SK Biopharmaceuticals announced on the 16th that it has obtained the top-line results of a Phase 3 clinical trial conducted for the expansion of indications for its innovative epilepsy drug, Cenobamate (U.S. product name Xcopri), targeting generalized tonic-clonic seizures in adolescents and adults.

Currently, Cenobamate is only prescribed for the treatment of adult partial-onset seizure patients. This Phase 3 trial was conducted at 122 clinical trial sites in 12 countries, including the United States and South Korea, involving 169 patients aged 12 and older with primary generalized tonic-clonic seizures (PGTC Seizure). The trial focused on evaluating efficacy and safety compared to a placebo.

The clinical results showed that during the double-blind treatment period, the frequency of PGTC seizures 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 was confirmed in the primary endpoint. In terms of safety evaluation, the most common treatment-emergent adverse events (TEAEs) occurred in 60% of the Cenobamate group and 53% of the placebo group. Most adverse events were mild to moderate, confirming the overall safety and tolerability of Cenobamate, according to SK Biopharmaceuticals. The detailed results of this clinical trial will be presented at the American Epilepsy Society (AES) meeting in December.

PGTC seizures are known as a representative type of generalized seizure and are a serious form of seizure that increases the risk of seizure-related injuries and sudden unexpected death in epilepsy (SUDEP). However, due to limited treatment options, SK Biopharmaceuticals expects that these clinical results could contribute to addressing unmet needs.

Based on these results, the company plans to pursue approval from the U.S. Food and Drug Administration (FDA) for the addition of new indications.

Lee Dong-hoon, CEO of SK Biopharmaceuticals, stated, "Since its launch, Cenobamate has established itself as an innovative drug in the global market," adding, "This clinical result clinically proves the broad efficacy of Cenobamate, and we expect its global market position to be significantly strengthened in the future." He further stated, "We will do our best to provide new treatment opportunities to more patients."

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