Urica Therapeutics Announces Topline Data from the Phase 1 Clinical Trial Evaluating Dotinurad in Healthy Volunteers in the United States

Data from Phase 1 clinical trial in healthy volunteers show comparable pharmacokinetic, pharmacodynamic and safety profile between U.S. and Japanese healthy subjects

Initiating Phase 1b clinical trial in gout patients in the U.S. and expect to begin pivotal clinical trials in 2024

MIAMI, June 29, 2023 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary company focused on the development and commercialization of pharmaceutical products to treat gout and other conditions associated with hyperuricemia, today announced topline data from the Phase 1 clinical trial evaluating dotinurad in healthy volunteers in the United States (“U.S.”).

The randomized, placebo-controlled Phase 1 clinical trial evaluated the safety, tolerability, pharmacokinetics (“PK”) and pharmacodynamics (“PD”) 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 (“sUA”) 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.

Jay D. Kranzler, M.D., Ph.D., Urica’s Chairman and Chief Executive Officer, said, “We are encouraged that the data from our Phase 1 clinical trial in U.S. healthy volunteers show comparable pharmacokinetic, pharmacodynamic and safety profiles between U.S. and Japanese healthy subjects. Dotinurad has been marketed in Japan since 2020 and we are poised to leverage the extensive Japanese clinical and safety data to accelerate U.S. development and bring dotinurad to U.S. gout patients with continued unmet need to further lower serum uric acid levels and potentially reduce gout flares and tophi formation. We are initiating a Phase 1b clinical trial in gout patients in the U.S. this summer and expect to begin pivotal clinical trials in 2024.”