SK Biopharm starts phase 3 trials of epilepsy treatment
SK Biopharmaceuticals began global Phase 3 clinical trials of carisbamate, its candidate to treat symptoms of Lennox-Gastaut syndrome (LGS), the company said Thursday.
Trials will be conducted on 250 children and adults who suffer from LGS in 60 institutions in the United States and European countries.
LGS is a type of epilepsy. Patients with LGS experience many different types of seizures including tonic stiffening of the body.
There is no cure for the disorder. Around 48,000 children and adults in the United States have LGS and around 1 million worldwide.
The Pangyo, Gyeonggi-based biopharmaceutical company said carisbamate has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration. The FDA grants ODD status to drugs intended for the safe and effective treatment of rare diseases and disorders. ODD status provides certain benefits, including a seven-year period of market exclusivity if the drug is approved, as well as a tax reduction, according to the company.
SK Biopharmaceuticals aims to market the drug in 2025.
“We will endeavor to accelerate the Phase 3 clinical trials in order to market carisbamate as quickly as possible,” said Cho Jeong-woo, CEO of SK Biopharmaceuticals.
BY SARAH CHEA [firstname.lastname@example.org]