Urica is a clinical-stage biopharmaceutical company that focuses on the development and commercialization of pharmaceutical products to treat gout. Gout is caused by high levels of uric acid, which can result in painful joints and lesions named tophi which result from an inflammatory response to urate crystals. High uric acid levels (hyperuricemia), also is a risk factor for certain cardiovascular and kidney diseases. Although there are currently drugs on the market to treat gout by lowering uric acid levels, most patients’ uric acid levels and resultant gout flares are poorly controlled.
In May 2021, Urica and Fuji Yakuhin Co. Ltd. entered into an agreement to develop Dotinurad in North America and Europe. Dotinurad is a potential best-in-class urate transporter (URAT1) inhibitor for gout and possibly other conditions associated with hyperuricemia, lowering blood uric acid levels by selectively inhibiting 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 or drug interactions. Over 1,000 Japanese patients have been treated safely with Dotinurad and it is currently in Phase 3 clinical trials in China.