JW Pharmaceutical said on Friday that it received approval to conduct phase 3 clinical trials in Taiwan for its gout drug, epaminurad (URC102).

This marks the first time epaminurad has received approval for a phase 3 IND in a foreign country. The company has already submitted an IND to regulatory agencies in Malaysia in August, following Singapore and Thailand in July.

Previously, JW Pharmaceutical applied for phase 3 investigational new drug (IND) approval but was rejected in March by the Taiwanese regulator due to non-compliance with the control drug standard. Accordingly, the company changed the control drug items in the clinical trial design to those recognized by TFDA and reapplied in June.

Epaminurad, which is being developed as an oral drug, is a uric acid excretion promoter that inhibits uric acid transporter-1 (URAT1) and is a new drug candidate for gout, a disease caused by an abnormally high concentration of uric acid in the blood.

Gout is a metabolic disease that occurs when uric acid produced in the body is not discharged through urine and accumulates. Uric acid in the blood or joint fluid remains in the form of crystals and is deposited in cartilage, tissue around the joints, and subcutaneous tissue, causing inflammation and pain. It is caused by regular meat consumption, excessive alcohol consumption, and overeating.

Accordingly, JW Pharmaceutical will evaluate the efficacy in reducing blood uric acid and the safety of epaminurad compared to febuxostat in Taiwanese gout patients.

Epaminurad met both primary and secondary efficacy endpoints and demonstrated excellent safety and tolerability in a Korean phase 2b clinical trial that ended in March 2021 and is now recruiting patients for domestic phase 3 trials.

The company said that it is simultaneously pursuing a global technology license-out partnership. In 2019, they granted China's Simcere Pharmaceutical Group the rights to develop and sell the drug in China, Hong Kong, and Macao.

"We are happy to get phase 3 IND approval to conduct studies in Taiwan for epaminurad," said an official from JW Pharmaceutical. "We will develop epaminurad as a best-in-class drug as there is a large unmet demand in the global gout treatment market."
In Korea, the number of patients has increased from 334,705 in 2015 to 492,373 as of 2021, according to data from the Health Insurance Review and Assessment Service (HIRA). 

The global market for gout drugs, which is currently worth about 3 trillion won, is expected to reach 10 trillion won ($8.3 billion) by 2025 based on data from Grand View Research.