JW Pharmaceutical’s gout drug safe in nephropathy patients

JW Pharmaceutical said Monday that epaminurad (pipeline name: URC102), a gout treatment, proved its safety in nephropathy patients in a phase 1 trial.

Epaminurad, an oral medicine, is a uricosuric that restrains URAT1(uric acid transporter-1), according to the company. It is believed to be effective in gout disease caused by hyperuricemia.

JW Pharmaceutical conducted the additional phase 1 trial between December 2021 to December 2022 to expand indications and administration methods of epaminurad. Fifteen nephropathy patients and 12 healthy adults participated in the trial. 

The results showed that epaminurad showed good drug tolerance and safety in both moderate nephropathy patients and healthy adults. There was no significant difference between the two groups regarding pharmacokinetics and pharmacodynamics.

Also, there was no difference in safety, pharmacokinetics, and pharmacodynamics related to food intake in healthy adults.

JW Pharmaceutical plans to conduct a global phase 3 trial study targeting targets 588 gout patients in Korea, Taiwan, and Europe, as it received the nod for the global study from the Ministry of Food and Drug Safety on Nov. 24.