Business
Fortress Biotech Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Dotinurad for the Treatment of Gout in the United States
Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor in clinical development at Fortress’ subsidiary company, UR-1 Therapeutics
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor in clinical development at Fortress’ subsidiary company, UR-1 Therapeutics Dotinurad (URECE® tablet) was approved in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials MIAMI, May 31, 2022 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced that its subsidiary company, UR-1 Therapeutics, Inc. (“UR-1”), dosed the first patient in a Phase 1 clinical trial evaluating Dotinurad for the treatment of gout in the United States. The principal objective of this Phase 1 clinical trial is to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of Dotinurad in Western subjects. Subjects will be randomized into a placebo-controlled crossover clinical trial design to evaluate a wide range of Dotinurad doses. Lindsay A. Rosenwald, M.D., Fortress’ Chairman and Chief Executive Officer, said, “The successful dosing of the first patient in this Phase 1 clinical trial to evaluate Dotinurad for the treatment of gout is an important milestone for UR-1 and Fortress and we expect to announce topline data in the second half of 2022. Our goal is to leverage the exceptional clinical efficacy and safety profile of Dotinurad to create a superior treatment option for the nearly 10 million patients suffering from gout in the U.S. If approved in the U.S., Dotinurad has the potential to be the most potent oral therapy for lowering serum uric acid levels with an excellent safety and efficacy profile vis-à-vis earlier generations of URAT inhibitors. There is also further potential to evaluate this product candidate in other diseases, including chronic kidney disease and heart failure.” About DotinuradIn May 2021, Fortress announced an exclusive license agreement between its subsidiary, UR-1, and Fuji Yakuhin Co. Ltd. to develop Dotinurad in North America and Europe. Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor for gout and possibly other hyperuricemic indications includi...