The U.S. Phase 2/3 clinical trials of SK Biopharmaceuticals’ epilepsy drug candidate “Opocalim (BHV-7000),” which the company is seeking to in-license, have been placed under a Partial Clinical Hold by the U.S. Food and Drug Administration (FDA).

SK Biopharmaceuticals announced on the 10th that its partner Biohaven had received notice from the FDA that Opocalim’s Phase 2/3 RISE2 and RISE3 trials were subject to a Partial Clinical Hold.

This action stems from toxicity observed in a non-clinical study in which a specific metabolite of Opocalim was administered to rats. The FDA has requested additional data to determine whether the toxicity could also occur in humans or is limited to rodents.

Patients currently receiving treatment may continue, but enrollment of new patients is suspended. According to the company, the impact of this measure is limited because patient enrollment and randomization for the RISE3 trial have already been completed. SK Biopharmaceuticals is maintaining its existing schedule for announcing RISE3 topline results in the second half of 2026.

On August 26, SK Biopharmaceuticals signed a technology in-licensing agreement with Biohaven covering Kv7 potassium channel activators, including Opocalim. However, the final closing procedures following the contract signing have not yet been completed.

SK Biopharmaceuticals stated that this non-clinical toxicity finding had already been reviewed during pre-contract due diligence and that, based on opinions from external experts, it assessed that the phenomenon was likely limited to rodents.

Opocalim has so far been tested in clinical trials involving more than 1,200 subjects. SK Biopharmaceuticals said that, in the clinical data obtained to date, no adverse events directly related to this toxicity finding have been identified.

Biohaven plans to prepare and submit the additional data requested by the FDA and to seek lifting of the Partial Clinical Hold. SK Biopharmaceuticals added that it is reviewing the related matters with Biohaven and discussing issues concerning the transaction closing in parallel.

SK Biopharmaceuticals plans to hold an online briefing on the 11th to explain the background of the Partial Clinical Hold, the status of clinical progress, and its future response plans.

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