LG Chem, which is developing a gout treatment, has taken a step closer to global clinical trials in Europe.

LG Chem said in a public filing on Tuesday that the company has received conditional approval from the Italian regulator Agenzia Italiana del Farmaco (AIFA) for a phase 3 clinical trial (EURELIA 2) of its gout treatment candidate, tigulixostat (LC350189).

The approval came five months after LG Chem applied for the trial in August. The phase 3 study will evaluate the efficacy and safety of tigulixostat in lowering blood uric acid in patients with hyperuricemic gout. The control drug will be allopurinol, an existing gout treatment.

However, the clinical trial plan was “authorized with condition," which means that LG Chem will proceed with the clinical trial in Europe after submitting additional data. LG Chem emphasized that it is only submitting additional data and there are no changes to the clinical trial design.

LG Chem did not elaborate on the data it has been asked to provide.

The company said it hasn't been asked to provide much data, so it should be able to do so quickly. It added that given the review process by the Italian authorities, it should be able to finalize the submission within two to three months.

Tigulixostat is an oral gout treatment with a rapid onset of action and a once-daily dose, which is expected to improve patient compliance and convenience, LG Chem said. "We have submitted clinical trial plans for this treatment to the U.S. and many other countries and are conducting clinical trials. We will proceed with clinical trials in Europe upon European approval."