Crystalys Therapeutics has advanced its global Phase III trials of dotinurad for gout treatment, with the dosing of the first subjects.
Dotinurad is a once-daily oral urate transporter 1 (URAT1) inhibitor being evaluated for potential best-in-class efficacy and safety.
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The multi-centre, randomised, double-blind RUBY and TOPAZ studies are assessing the therapy’s performance against allopurinol in adults with hyperuricemia associated with tophaceous gout (TOPAZ), and gout (RUBY).
RUBY will evaluate dotinurad in nearly 500 subjects once daily for up to 64 weeks.
The TOPAZ study will include around 250 participants with tophaceous gout. They will be treated with the same regimen for up to 76 weeks.
Both trials aim to evaluate the safety and efficacy of the therapy.
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By GlobalDataCrystalys Therapeutics president and CEO James Mackay said: “Dosing the first patients in our Phase III RUBY and TOPAZ studies marks a significant milestone for Crystalys and for the gout community.
“Despite existing therapies, many patients continue to experience uncontrolled disease. Dotinurad’s differentiated profile offers the potential to help improve disease symptoms for these patients.
“These studies are designed to confirm its best-in-class potential while supporting future regulatory filings in the US and Europe. We are proud to be advancing this important programme and bringing a new, effective, and well-tolerated treatment option closer to patients in need.”
Gout is the most prevalent type of inflammatory arthritis and is a condition that can be extremely debilitating for individuals. It is marked by abrupt, intense episodes of pain, redness, swelling and tenderness in one or more joints.
The disease is caused by an excess of uric acid in the body, referred to as ‘hyperuricemia,’ which leads to the accumulation of uric acid crystals and inflammation, resulting in tophaceous gout in individuals with chronic or inadequately treated conditions.
