SK Biopharm has applied for a new global clinical trial plan of its epilepsy drug Xcopri (ingredient: cenobamate) to expand the treatment of pediatric patients.

According to the U.S. National Institutes of Health, SK Biopharm submitted a new global phase 3 clinical trial plan of Xcopri. The study seeks to check the safety and drug tolerance in patients aged 2-17. The company plans to recruit 140 patients and divide them into four age groups to evaluate the therapeutic effect and pharmacokinetic properties of Xcopri.

The researchers have set the number of adverse events as the primary endpoint in the clinical trials and measure the area under the plasma level-time curve. In addition, they plan to conduct a five-point hedonic scale evaluation used to measure product preference on the first and 15th days of clinical trials.

SK Biopharm will begin recruiting participants next month and complete all related procedures, including data collection, by September 2024.

The U.S. Epilepsy and Sleep Center has confirmed its clinical participation.

The Korean company has tried to enhance the value of new drugs by expanding indications of Xcopri even after the commercialization.

In 2018, SK Biopharm started a phase 3 clinical trial to add an indication for primary generalized tonic-clonic seizure, and the study is still ongoing. It also began a phase 3 multinational study including Asian patients.

In the second half of this year, the company started to target the European market in partnership with Angelini Pharma, marketing the drug as Ontozry in Germany. With its marketing partners, SK Biopharm said the company would accelerate its advance to the global market.