JW Pharmaceutical announced on Jan. 15 that it has received approval from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for a phase 3 clinical trial plan, or investigational new drug (IND), of its gout treatment drug Epaminurad (code name URC102).
The Phase 3 clinical trial for Epaminurad will assess efficacy, specifically the reduction in serum uric acid levels compared to febuxostat, and safety in a total of 588 gout patients across five Asian countries, including South Korea.
With this approval, JW Pharmaceutical has now obtained all approval for the multinational Phase 3 IND of Epaminurad. In South Korea, patient registration and administration began in March last year after receiving IND approval in November 2022. In Taiwan, the first patient registration was completed in December after IND approval in August 2023. Subsequently, IND approvals were obtained in Thailand and Singapore in September.
Epaminurad, which is under development as an oral medication, is a novel drug candidate that selectively inhibits the urate transporter, human uric acid transporter-1 (hURAT1), to promote urate excretion. It is effective for hyperuricemia and gout conditions characterized by abnormally high levels of uric acid in the blood.
In the domestic Phase 2b clinical trial, which was concluded in March 2021, JW Pharmaceutical confirmed the excellent tolerability and safety of Epaminurad. Additionally, it met the criteria for both primary and secondary efficacy evaluation variables.
JW Pharmaceutical is not only progressing with the Phase 3 clinical trial of Epaminurad but also actively pursuing global technology export, or license-out. In 2019, the company exported development and licensing rights for China, Hong Kong, and Macau to Nanjing Simcere Dongyuan Pharmaceutical in China.