Crystalys Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for gout, a condition characterized by high levels of uric acid in the blood that can lead to painful arthritis flare-ups. The company has officially announced its launch, coinciding with a successful $205 million Series A financing round. This substantial funding will focus on addressing the significant unmet medical needs faced by individuals living with gout, aiming to advance the development of effective treatments.
The $205 million financing round was co-led by prominent investment firms, including Novo Holdings, SR One, and Catalys Pacific. A wide array of investors participated in the funding, reflecting strong confidence in Crystalys and its mission. Notable participants included Perceptive Xontogeny Venture Funds, Lightstone Ventures, AN Venture Partners, and funds managed by abrdn, KB Investments, Pontifax, Longwood Fund, Alexandria Venture Investments, Wedbush Healthcare Partners, and Prebys Ventures Fund. This diverse syndicate of investors brings together expertise and resources that will support the company’s strategic initiatives.
The primary focus of the funding will be to facilitate global Phase 3 clinical studies for Crystalys’s lead asset, dotinurad. Dotinurad is an advanced oral URAT1 inhibitor, designed for once-daily administration. It has shown promise as a potential best-in-class treatment for gout, combining effectiveness with an excellent safety profile. Clinical trials to date have demonstrated robust efficacy and a clearly defined safety profile, leading to the drug’s approval in several countries, including Japan, China, the Philippines, and Thailand. These approvals underscore the significance of dotinurad in addressing the needs of patients with gout.
At the helm of Crystalys is co-founder and CEO James Mackay, Ph.D., a seasoned leader in the biotech industry with more than 40 years of experience in drug development. Dr. Mackay has a remarkable history, having overseen the approval of six drugs and founded several successful companies, making significant contributions to the life sciences landscape in San Diego. His leadership is essential as he guides Crystalys in navigating the complexities of drug development and regulatory landscapes.
The team at Crystalys is comprised of talented individuals with proven track records in gout drug development and regulatory success. Co-founder Dr. Nihar Bhakta serves as the Chief Medical Officer, bringing extensive clinical and regulatory experience in the fields of immunology and inflammation. He has been integral in leading the team that secured recent FDA and EU approvals for small molecule therapies aimed at treating hyperuricemia associated with gout.
Additionally, Dr. Ashwin Ram, who serves as the Chief Operating Officer, has a background in both investing and operations leadership. His experience includes managing the formation of multiple new companies while he served as a Partner at Catalys Pacific, helping to drive innovative biotech initiatives.
The Executive Director of Operations and Business Development, Ms. DeAnne Reid, complements the leadership team with her extensive expertise in biotech and gout drug development. Ms. Reid’s experience comes from her previous roles at Ardea Biosciences and Aristea Therapeutics, where she developed a deep understanding of the complex landscape of drug development.
Together, this dedicated team at Crystalys Therapeutics is poised to make significant advancements in the treatment of gout, working diligently to meet the needs of patients and improve their quality of life through innovative therapeutic solutions.
KEY QUOTES:
“Crystalys was built to bring forward a new therapeutic option for the millions of people struggling with gout. Our lead asset, with its proven efficacy and well-defined safety profile, has already demonstrated its ability to provide meaningful relief for people living with gout. Thanks to the support of our investors, our experienced team is now well-positioned to accelerate dotinurad’s development in the US and Europe as a much needed second-line therapy for patients who do not respond adequately to first-line treatments.”
James Mackay, Ph.D., President and Chief Executive Officer of Crystalys Therapeutics
“Since its inception, Crystalys has been guided by a singular vision: uniting a world-class gout drug development team with Japan’s excellence in pharmaceutical innovation to deliver transformative therapies for patients with gout. We are proud to continue to support Crystalys as it advances dotinurad into two global Phase 3 trials.”
BT Slingsby, M.D., Ph.D., M.P.H., Co-founder and Chairman of the Board of Crystalys Therapeutics
“The clinical effectiveness of dotinurad for treating hyperuricemia associated with gout has already been well validated across 22 trials involving 1,300 subjects, and since its approval in Japan in 2020, more than 1.2 million patients have been treated with dotinurad, consistently achieving target serum uric acid levels linked to meaningful clinical benefits. Our upcoming Phase 3 trials are designed to highlight the superior efficacy of dotinurad in reducing serum uric acid levels, gout flares and tophus area.”
Nihar Bhakta, M.D., Chief Medical Officer of Crystalys Therapeutics
