JW Pharma to conduct Phase 3 trials in Thailand for gout treatment

South Korea's JW Pharmaceutical Corp. on Thursday said it received approval from Thailand's Food and Drug Administration to conduct Phase 3 clinical trials for the company's gout candidate drug Epaminurad (URC102).

This is the second international approval for such testing after Taiwan last month. JW Pharmaceutical has applied in five Asian countries to conduct Phase 3 trials for Epaminurad on a combined 588 gout patients, getting authorization so far from South Korea, Taiwan and Thailand.

The company in March began patient registration and administration of Epaminurad in South Korea and applied for clinical trials in Singapore in July and Malaysia last month.

With Thailand giving the green light for the trials, JW Pharmaceutical will evaluate through tests on gout patients there the safety and effectiveness of Epaminurad in reducing uric acid in blood.

Promoting the excretion of uric acid by inhibiting uric acid transporter-1, or URAT1, Epaminurad is being developed as an orally administered drug for gout caused by hyperuricemia, a condition in which blood has an abnormally high concentration of uric acid.

Through domestic Phase 2b trials that ended in March 2021, JW Pharmaceutical confirmed Epaminurad's high levels of tolerance and safety and the drug candidate met both primary and secondary endpoints.

The company is also pursuing global technology exports through the licensing out method. In 2019, it transferred the development and sales rights for Epaminurad for Hong Kong and Macao to Simcere Pharmaceutical of China.

"The Phase 3 protocol of our self-designed Epaminurad meets the clinical testing standards of overseas health authorities," a JW Pharmaceutical source said. "We will smoothly conduct multi-country Phase 3 trials and develop it as the best-in-class new drug on the global market for gout treatment."

Write to Ye-Na Kim at yena@hankyung.com