JW Pharmaceutical (JW) announced on the 21st that it received approval for a phase 3 clinical trial (IND) for the arthrifuge ‘Epaminurad (code name URC102)’ from the Thai FDA on the 18th.
Epaminurad has received IND approval for phase 3 clinical trials overseas, and This is the second time following Taiwan last month. JW applied for an IND in five Asian countries, including Korea, to conduct Phase 3 clinical trials of Epaminurad on 588 gout patients. Epaminurad has received IND approval in Korea, Taiwan, and Thailand, and JW applied for IND to Singapore and Malaysian health authorities in July and August, respectively. In Korea, patient registration and medication administration began in March.
With this IND approval, JW can evaluate the effectiveness (effect of reducing blood uric acid) and safety of Epaminurad in Thai gout patients.
Epaminurad, which is being developed as an oral medication, is a uric acid excretion promoter that inhibits URAT1 (uric acid transporter-1) and is a new drug candidate effective in treating gout disease with abnormally high uric acid concentration in the blood.
JW confirmed the excellent tolerability and safety of Epaminurad in a domestic clinical trial that ended in March 2021. Epaminurad also met the criteria for primary and secondary efficacy assessments.
JW is also pursuing global technology export (license-out) along with the phase 3 clinical trial of Efaminurad. JW exported the technology to China’s Simseeo Pharmaceutical for development and distribution rights for China, Hong Kong, and Macau in 2019.
A JW official said, “Epaminurad’s self-designed Phase 3 clinical protocol is meeting the clinical conduct standards of overseas health authorities one after another,” and “JW conducted the multi-country Phase 3 clinical trial without a hitch, making it the best new drug in the global gout treatment market. JW will develop it as a best-in-class.”
By_BK Min, KDFN kdf@kdfnews.
The summary of this article in Korean is as follows.
■JW중외제약 "통풍치료제 ‘에파미뉴라드’, 태국 임상 3상 승인"
JW중외제약은 지난 18일 태국 식품의약청으로부터 통풍치료제 ‘에파미뉴라드(코드명 URC102)’에 대한 임상 3상 시험계획(IND)을 승인받았다고 21일 밝혔다.
에파미뉴라드가 해외에서 임상 3상 IND를 승인받은 것은 지난달 대만에 이어 두 번째다. 지난 7월과 8월에는 싱가포르와 말레이시아 보건당국에 IND를 신청했다. 국내에서는 지난 3월부터 환자 등록 및 투약을 시작했다.
경구제로 개발하고 있는 에파미뉴라드는 URAT1(uric acid transporter-1)을 억제하는 기전의 요산 배설 촉진제로 고요산혈증으로 인한 통풍질환에 대한 신약후보물질이다. 지난 2021년 3월 종료된 국내 임상 2b상에서 내약성과 안전성이 확인됐다.
JW중외제약 관계자는 “다국가 임상 3상을 차질 없이 진행해 글로벌 통풍치료제 시장에서 계열 내 최고 신약으로 개발하겠다”고 말했다.
박주범 기자 email@example.com