JW Pharmaceutical said on the 11th that it plans to apply for domestic marketing approval after confirming efficacy in a multinational phase 3 clinical trial of its gout treatment candidate "efaminurad."
The trial was conducted with 612 gout patients at 52 institutions across five countries and regions in Asia, including Korea, Taiwan, Thailand, Malaysia and Singapore. For the 6 mg dose, the main development strength of efaminurad, the reduction of blood uric acid was superior to the existing standard therapy "febuxostat."
An analysis of the primary efficacy endpoint, "the proportion of patients achieving a serum uric acid concentration below 6 mg/dL at the last three visits of the main study period," showed that the efaminurad 6 mg group recorded 50.0% (76 of 152), a higher treatment response rate than the febuxostat 40 mg control group (38.3%, 59 of 154).
During the treatment period, the incidence of adverse events did not differ significantly between the two treatment groups. Adverse drug reactions (ADR) and serious adverse events (SAE) were at similar levels, and there were no drug-related deaths.
However, for the higher 9 mg dose of efaminurad, it was reported that the primary efficacy endpoint did not meet the statistical noninferiority criterion compared with 80 mg of febuxostat.
Efaminurad is an oral uricosuric that selectively inhibits the human urate transporter (hURAT1), suppressing renal reabsorption of uric acid and promoting its excretion.
JW Pharmaceutical is developing this compound as a new drug for patients with hyperuricemia, in which blood uric acid levels are abnormally high, and gout. JW Pharmaceutical plans to submit a new drug application (NDA) for domestic marketing approval next year.