FDA partially halts trials of SK Biopharmaceuticals’ epilepsy drug candidate
The partial hold came after the pharmaceutical firm acknowledged that it had observed toxicity in Opakalim in a nonclinical study on rodents.
SK Biopharmaceuticals CEO Lee Dong-hoon explains the company's deal to license a new epilepsy drug candidate from U.S. biotech firm Biohaven at a press briefing held at Westin Josun Seoul in central Seoul on Aug. 26.
NEWS1
Phase 2 and 3 clinical trials in the United States of an epilepsy drug candidate from SK Biopharmaceuticals have been placed on partial hold, with enrollment of new patients temporarily suspended while dosing will continue for patients already participating in the trials.
The biopharma acknowledged on Friday that it had observed toxicity in Opakalim, or BHV-7000, in a nonclinical study in which rodents were administered a specific metabolite of the drug. The U.S. Food and Drug Administration (FDA) requested additional data to determine whether the toxicity is specific to rodents. The partial clinical hold applies to RISE 2 and RISE 3 trial phases.
SK Biopharmaceuticals reviewed the finding during due diligence before signing the licensing agreement and determined, based on opinions from outside experts and other considerations, that the toxicity is unlikely to affect human safety, according to a company statement.
Clinical trials of Opakalim have involved more than 1,200 people to date, and no adverse events directly linked to the nonclinical toxicity finding have been identified, according to the biopharma.
Patient enrollment for the RISE 3 trial has already been completed, so the schedule for announcing topline results in the second half of this year remains unchanged. Biohaven, the U.S.-based developer of Opakalim, plans to submit additional nonclinical data on the specific metabolite in consultation with the FDA and seek to have the partial clinical hold lifted.
SK Biopharmaceuticals signed a global licensing agreement with Biohaven on Aug. 26 for Opakalim and other drug candidates worth up to $795 million. The transaction has yet to close. The Korean company stated that it is in discussions with Biohaven regarding the lifting of the clinical hold and matters related to the transaction.
BY CHOI EUN-KYUNG [[email protected]]
This article was originally written in Korean and translated by a bilingual reporter with the help of generative AI tools. It was then edited by a native English-speaking editor. All AI-assisted translations are reviewed and refined by our newsroom.
