JW Jungwoo Pharmaceutical "Safety of Gout Treatment 'Epaminurad' Confirmed in Patients with Renal Impairment"

JW Choongwae Pharmaceutical headquarters building. [Photo by JW Choongwae Pharmaceutical]

[Asia Economy Reporter Lee Gwan-joo] JW Pharmaceutical announced on the 19th that it has confirmed the safety of the gout treatment drug 'Epaminurad (URC102)' in a Phase 1 clinical trial involving patients with renal impairment.

Epaminurad, being developed as an oral drug, is a uric acid excretion promoter that inhibits URAT1 (uric acid transporter-1). It is a new drug candidate effective for gout caused by hyperuricemia, a condition characterized by abnormally high uric acid levels in the blood.

JW Pharmaceutical conducted an additional Phase 1 clinical trial from December last year to this month to expand the indications and dosing methods of Epaminurad, involving 15 patients with renal impairment and 12 healthy adults.

According to the final report of this Phase 1 clinical trial, both patients with moderate renal impairment and healthy adults showed excellent tolerability and safety, with no significant differences in safety, pharmacokinetic, or pharmacodynamic characteristics between the two dosing groups. Additionally, no differences in safety, pharmacokinetics, or pharmacodynamics were observed in healthy adults regardless of food intake.

Based on these clinical results, JW Pharmaceutical plans to conduct a global Phase 3 clinical trial to develop Epaminurad as a global gout drug combining efficacy and safety. The Phase 3 trial will involve a total of 588 gout patients in Korea, Taiwan, and European countries. On the 24th of last month, the Ministry of Food and Drug Safety approved the multinational clinical trial plan (IND). The clinical trial plan was submitted to the Taiwan Food and Drug Administration (TFDA) on the 16th of this month, and the IND will be submitted to European regulatory authorities in the first half of next year.

A JW Pharmaceutical official stated, "This clinical trial confirmed that Epaminurad can be administered to patients with moderate renal impairment at the same dosage and method as in healthy adults, and that it offers dosing convenience regardless of before or after meals." He added, "We will develop Epaminurad as the best-in-class new drug in the gout treatment market, where unmet medical needs are very high."

Meanwhile, JW Pharmaceutical licensed the development and sales rights of Epaminurad in the Chinese market (including Hong Kong and Macau) to Simcere Pharmaceutical in China in 2019, and is currently pursuing global technology transfers excluding China.

This content was produced with the assistance of AI translation services.