JW Jungwoo Pharmaceutical Achieves Significant Results in Phase 2 Trial of New Gout Drug

JW Choongwae Pharmaceutical CI (Provided by JW Choongwae Pharmaceutical)

[Asia Economy Reporter Chunhee Lee] JW Pharmaceutical's gout treatment 'URC102' has successfully completed its late Phase 2 clinical trial by confirming statistically significant results.

JW Pharmaceutical announced on the 18th that it has successfully completed the domestic Phase 2b clinical trial of the global gout new drug candidate URC102. URC102 is a promising new drug candidate effective for gout caused by hyperuricemia, an abnormally high concentration of uric acid in the blood, and it works by promoting uric acid excretion. In 2019, the development and sales rights for the Chinese market were licensed out to Simcere Pharmaceutical.

Since April 2019, JW Pharmaceutical has been conducting a Phase 2b clinical trial involving 171 Korean gout patients at 18 major domestic hospitals including Chung-Ang University Hospital and Hanyang University Hospital to evaluate efficacy and safety and to explore the appropriate dosage.

The Phase 2b trial groups were divided into four groups: URC102 9 mg, 6 mg, 3 mg, and placebo, along with a reference group receiving Febuxostat 80 mg. They were administered orally once daily for 12 weeks.

As a result of the clinical trial, both primary and secondary efficacy endpoints were met, and high safety and tolerability were demonstrated.

The primary endpoint was the achievement rate of serum uric acid levels below 6 mg/dL at 4 weeks after drug administration. The rates were 88.9% for the URC102 9 mg group, 71.8% for the URC102 6 mg group, 54.1% for the URC102 3 mg group, and 0% for the placebo group, showing statistically significant results for all URC102 dosage groups compared to placebo. The achievement rate for the reference group receiving Febuxostat 80 mg was 84.2%.

The achievement rate of serum uric acid levels below 5 mg/dL showed similar results. This confirmed a dose-dependent response of URC102, with higher doses achieving higher endpoint rates. These results were consistently observed not only at 4 weeks but also at 8 and 12 weeks across all dosage groups.

In terms of safety and tolerability, no serious adverse drug reactions or risks were identified, and the safety profile was evaluated to be comparable to that of the placebo group.

Based on the Phase 2b results, JW Pharmaceutical plans to review domestic and international Phase 3 clinical trials and accelerate discussions on global technology licensing with multinational pharmaceutical companies.

Seong-Yeol Lee, CEO of JW Pharmaceutical, stated, “Although the incidence of gout is rapidly increasing, existing treatments are not actively prescribed due to safety concerns. Having confirmed very positive results in the late Phase 2 trial of URC102, we will develop it as a global gout new drug combining high safety and excellent efficacy.”

This content was produced with the assistance of AI translation services.