SK Life Science Steps Forward in Treating Seizure Disorders

SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., submitted a clinical study protocol to the U.S. Food and Drug Administration (FDA) on January 6th. The clinical study protocol was for a Phase 3 clinical trial to evaluate the efficacy and safety of carisbamate for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).

LGS and Orphan Drug Designation for Carisbamate

SK Life Science is focused on developing treatments for central nervous system (CNS) disorders and has sought to provide solutions for less common forms of epilepsy. 

LGS is a relatively rare disease with a total of between 1-2 million cases globally and accounting for only 5% of total childhood epilepsy cases. This disorder is marked by multiple types of seizures and often coupled with developmental and behavioral disorders. 

LGS is often unresponsive to treatment, and over 85% of children with LGS will continue to have seizures into adulthood. This low level of occurrence is the reason for Carisbamate receiving the orphan drug designation from the FDA. 

While how exactly carisbamate exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents.

 Effective Treatment Options for Central Nervous System Disorders 

“Our aim is to provide effective treatment options for people with central nervous system disorders,” said Jeong Woo Cho, President and CEO of SK Biopharmaceuticals and SK Life Science. “Moving carisbamate into Phase 3 development reaffirms our commitment to expanding our CNS pipeline and realizing this important goal.” 

The Phase 3, global, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy of two doses of carisbamate in more than 250 patients aged 4-55. Assuming all goes well SK Life Science and its parent company, SK Biopharmaceuticals could benefit from the promise of new products and the positive regard from developing an orphan drug. 

Both SK Biopharmaceuticals and SK life science are part of SK Group, one of the largest conglomerates in Korea. SK Inc. continues to enhance its portfolio value by executing long-term investments. SK Life Sciences is a privately held, medium-sized firm based out of New Jersey. This company has been able to successfully get both Cenobamate and Solriamfetol approved by the FDA and EMA along with conducting their various clinical trials.

Author

Eduardo Longoria