SK Biopharm Enters Phase 3 Clinical Trial for 'Carisbamate', a New Drug for Intractable Pediatric Epilepsy

SK Biopharm CI (Photo by SK Biopharm)

[Asia Economy Reporter Chunhee Lee] SK Biopharm's Lennox-Gastaut syndrome treatment 'Carisbamate' is starting global Phase 3 clinical trials.

SK Biopharm announced on the 6th that the Phase 3 clinical trial of Carisbamate will be conducted at over 60 institutions in the US, Europe, and other regions, targeting approximately 250 pediatric and adult patients with Lennox-Gastaut syndrome. The study will be randomized, double-blind, and placebo-controlled to evaluate the drug's efficacy, safety, and tolerability.

Lennox-Gastaut syndrome is a rare, intractable pediatric epilepsy characterized by multiple types of seizure symptoms. It is also known to be accompanied by developmental and behavioral disorders. There is no cure, and the treatment prognosis is poor, with about 85% of patients continuing to experience seizures into adulthood. Approximately 48,000 people suffer from this disease in the US alone, and it is estimated that about 1 million patients exist worldwide.

SK Biopharm is placing high hopes on Carisbamate's broad seizure control effects and safety in administration. It aims to launch it in the global market by 2025 as the next-generation neurodrug following the epilepsy treatment 'Cenobamate' and the sleep disorder treatment 'Solriamfetol.'

Carisbamate was designated as an 'Orphan Drug' by the US Food and Drug Administration (FDA) in 2017. Accordingly, it receives various benefits such as priority review application rights, tax reductions, and exemption from application fees. Upon successful completion of Phase 3 and approval, a seven-year market exclusivity period will be granted.

Jungwoo Cho, CEO of SK Biopharm, said, “We will accelerate the Phase 3 clinical trials for the rapid commercialization of Carisbamate,” adding, “We will focus on developing new treatment options to dramatically improve the quality of life for patients suffering from the disease.”