JW Pharmaceutical announced on the 11th through a regulatory disclosure that it has received the top-line results of its multinational Phase 3 clinical trial for the gout treatment 'Epaminurad (URC102).'

[Clinical Trial Overview] The trial was designed to evaluate the efficacy and safety of epaminurad in gout patients compared to febuxostat. It was conducted as a multicenter, randomized, double-blind, active-controlled, confirmatory study, with a total of 612 subjects randomly assigned across 52 institutions in five countries: South Korea, Taiwan, Thailand, Malaysia, and Singapore.

• *[Efficacy Results]**
• The proportion of subjects with serum uric acid levels below 6mg/dL during the last three visits of the main study period was as follows:
• Epaminurad 6mg group vs. Febuxostat 40mg group: Achievement rates were 50.0% and 38.3%, respectively. The difference in response rates between the two groups was 12.0%, and the lower bound of the 95% confidence interval was higher than the non-inferiority margin (-10%), confirming both non-inferiority and superiority compared to febuxostat 40mg.
• Epaminurad 9mg group vs. Febuxostat 80mg group: Achievement rates were 59.6% and 63.3%, respectively. Although the response rate difference was -3.99%, the lower bound of the 95% confidence interval was below the non-inferiority margin, and therefore non-inferiority was not confirmed compared to febuxostat 80mg.

[Safety Results] During the main study period, a total of 697 adverse events occurred in 315 subjects. The incidence of adverse events by treatment group was 49.7% for the epaminurad 6mg group, 52.5% for the febuxostat 40mg group, 50.7% for the epaminurad 9mg group, and 53.1% for the febuxostat 80mg group, showing no statistically significant differences between the respective comparative groups. There were also no differences in adverse drug reactions or serious adverse events, and no adverse events resulted in death.

[Future Plans and Cautions] According to the company, epaminurad is an oral uricosuric agent that selectively inhibits the human urate transporter (hURAT1), thereby suppressing uric acid reabsorption in the kidneys and promoting its excretion. JW Pharmaceutical plans to proceed with the domestic new drug application for this product in the future.

Additionally, the company clarified that this disclosure date marks the receipt of the draft Clinical Study Report (CSR) and the confirmation of the Phase 3 top-line results. The company explicitly noted an investment caution, stating, "The probability that a clinical trial drug will receive final regulatory approval is known to be approximately 10%, and depending on the results of the clinical and approval processes, there is a possibility that commercialization plans may be altered or abandoned."