JW Pharmaceutical said Monday that it has received investigational new drug (IND) approval from the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia for a phase 3 clinical trial for its gout drug candidate, URC102 (epaminurad).

The phase 3 trial will evaluate the efficacy and safety of epaminurad compared to febuxostat in a total of 588 gout patients in five Asian countries: Korea, Taiwan, Thailand, Malaysia, and Singapore.

Gout is a metabolic disease that occurs when uric acid is not excreted through the urine.

Uric acid in the blood or synovial fluid remains in the form of crystals, deposited in the cartilage, subcutaneous tissue, and tissues around the joints, causing inflammation and pain.

Epaminurad, which is being developed as an oral drug, is a uric acid excretion promoter that selectively inhibits human uric acid transporter-1 (hURAT1).

As a new drug candidate, Epaminurad is known to be effective for hyperuricemia and gout, in which the concentration of uric acid in the blood is abnormally high.

JW Pharmaceutical confirmed the tolerability and safety of epaminurad in the Korean phase 2b clinical trial, which concluded in March 2021, meeting both the primary and secondary efficacy endpoints.

Alongside the phase 3 clinical trial of epaminurad, JW Pharmaceutical is also pursuing global license-outs. In 2019, JW Pharmaceutical signed a license-out deal with China's Simcere Pharmaceutical to develop and distribute epaminurad in China, Hong Kong, and Macau.

"With the approval of the Malaysian IND, we can now proceed with the phase 3 clinical trial of epaminurad in five Asian countries," said a JW Pharmaceutical official. "As we have confirmed the tolerability and safety in the phase 2b study, we will proceed with the phase 3 clinical trial without any delay, developing it as a best-in-class drug in the global gout treatment market, which has large unmet medical needs."