LG Chem said on Tuesday that it withdrew its global phase 3 clinical trial plan (EURELIA 1) of its gout drug candidate, LC350189 (ingredient: tigulixostat), submitted to the Spanish Agency of Medicines and Medicinal Products (AEMPS).

Gout is a type of arthritis caused by episodes of abnormal inflammation in the joints. Individuals with gout usually express high levels of urate in the blood called hyperuricemia.

LG Chem had planned to evaluate the efficacy and safety of about 350 gout patients with hyperuricemia, with three different doses of tigulixostat compared to a placebo, for six months.

According to LG Chem, the clinical trial was designed based on the European Medicines Agency (EMA) guidelines but the company withdrew its existing application because the EMA requested clinical design modifications.

The company plans to “re-apply” for the clinical trial plan through an EMA scientific advice meeting in the first half of this year, it said.

An official at LG Chem explained that as it is a global trial, it is already underway in the U.S. after FDA approval for the plan in September last year. Therefore, the clinical design cannot be easily changed and LG Chem will have to try to convince the Spanish regulator to maintain the clinical design as it is. 

Previously, LG Chem voluntarily withdrew its clinical application in China in November last year, after being asked to modify its clinical design by China's National Medical Products Administration (NMPA).