LG Chem announced on December 19 that it has received conditional approval from the European Medicines Agency (EMA) for its global Phase 3 Investigational New Drug Application (IND) for Tigulixostat (LC350189) for the treatment of gout.
The Phase 3 study will evaluate the efficacy and safety of tigulixostat in raising blood uric acid in patients with hyperuricemic gout. The study is expected to enroll approximately 2,600 patients globally and will be randomized, double-blind, active and placebo-controlled.
The 12-month treatment period will evaluate the efficacy of tigulixostat in lowering blood uric acid, the incidence of gout flares, the reduction of gout nodules (tophi), and safety compared to the active control, allopurinol, in the treatment of gout.
The approval of the IND is conditional and subject to the submission of additional data on tigulixostat.
"We plan to proceed with the clinical trial in Europe after submitting the documents without any changes to the clinical trial plan and design," said an official from LG Chem. "Through this trial, we will prove the efficacy and safety of Tigulixostat as a treatment for gout."
