SK Biopharmaceuticals is on track to conduct phase 3 clinical trials of its novel epilepsy treatment cenobamate in Korea, China and Japan.

The company announced Thursday that its phase 3 clinical trial design was approved by Korean drug authorities Wednesday, to be carried out at Seoul National University Hospital.

In China, it is awaiting approval from the National Medical Products Administration, after having made the application in June. In Japan, the company is readying the application to the Pharmaceuticals and Medical Devices Agency in October.

SK Biopharmaceuticals anticipates more than 500 patients from China, Japan and Korea will enroll in the phase 3 trials that are intended to evaluate the efficacy and safety of cenobamate as an adjunctive therapy.

“The initiation of the phase 3 clinical trial in Asia is a major milestone for cenobamate in our continuous effort to address unmet needs in epilepsy and central nervous system disorders worldwide,” said Park Jung-shin, vice president of SK Biopharmaceuticals’ drug development business.

“SK Biopharmaceuticals has been planning to enter the Asian market. … We are pleased to move forward as intended to expand our global footprint,” said Park.

Cenobamate gained the US Food and Drug Administration’s approval in November 2019 as a novel treatment alternative for partial onset seizure patients who have grown tolerant to existing therapies.

In the US, cenobamate is distributed under the name Xcopri by SK Life Science. In Europe, the drug is to be marketed under another name by Arvelle Therapeutics -- a company founded in 2019 by CEO Mark Altemeyer specifically to in-license the commercial rights to the drug.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)