Fortress Biotech’s Urica announces data from Phase 1 trial on dotinurad

Urica Therapeutics, a Fortress Biotech subsidiary company, announced topline data from the Phase 1 clinical trial evaluating dotinurad in healthy volunteers in the United States. The randomized, placebo-controlled Phase 1 clinical trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of dotinurad in U.S. healthy subjects. Dotinurad was shown to be safe and well tolerated with no severe adverse events observed at any dose level. No drug-related adverse events were observed at doses of 1mg, 2mg, and 4mg, which are all approved and marketed doses in Japan. The PK profile in U.S. subjects was comparable to that of Japanese subjects with all tested doses for time to peak serum drug concentration, peak serum drug concentration and drug serum half-life. Pharmacodynamic data from the Phase 1 trial were also comparable to the Japanese data where over 1,000 subjects were exposed to dotinurad, including rapid and significant serum uric acid reduction. Up to 90% of sUA reduction was observed within four days since the start of treatment. Increase of urine uric acid excretion was also observed following dotinurad treatment, which confirms its mechanism of action.