SK Biopharm has applied for a new global clinical trial plan for its epilepsy drug Xcopri (ingredient: cenobamate) to expand the treatment of pediatric patients.
According to the United States National Institutes of Health, SK Biopharm has submitted a new global Phase 3 clinical trial plan for Xcopri. The study aims to verify the safety and tolerance of the drug in patients aged 2 to 17 years. The company plans to recruit 140 patients and divide them into four age groups to assess the therapeutic effect and pharmacokinetics of Xcopri.
The researchers defined the number of adverse events as the primary endpoint in clinical trials and measured the area under the plasma level-time curve. In addition, they plan to conduct an assessment on the five-point hedonic scale used to measure product preference during the first and 15th days of clinical trials.
SK Biopharm will start recruiting participants next month and complete all related procedures, including data collection, by September 2024.
The US Epilepsy and Sleep Center has confirmed its clinical participation.
The Korean company has tried to increase the value of new drugs by expanding the indications for Xcopri even after marketing.
In 2018, SK Biopharm launched a Phase 3 clinical trial to add an indication for primary generalized tonic-clonic seizure, and the study is still ongoing. He has also started a multinational phase 3 study including Asian patients.
In the second half of this year, the company began targeting the European market in partnership with Angelini Pharma, marketing the drug under the name Ontozry in Germany. Together with its marketing partners, SK Biopharm said the company will accelerate its lead in the global market.