SK Biopharmaceuticals said it would begin to develop a second new drug for epilepsy to solidify its status in the epilepsy treatment market and specialize in central nervous system diseases.
The company said Tuesday the U.S. Food and Drug Administration gave the green light for investigational new drug (IND) application for SKL24721, a drug candidate for epilepsy treatment.
The company will conduct a phase-1 trial through its U.S. subsidiary, SK Life Science, from 2020. The study will evaluate the safety, tolerability, and pharmacokinetics of SKL24741 in healthy adults. In pre-clinical studies, SKL24741 showed efficacy in various animal models.
On Nov. 21, SK Biopharm received FDA approval for Xcopri (ingredient: cenobamate), a treatment for partial-onset seizures in adults.
SKL24721 might work for patients who do not respond to Xcopri. Epilepsy is a disease in which a seizure repeatedly occurs because nerve cells in a specific area of the brain are stimulated. As there are numerous causes of seizures, patients have many different reactions to the same treatment. More than 20 antiepileptic drugs have arrived in the market, but demand for new drugs continues to grow.
When granting the nod for Xcopri, the FDA said, “Patients can have different responses to the various seizure medicines that are available. This approval provides an additional needed treatment option for people with this condition.”
By working on a new drug, SK Biopharm aims to secure expertise in the epilepsy treatment market and expand its market share.
“To treat epilepsy, it is difficult to apply a single drug to patients uniformly. So, it is best to provide as many treatment options as possible. Leading players in this field also have two or three drugs,” an official at SK Biopharm said.
Based on the experience of getting approval for Xcopri, the company is expected to develop SKL24721 separately.
The company also plans to expand the indication for Xcopri, conducting a global phase-3 trial on the drug in patients with generalized seizures.
According to the latest statistics by the U.S. Centers for Disease Control and Prevention (CDC), about 20,000 people are newly diagnosed with epilepsy a yea. About 60 percent of patients with epilepsy continue to suffer from seizures even after taking antiepileptic drugs.