Crystalys Therapeutics Emerges with $205M Series A to Advance Gout Treatment

Crystalys Therapeutics, a San Diego-based biotech company, has burst onto the scene with a substantial $205 million Series A financing round, signaling a significant development in the treatment of gout. The company, founded in 2022, is leveraging its experienced leadership team and a promising drug candidate to address unmet needs in gout therapy.

Veteran Team Tackles "Unfinished Business" in Gout Treatment

At the helm of Crystalys is CEO James Mackay, Ph.D., an AstraZeneca alum with a track record in developing URAT1 inhibitors for gout. Mackay previously led the development of Zurampic (lesinurad), the first URAT1 inhibitor approved in the U.S. and Europe. However, Zurampic was voluntarily withdrawn from the market due to business reasons and safety concerns, including a black box warning for acute renal failure.

"We always felt like it was unfinished business," Mackay stated, emphasizing his team's determination to develop a safer and more effective gout treatment. Joining Mackay are co-founders Nihar Bhakta, M.D., as Chief Medical Officer, and DeAnne Reid as Executive Director of Operations and Business Development. The leadership team also includes Ashwin Ram, M.D., as Chief Operating Officer, bringing extensive experience in managing new companies.

Dotinurad: A Promising Second-Line Treatment for Gout

Crystalys is focusing its efforts on dotinurad, a once-daily URAT1 inhibitor that has already gained approval in several Asian markets. The drug targets one of the two primary mechanisms of hyperuricemia, which leads to gout – specifically, the inability to excrete enough uric acid from the body.

Mackay explained the significance of this approach: "The standard of care addresses the production side of that equation. It does not address the main reason that people develop gout, which is the lack of excretion." Current first-line treatments, such as allopurinol, have been on the market for over 60 years, highlighting the need for new therapeutic options.

Global Phase 3 Trials and Market Positioning

The newly secured funding will support two global Phase 3 trials for dotinurad. One trial will focus on gout flare, a primary symptom of the condition, while the other will investigate the resolution of tophi, uric acid deposits that form on joints. Both trials are currently in the patient screening phase.

Crystalys aims to position dotinurad as a specialty care treatment, with rheumatologists as the primary prescribing physicians. The company is targeting regions where dotinurad has not yet secured approval, potentially filling a significant gap in second-line treatment options for patients who do not respond to first-line therapies.