SK Biopharm's 'Cenobamate' Accelerates Entry into Northeast Asian Market

Clinical Efficacy Proven in Epilepsy Patients from Korea, China, and Japan

SK Biopharm announced on the 9th that it disclosed the results of a Phase 3 clinical study of Cenobamate (U.S. product name Xcopri®) in Northeast Asian patients as a poster presentation at the '2024 American Epilepsy Society' held in Los Angeles, USA, from the 6th to the 10th (local time).

SK Biopharm booth at the '2024 American Epilepsy Society' held in Los Angeles, USA, from the 6th to the 10th. Provided by SK Biopharm

Epilepsy is the third most common neurological disorder after stroke and dementia, with approximately 5 million people diagnosed worldwide each year. The recently announced Northeast Asia Phase 3 clinical trial was a multicenter, randomized, double-blind, placebo-controlled study conducted in Korea, China, and Japan targeting adult epilepsy patients aged 18 to 70 with focal seizures uncontrolled by existing antiepileptic treatments. The study evaluated the efficacy and safety of Cenobamate. Patients were randomly assigned to receive placebo or Cenobamate at doses of 100 mg, 200 mg, or 400 mg once daily as adjunctive therapy.

The study results showed that Cenobamate met the primary endpoint by demonstrating a significant median seizure reduction rate at all doses during the 6-week maintenance period when taken as adjunctive therapy. At the 400 mg dose, a median seizure reduction rate of 100% was achieved, and the company explained that a significant seizure-free rate was confirmed during the 6-week maintenance period in the secondary endpoint, the responder rate. The most common adverse reactions were dizziness and somnolence.

Cenobamate also statistically significantly reduced the frequency of partial seizures from weeks 5 to 6 of administration, showing seizure reduction effects even in the early stages of the titration period. The therapeutic effect was significant across various epilepsy subtypes, including simple partial seizures, complex partial seizures, and generalized tonic-clonic seizures.

Asian partners of Cenobamate plan to proceed with regulatory submissions in each country based on existing clinical data and these new results. Cenobamate has demonstrated a significant seizure-free rate in adult epilepsy patients suffering from unexpected seizure symptoms and recorded the number one new patient prescription share (43%) in the U.S. last year, with the recent global cumulative number of prescribed patients exceeding 140,000.

At this conference, a total of nine Cenobamate research posters were presented, including the Northeast Asian patient Phase 3 clinical trial. These included studies elucidating Cenobamate’s dual mechanism of action to confirm its differentiation from existing antiepileptic drugs, post hoc dose analyses for achieving early seizure freedom suggesting the possibility of dose optimization per patient, and studies confirming Cenobamate’s effects on epileptiform activity (EE) occurring in responsive neurostimulation (RNS).

Lee Dong-hoon, CEO of SK Biopharm, said, "Cenobamate is already recognized as an innovative and effective treatment in global markets such as the U.S. and Europe. Based on these study results, we expect to offer a new treatment paradigm to patients in Northeast Asia." He added, "We will continue to do our best to improve patients’ quality of life through the development of global innovative pharmaceuticals."

This content was produced with the assistance of AI translation services.