JW Pharmaceutical announced on January 15 that it has received approval from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia for a Phase 3 Investigational New Drug (IND) for Epaminurad (URC102) for the treatment of gout.
The Phase 3 clinical trial of Epaminurad will evaluate the efficacy (effectiveness in reducing blood uric acid) and safety of Epaminurad compared to Febuxostat in a total of 588 gout patients in five Asian countries, including Korea.
With this approval, JW Pharmaceutical has received approval for all of Epaminurad's multi-country Phase 3 INDs. In South Korea, the IND was approved in November 2022 and patient enrollment and dosing began last March, while in Taiwan, the IND was approved in August 2023 and the first patient was enrolled in December. This was followed by IND approvals in Thailand and Singapore in September.
Epaminurad, which is being developed as an oral agent, is a uric acid excretion enhancer that selectively inhibits hURAT1 (human uric acid transporter-1) and is a drug candidate for hyperuricemia and gout, diseases characterized by abnormally high levels of uric acid in the blood.
JW Pharmaceutical confirmed that Epaminurad was well tolerated and safe in the Korean Phase 2b clinical trial, which ended in March 2021, and met both primary and secondary efficacy endpoints.
In addition to the Phase 3 clinical trial, JW Pharmaceutical is also pursuing a global license-out of Epaminurad. In 2019, the company licensed development and commercialization rights for China, Hong Kong, and Macau to China's Shenxia Pharmaceutical.
