[Photo provided by LG Chem]
Expectations are growing that South Korea’s major pharmaceutical companies JW Pharmaceutical and LG Chem would be a next blockbuster drug producer in gout treatment as they are cleared for global phase 3 clinical trials of their respective novel gout medicines.
JW Pharmaceutical announced last week that Korea’s Ministry of Food and Drug Safety (MFDS) approved a multinational phase 3 clinical trial of epaminurad (URC102), an investigational oral uric acid transporter-1 (URAT1) inhibitor. URAT1 is known to play an important role in regulating blood uric acid levels. In early clinical trials, epaminurad demonstrated significant efficacy in the treatment of gout disease caused by abnormally high serum uric acid.
The phase 3 trial is designed to evaluate the efficacy and safety of epaminurad versus febuxostat, a xanthine oxidase inhibitor, in 588 gout patients in Korea, Taiwan, and Europe. The company said it will submit a phase 3 protocol to Taiwan next month and to European health authorities in the first half of next year.
LG Chem also received a nod for its planned phase 3 trial of tigulixostat (LC350189) from the U.S. Food and Drug Administration (FDA) on Nov. 11. The investigational gout medicine has a mechanism of inhibiting uric acid levels in the blood unlike epaminorad, which promotes uric acid excretion.
LG Chem plans to conduct the clinical trial for 12 months to evaluate the efficacy and safety of tigulixostat versus allopurinol in 2,600 patients in the U.S. and Europe.
JW Pharmaceutical shares were down 2.26 percent at 19,450 won ($14.54) on Monday morning, while LG Chem shares were up 0.83 percent at 717,000 won.
By Shin Yoo-kyung and Minu Kim
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]