LG Chem Submits Second Clinical Trial Application for Gout Drug Phase 3 to US FDA

Comparative Evaluation of Efficacy and Safety of Existing Yakgwa
Including Previously Applied Placebo-Controlled Trials
Recruitment of 3,000 Patients Across Multiple Countries

[Asia Economy Reporter Lee Gwanju] LG Chem announced on the 1st that it has submitted a plan for the second Phase 3 clinical trial of its self-developed gout drug 'Tigulixostat' to the U.S. Food and Drug Administration (FDA). Previously, LG Chem had applied to the FDA for a placebo-controlled trial plan.

This clinical trial will use 'Allopurinol,' the first-line treatment ingredient for gout, as the control group, and plans to evaluate the long-term safety and efficacy of 12 months of administration in 2,600 adult gout patients with hyperuricemia in the U.S., Europe, and other regions. Including the number of patients recruited for the previously applied placebo-controlled trial plan, a total of about 3,000 patients will participate in the final clinical stage of Tigulixostat.

The primary efficacy endpoint of this trial is set as the proportion of patients whose serum uric acid levels measured at months 4, 5, and 6 of administration are all below 6 mg/dL. Secondary endpoints include the proportion of patients whose serum uric acid levels measured at months 4, 5, and 6 are all below 5 mg/dL, the proportion of patients who experienced one or more gout attacks from month 6 to month 12, and the proportion of patients whose gout nodules were completely resolved by the 12-month point.

LG Chem stated, “Based on differentiated clinical results, we will secure the status of first-line treatment and enhance our global business competitiveness.”

Tigulixostat is a drug that inhibits the expression of the uric acid-producing enzyme 'xanthine oxidase (XO).' LG Chem confirmed the possibility of developing a differentiated new drug from existing treatments based on the rapid and strong uric acid-lowering effect in Phase 2 clinical trials and demonstrated safety levels similar to those of the placebo group.

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