gout, particularly in patients with limited treatment options. 

The study will consist of two consecutive parts: a 24-week placebo-controlled period where participants will take either dotinurad or placebo, followed by a 12-week active treatment period where all participants will take dotinurad. 

Gout is the most common form of inflammatory arthritis, characterised by sudden, severe attacks of pain, swelling, redness and tenderness in one or more joints. This disease arises from excess uric acid in the body, known as ‘hyperuricemia,’ which causes buildup of uric acid crystals and inflammation, which can lead to tophaceous gout in people with chronic or undertreated disease. 

“Dosing the first patient in our Phase II AMETHYST study marks an important milestone for Crystalys and for those living with gout who have limited treatment options,” said James Mackay, President and Chief Executive Officer of Crystalys Therapeutics.  

“This study builds on our broader clinical development programme, including the ongoing Phase III RUBY and TOPAZ trials, and reinforces our commitment to advancing comprehensive treatment options for patients with gout.” 

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