[Asia Economy Reporter Lee Gwan-joo] JW Pharmaceutical announced on the 25th that it has received approval from the Ministry of Food and Drug Safety for the multinational Phase 3 clinical trial plan (IND) of the gout treatment Epaminurad (code name URC102).
Epaminurad, being developed as an oral drug, is a uric acid excretion promoter that inhibits URAT1 (uric acid transporter-1). It is a new drug candidate effective for gout caused by hyperuricemia, a condition characterized by abnormally high uric acid levels in the blood.
Following this approval, JW Pharmaceutical will evaluate the efficacy (reduction of blood uric acid levels) and safety of Epaminurad compared to febuxostat in a total of 588 gout patients in Korea, Taiwan, and European countries. Clinical trial plans will be submitted to regulatory authorities in Taiwan and Europe in December this year and the first half of next year, respectively.
In the domestic Phase 2b clinical trial of Epaminurad, which ended in March last year, both primary and secondary efficacy endpoints were met, and high safety and tolerability were confirmed. JW Pharmaceutical plans to develop Epaminurad as a global gout drug combining efficacy and safety.
The company explained that this multinational Phase 3 trial was designed with consideration for overseas marketing authorization through global technology licensing in the future. A JW Pharmaceutical official said, "As the incidence of gout is increasing, there is a significant unmet need for effective and safe gout treatments. We plan to proceed with the Phase 3 clinical trial without delay to supply Epaminurad to gout patients worldwide and explore various opportunities for global expansion."
JW Pharmaceutical licensed the development and sales rights of Epaminurad for the Chinese market (including Hong Kong and Macau) to Simcere Pharmaceutical in China in 2019 and is currently pursuing global technology transfers excluding China.
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