SK Biopharm, Positive Results from Phase 3 Clinical Trial of 'Cenobamate'

[Financial News] SK Biopharm announced on the 16th that it has secured positive topline results from a Phase 3 clinical trial for generalized seizure epilepsy in adolescents and adults, conducted to expand the new indication for the epilepsy drug 'Cenobamate'.
In this trial, the efficacy and safety of Cenobamate compared to placebo were evaluated in 169 patients aged 12 years and older with primary generalized tonic-clonic seizures (PGTC) across 122 clinical trial sites in 12 countries including the United States and Korea.
The clinical results showed that during the double-blind treatment period, the PGTC seizure frequency change rate decreased by 71.9% in the Cenobamate group compared to baseline, while the placebo group saw a 39.6% reduction. A statistically significant reduction effect (p=0.003) was confirmed in the primary evaluation index.
In the safety evaluation, the most common adverse reactions occurred in 60% of the Cenobamate group and 53% of the placebo group. Most of the reported adverse cases were mild to moderate, confirming overall safety and tolerability.
SK Biopharm plans to present detailed clinical results at the American Epilepsy Society (AES) in December.
Cenobamate is currently approved and prescribed for adult partial-onset seizure patients. Based on these clinical results, it is expected that the indication can be expanded to include adolescent and adult primary generalized tonic-clonic seizure patient groups. SK Biopharm plans to proceed with the sNDA process for the addition of the PGTC indication with the U.S. Food and Drug Administration (FDA).
Lee Dong-hoon, CEO of SK Biopharm, said, "The broad efficacy of Cenobamate has been proven clinically," adding, "Cenobamate's position in the global anticonvulsant market will be significantly strengthened."


kaya@fnnews.com Choi Hye-rim Reporter