SK Biopharm has announced a partial hold on the Phase 2/3 clinical trials for its epilepsy drug candidate, Opacalim, which it is developing in collaboration with Biohaven. The company stated that it was aware of the potential risks at the time of the contract and expects the hold to be lifted by late October to November.
According to SK Biopharm, Biohaven received notification from the U.S. Food and Drug Administration (FDA) on October 10, citing the need for additional nonclinical data as the reason for the partial hold on the trials.
The FDA requested further information to determine whether the toxicity observed in nonclinical toxicity studies involving specific metabolites of Opacalim in rodents is a species-specific phenomenon. As a result, new patient enrollment has been temporarily suspended, but treatment for existing clinical trial participants will continue.
SK Biopharm explained that prior to signing the contract, it reviewed this information and consulted external experts, concluding that the likelihood of similar issues arising in humans is low due to the species-specific nature of the findings.
During a conference call on the morning of the announcement, SK Biopharm stated, "We were aware of the risk of a clinical hold from the outset and believe the chances of similar issues occurring in humans are low." The company added, "We anticipate that the hold will be resolved by October to November."
To date, over 1,200 patients have participated in the clinical trials for Opacalim, and no adverse events directly related to the nonclinical toxicity findings have been identified. Biohaven plans to submit additional nonclinical study data regarding the specific metabolites to the FDA in hopes of lifting the clinical hold.
Meanwhile, SK Biopharm secured a contract worth up to $795 million (approximately 1.07 trillion won) last month for the global exclusive development and commercialization rights to Opacalim. This move follows the acquisition of the epilepsy treatment Cenobamate (Xcopri), as part of the company's strategy to expand its product portfolio.
* This article has been translated by AI.
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