JW Pharmaceutical said Wednesday that the U.S. Drug Safety Monitoring Board (DSMB) has positively reviewed top-line results from its multinational phase 3 clinical trial of Epaminurad (codenamed URC102) for gout and recommended continuing the trial.

On Jan. 31, the DSMB, comprised of U.S. rheumatology, pharmacology, nephrology, and statistics experts, met to discuss whether to let the trial continue based on the phase 3 data.

The agency reviewed safety data from gout patients enrolled to date in the Epaminurad trial and unanimously recommended that the study continue as planned.

Following this first DSMB decision, JW Pharmaceutical plans to accelerate the phase 3 study of Epaminurad, which is being developed as a best-in-class drug in the field.

Epaminurad, which is being developed as an oral drug, is a uric acid excretion promoter that selectively inhibits hURAT1 (human uric acid transporter-1) and is a new drug candidate for hyperuricemia and gout, diseases characterized by abnormally high levels of uric acid in the blood.

The phase 3 trial of Epaminurad is evaluating the efficacy (blood uric acid reduction) and safety compared to Febuxostat in 588 gout patients in five Asian countries, including Korea.

Along with the phase 3 trial, JW Pharmaceutical also pursues global technology export (license-out). In 2019, the company licensed the development and distribution rights of Epaminurad to China’s Simcere Dongyuan Pharmaceutical to cover China, Hong Kong, and Macau.

"DSMB's recommendation to continue global clinical development of Epaminurad for the first time means that it positively evaluated the safety of clinical patients and the reliability of the data, including the drug's competitiveness," a JW Pharmaceutical official said. "We plan to accelerate the development of Epaminurad into a global gout drug that addresses unmet medical needs."