SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders, submitted a clinical study protocol to the U.S. Food and Drug Administration (FDA) 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). Carisbamate has received orphan drug designation from the FDA for the potential treatment of LGS.
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.
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“The initiation of the Phase 3 trial evaluating carisbamate in Lennox-Gastaut syndrome marks a new chapter for SK life science in developing therapies to treat central nervous system disorders in adult and pediatric patients,” said Marc Kamin, MD, chief medical officer at SK life science. “We are committed to applying our expertise in epilepsy to develop new therapy options for LGS, a condition with high unmet medical need.”
“Our aim is to provide effective treatment options for people with central nervous system disorders,” said Jeong Woo Cho, PhD, 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.”