The US Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application for SKL24741 (SK LIfe Sciences, Parmus, NJ), for the treatment of epilepsy and central nervous system (CNS) disorders. SA phase 1 clinical trial for SKL24741 is expected to begin in 2020.
Although the exact mechanism of action is not fully understood, the antiepileptic effects of SKL24741 may result from its ability to reduce excitatory nerve activity by inhibiting voltage-gated sodium channels to slow or stop seizures. A range of in vitro studies have suggested that SKL24741 has a higher affinity for the inactivated form of these sodium channels, potentially allowing selective targeting of the pathologic conditions of epilepsy.
The IND acceptance of SKL24741 adds to the momentum of SK Biopharmaceuticals' and SK life science's growing pipeline of 8 CNS compounds, which target conditions such as epilepsy, Lennox-Gastaut syndrome, attention-deficit/hyperactivity disorder (ADHD), and bipolar disorder. It also adds to the company's potential therapeutic offerings in epilepsy.
"There are 3.4 million people in the US living with epilepsy, and approximately 60% of adults with the disorder report that they continue to have seizures, even if they take medication. There is a clear need for new treatment options that can help to change this reality," said Marc Kamin, MD, chief medical officer, SK life science. "The FDA's acceptance of the IND for SKL24741 is another step forward in our work to discover and develop new therapies for people with epilepsy, and it showcases our continued commitment to innovation in the CNS category."
Claire Smyth, BSc; David Roberts, BSc; and Kenneth Monaghan, PhD
Michael S. Cartwright, MD, MS, and Hwajin Lee, MD