JW Pharmaceutical is experiencing a surge of over 15% in its stock price following the announcement of positive results from a multinational Phase 3 clinical trial for its gout treatment candidate.
As of 1:07 PM on August 12, the Korea Exchange reported that JW Pharmaceutical's shares rose by 4,100 won (15.62%) to 30,350 won. At one point during the trading session, the stock reached 31,650 won.
On the previous day, JW Pharmaceutical confirmed the efficacy of its gout treatment candidate, efapiminurad, at the primary development dose of 6 mg in the Phase 3 trial. The company plans to submit a New Drug Application (NDA) aiming for domestic approval in 2027.
The trial involved 612 gout patients across 52 institutions in five Asian countries and regions, including South Korea, Taiwan, Thailand, Malaysia, and Singapore. The treatment response rate for the 6 mg efapiminurad group was 50.0%, surpassing the 38.3% response rate of the standard treatment group receiving 40 mg febuxostat.
Efapiminurad is an oral gout treatment candidate that selectively inhibits the human urate transporter 1 (hURAT1), reducing uric acid reabsorption in the kidneys and promoting its excretion.
However, the 9 mg dosing group did not meet the statistical non-inferiority criteria compared to the 80 mg febuxostat group for the primary efficacy endpoint.
Based on the clinical results, JW Pharmaceutical will further review the direction for pursuing high-dose approvals.
* This article has been translated by AI.
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