Fortress Biotech Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Dotinurad for the Treatment of Gout in the US

Fortress Biotech, Inc. recently announced its subsidiary company, UR-1 Therapeutics, Inc., dosed the first patient in a Phase 1 clinical trial evaluating Dotinurad for the treatment of gout in the US.

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, MD, 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 US. If approved in the US, 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.”

In 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, including chronic kidney disease and heart failure. It can lower blood uric acid levels by selectively inhibiting URAT1 and uric acid reabsorption in the kidneys. 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. Its efficacy was non-inferior to Febuxostat, which has a black box warning for increased risk of cardiovascular death, and was well-tolerated with low safety risk and drug interaction. Over 1,000 Japanese patients have been treated safely with Dotinurad.

Gout is a serious, progressive and debilitating inflammatory arthritis caused by deposits of uric acid crystal in and around the connective tissue of joints, tendons and the kidneys. There are nearly 20 million diagnosed patients with gout in the US, Europe and Canada as of 2021, and it is estimated that 2 to 3 million US patients are unsatisfied with their urate-lowering therapy and their serum uric acid levels remain inadequately controlled.

UR-1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company that focuses on the development and commercialization of pharmaceutical products to treat gout and chronic kidney disease. UR-1 acquired the rights to develop and commercialize Dotinurad, a potentially best-in-class URAT1 inhibitor, in the US, UK, European Union, and Canada from Fuji Yakuhin. Dotinurad has been approved to treat gout and hyperuricemia in Japan and is currently in a Phase 1 clinical trial in the United States. UR-1 was founded by Fortress Biotech, Inc.

Fortress Biotech, Inc. is an innovative biopharmaceutical company focused on acquiring, developing, and commercializing high-potential marketed and development-stage drugs and drug candidates. The company has nine marketed prescription pharmaceutical products and over 30 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas, including oncology, rare diseases, and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca plc, City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children’s Research Hospital, Nationwide Children’s Hospital and Sentynl Therapeutics, Inc. For more information, visit www.fortressbiotech.com.