Crystalys Therapeutics Secures $130 Million in Series B Funding to Accelerate Late-Stage Development of Dotinurad for Gout
Dotinurad Poised for Global Expansion Following Success in Asia
Crystalys Therapeutics has completed a $130 million Series B financing round to advance the global clinical development program for dotinurad, a novel treatment for gout. Dotinurad is an oral inhibitor that targets urate transporter 1 (URAT1) to enhance uric acid excretion in the kidneys. It has already been approved in Japan under the brand name URECE and has demonstrated a favorable safety and efficacy profile. This significant funding round reflects the strong interest from global investors in a de-risked asset that has already achieved regulatory approval in Asian markets.
Addressing Unmet Needs in the Gout Treatment Market
The global market for gout treatments is estimated at $3.2 billion to $4.52 billion by 2026, with a rapidly increasing patient population driven by dietary changes and an aging population. However, only about 50% of patients treated with existing first-line therapies, such as allopurinol or febuxostat (xanthine oxidase inhibitors), achieve their target uric acid levels. Febuxostat carries a Black Box Warning due to the risk of cardiovascular adverse events, limiting its use. Dotinurad, with its favorable safety profile, has the potential to become a new treatment option.
Asset Acquisition and Strong Shareholder Relationships
In July 2024, Crystalys acquired exclusive global rights to dotinurad (excluding Asia) from Urica Therapeutics, a subsidiary of Fortress Biotech (ticker: FBIO). As part of the agreement, Urica received a 35% equity stake in Crystalys and a royalty of 3% of future global sales, establishing a strong partnership. This funding round was led by Frazier Life Sciences, with participation from Wellington Management and Novo Holdings, significantly strengthening Crystalys' financial position.
Ongoing Global Clinical Trials and Commercialization Plans
The proceeds from the financing will be used to fund the ongoing global Phase 3 trials, Ruby and Topaz, as well as the Phase 2 Amethyst trial. The Ruby trial is a head-to-head comparison of dotinurad and allopurinol in patients with hyperuricemia and gout, while the Topaz trial is designed to evaluate the long-term tophus reduction effect in patients with tophaceous gout. James Mackay, CEO of Crystalys, stated that the financing provides the company with a cash runway of at least one year after the topline data from the Phase 3 trials are available, and that the company plans to pursue an IPO or a major licensing deal in the future.
The $130 million Series B financing for Crystalys Therapeutics demonstrates long-term financial stability by securing early funding for the operation of Phase 3 clinical trials aimed at proving superiority over existing standard treatments, such as allopurinol, in the global gout treatment market (estimated at $3.2 to $4.52 billion by 2026). Dotinurad, developed by Fuji Yakuhin of Japan, has already been approved as URECE in five Asian countries (including Japan and China), making it a low-risk pipeline asset with a high probability of success in Phase 3 trials. With the market withdrawal of lesinurad (Zurampic) and the FDA warning label restrictions on febuxostat due to cardiovascular side effects, there is a high unmet global need for a new, highly safe URAT1 inhibitor. The successful completion of the Phase 3 Ruby and Topaz trials will not only increase the corporate value of Fortress Biotech (FBIO), a major shareholder, and Urica Therapeutics, which holds a 35% stake, but also accelerate the momentum for a potential IPO of Crystalys.
Source: FierceBiotech (rss)
https://www.fiercebiotech.com/biotech/crystalys-mines-130m-series-b-round-de-risked-gout-therapy