Drug development company Icagen is now free to move ahead with clinical trials on its epilepsy drug candidate after regulators removed a hold placed on the compound for safety concerns.
Last September, Icagen (NASDAQ:ICGN), based in North Carolina’s Research Triangle Park, suspended enrollment in clinical studies of its compound ICA-105665 due to the occurrence of “a serious adverse event” in a photosensitivity study. The U.S. Food and Drug Administration subsequently put a clinical hold on development. Icagen announced on Feb. 2 that the hold has been removed. The FDA made the decision after reviewing both data from completed clinical studies as well as Icagen’s proposed protocol for a phase II clinical trial in patients with treatment-resistant epilepsy.
Icagen’s drug development focuses on compounds that modulate ion channels, protein structures found in the cells of the human body. ICA-105665, the company’s lead drug candidate, works by opening a channel that in preclinical studies demonstrated a spectrum of activity in epilepsy and pain.
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“We are pleased with the FDA’s action and will shortly be determining the next steps in the clinical development of our epilepsy drug candidate, ICA-105665,” Icagen President and CEO Kay Wagoner said in a statement.
