Icagen, Inc. announced that due to the occurrence of a serious adverse event in the photosensitivity study of ICA-105665, the company has suspended further enrolment in the study. The serious adverse event occurred in the 600mg patient cohort following completion of the 500mg patient cohort.
The company will be discussing the status of the study with its clinical advisors and with the FDA. Additionally, the company has completed the conduct of the multiple ascending dose study in healthy volunteers at daily doses of 500mg and 600mg for a period of seven days. There have been no serious adverse events noted, pending a final review of laboratory data. Analyses of the complete data set from both studies are ongoing.
Icagen, Inc. is a biopharmaceutical company based in Research Triangle Park, North Carolina, focused on the discovery, development and commercialization of novel orally-administered small molecule drugs that modulate ion channel targets.