SK Biopharm’s New Epilepsy Drug Candidate Receives Partial Clinical Hold from U.S. FDA

FDA Requests Additional Evidence on Nonclinical Toxicity Findings
New Patient Enrollment Temporarily Suspended... RISE3 Timeline Unchanged

The phase 2/3 clinical trials in the United States for "OpaKalim (BHV-7000)," a new epilepsy drug candidate being developed by SK Biopharm, have received a Partial Clinical Hold from the U.S. Food and Drug Administration (FDA).

On the 10th, SK Biopharm disclosed that its partner company, Biohaven, had been notified by the FDA of a Partial Clinical Hold on the RISE2 and RISE3 phase 2/3 clinical trials of OpaKalim for patients with refractory focal onset seizures. The FDA requested additional data to determine whether the toxicity observed in nonclinical toxicity tests—where certain metabolites of OpaKalim were administered to rodents—is a "species-specific" phenomenon limited to rodents.

Lee Donghun, CEO of SK Biopharmaceuticals, is giving a presentation at a press briefing on the 26th of last month. SK Biopharmaceuticals

Under the Partial Clinical Hold, current patients receiving treatment may continue, but new patient enrollment will be suspended until the additional nonclinical studies are completed. However, according to the company, the RISE3 trial has already completed patient enrollment and randomization, so this hold will not impact that study. The company also stated that the planned topline results announcement for RISE3 in the second half of this year is currently unchanged.

SK Biopharm explained that it had reviewed the relevant nonclinical toxicity findings during due diligence prior to signing the contract, and, based on external expert reviews and other factors, determined the likelihood of a direct correlation to human safety is limited. The company added that, to date, no adverse events directly linked to this toxicity finding have been identified in clinical trials involving more than 1,200 subjects.

Biohaven plans to conduct additional nonclinical studies and submit the relevant data to the FDA to seek removal of the Partial Clinical Hold. Whether and when it will be lifted will depend on the FDA's review of the additional data.

This content was produced with the assistance of AI translation services.