Febuxostat

Crystalys Therapeutics launched on Tuesday armed with $205 million in funding and partial rights to a gout treatment thats already approved in multiple Asian countries.The fledgling biotechnology firm, which is headquartered in San Diego, acquired U.S. and European rights to that drug, known as dotinurad, last year. Its since raised the funding necessary to start global Phase 3 studies in patients who dont respond initial therapies for the condition.James Mackay is the CEO of Crystalys Therapeutics, which acquired U.S. and European development rights to a drug already approved in parts of Asia for gout.Permission granted by Crystalys TherapeuticsSome estimates hold that nearly 56 million people around the world have gout, a form of arthritis caused by the buildup of excess amounts of uric acid in the body. The condition most commonly affects the big toe joint and is characterized by disease flare-ups or gout attacks, sudden and severe episodes of joint pain.For decades, the standard of care for patients has been a drug called allopurinol, which hinders production of uric acid. But behind that therapy the options are limited. One,febuxostat, is little used in the U.S. because of an association with a higher risk of heart problems.Another, Krystexxa, is used in people whose gout cant be held in check by other medicines and one of the reasons Amgen agreed to acquire its previous owner, Horizon Therapeutics, in 2022. The drug generated $1.2 billion in sales last year.James Mackay, Crystalys cofounder and CEO, claims that theres room for improvement. While Krystexxa is effective, use is still limited by its high cost and the need for twice-weekly infusions. And still about half of the patients who take allopurinol have uncontrolled disease. The second-line treatment space is empty, he said.Mackay has, for years, tried to fill that treatment gap. While at Ardea Biosciences and later its acquirer, AstraZeneca, he was part of the team that launched Zurampic, which the Food and Drug Administration approved in 2015. But that therapy was also linked to kidney damageand withdrawn from the market four years later. Hes since wanted to find a more potent and safer version of Zurampic.According to Mackay, that molecule is dotinurad, which, like Zurampic, blocks a key transporter protein that regulates urid acid levels. The drug was discovered by a small Japanese drugmaker called Fuji Yakuhin and approved in the country in 2020.Eisai acquired the rights to development and commercialization in China, then brought it to market there late last year. Its cleared for use in the Philippines and Thailand, too.Mackay notes that dotinurad binds more specifically to that transporter protein than Zurampic did. It also helps flush out uric acid more slowly, which should help protect the kidneys.Crystalys acquired partial rights to dotinurad from a subsidiary of Fortress Bio last July. It then persuaded the FDA to go straight into global Phase 3 testing based on the trial data generated in Asia, Mackay said.The label in Japan really has not changed in the five years it has been on the market, and that's actually very reassuring from a safety perspective, he added.Crystalys began fundraising in January and, since then, has amassed an investor syndicate of more than a dozen firms, including co-leaders Novo Holdings, SR One and Catalys Pacific. Novo Holdings also previously invested in Aristea Therapeutics, another startup Mackay founded.The company is one of a handful of biotechs working on new gout treatments. Another San Diego biotech, Arthrosi Therapeutics, has one in Phase 3 testing.We feel that the unmet medical need is so large here that even if multiple of these drugs were approved, there's certainly room for this, and patients need other treatment options, Mackay said. '

iStock, Silver Place Already approved in Japan, China and other Asian countries, Crystalys’ dotinurad works to lower serum uric acid levels. With $205 million in series A capital , California-based Crystalys Therapeutics has emerged from stealth to develop next-generation therapies for gout. The startup will use the money to back its lead asset dotinurad, for which it plans to launch global Phase III clinical trials. Discovered by Japanese firm Fuji Yakuhin, dotinurad is an orally available URAT1 blocker that lowers serum uric acid levels, preventing the formation of crystals in the joints that lead to the pain typical in gout. Dotinurad was approved in Japan in 2020 . Under an August 2021 contract , Eisai has rights to dotinurad in China and several Southeast Asian countries. The drug won Chinese approval in 2025 , backed by Phase III data demonstrating superior uric acid reduction versus Takeda’s Uloric. Dotinurad has also won marketing approvals in the Philippines and Thailand. Dotinurad’s established clinical and regulatory pro helped attract several big backers for Crystalys. The biotech’s series A was led by Novo Holdings, SR One and Catalys Pacific. Institutional investors including Alexandria Venture Investments, Lightstone Ventures and AN Venture Partners participated in the round. With its $205 million haul on Tuesday, Crystalys ranks among the highest series A raises this year. The record so far is held by obesity-focused Verdiva Bio, which in January brought in $411 million in series A proceeds. (Isomorphic Labs, a spinoff from Google’s DeepMind, raised $600 million in March , but it is unclear if this was a series A push.) More recently, U.K.-based startup Draig Therapeutics took off in June with $140 million and a goal to advance its allosteric AMPA receptor modulator DT-101 for major depressive disorder. The molecule is set to start Phase II development this year. Draig is also working on two preclinical GABA A modulators for yet undisclosed indications. A month later, radiopharma biotech Actithera debuted with $75.5 million in an oversubscribed series A push. Actithera’s lead candidate is a radioligand therapy targeting the fibroblast activation protein. The company plans to test it in multiple indications, though no specific target diseases have been named so far. Earlier this year, Merida launched with $121 million to target autoimmune and allergic conditions. The raise, announced in April, will go toward advancing Fc biotherapeutics, a class of molecules with “antibody-like” effects that selectively tag disease-causing autoantibodies for destruction.