JW Pharmaceutical's Gout Drug 'Epaminurad' Succeeds in Phase 3 Trial... Aiming for Domestic Approval Next Year

JW Pharmaceutical announced on August 11 that it plans to apply for domestic product approval for its gout treatment candidate, Epaminurad, after confirming its efficacy in a multinational phase 3 clinical trial.

The trial was conducted across 52 institutions in five Asian countries and regions, namely Korea, Taiwan, Thailand, Malaysia, and Singapore, involving a total of 612 gout patients.

JW Pharmaceutical CI. JW Pharmaceutical

The main development dose of Epaminurad, 6mg, was found to have greater efficacy in lowering blood uric acid levels than the current standard treatment, febuxostat. According to the analysis of the primary efficacy endpoint — the proportion of patients achieving a serum uric acid concentration below 6mg/dL at the last three visits during the main study period — the Epaminurad 6mg group showed a treatment response rate of 50.0% (76 out of 152 patients), which was higher than the febuxostat 40mg control group (38.3%, or 59 out of 154 patients).

There was no significant difference in the incidence rate of adverse events between the two drug groups during the treatment period. The frequency of adverse drug reactions (ADRs) and serious adverse events (SAEs) was also similar, and no drug-related deaths were reported. However, the higher dose, Epaminurad 9mg, did not meet the statistical non-inferiority criteria for the primary efficacy endpoint compared to febuxostat 80mg.

Epaminurad is an oral uricosuric agent that selectively inhibits the human uric acid transporter (hURAT1), blocking the reabsorption of uric acid in the kidneys and promoting its excretion. JW Pharmaceutical is developing this substance as a new drug for patients with hyperuricemia and gout, who have abnormally elevated blood uric acid levels.

JW Pharmaceutical plans to submit a New Drug Application (NDA) for domestic approval next year. Previously, Epaminurad was selected as a pilot project for the Ministry of Food and Drug Safety's "New Drug Approval and Review Innovation Plan," and JW Pharmaceutical held two face-to-face meetings last month prior to the application process.

Eun Kyung Ham, CEO of JW Pharmaceutical, stated, "As we have demonstrated superior efficacy and safety compared to the most commonly prescribed gout treatment, febuxostat 40mg, in the domestic market, we will prepare thoroughly for the product approval process. We will focus our capabilities to ensure Epaminurad is established as a best-in-class new drug."

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