Icagen has initiated the proof-of-concept study for ICA-105665 in patients with photosensitive epilepsy. ICA-105665 is a novel, orally available opener of subtypes of KCNQ channels, which have been validated by both genetic and physiologic evidence as playing an important role in certain conditions characterised by abnormal neuroexcitability, such as seizures, and potentially also chronic pain disorders.
The photosensitive epilepsy study was designed with international experts including members of the Epilepsy Study Consortium and will be conducted at up to four clinical research centers in the US with specialised expertise in the conduct of this study. The company said that the eligible subjects should demonstrated epileptiform activity by electroencephalogram (EEG) in response to photic stimulation and represent a small subset of all patients with epilepsy. Successive cohorts consisting of four patients each will be studied at each dose level, beginning at 100mg.
In accordance with a standardised protocol, patients receive single doses of placebo or ICA-105665 on successive days followed by photic stimulation with EEG monitoring. The study measures the ability of ICA-105665 to reduce the photic-induced epileptiform EEG responses, with the response observed in each cohort used to determine the subsequent dose for the next cohort. The study is expected to be completed by mid-2010.
Seth Hetherington, SVP of clinical development and regulatory affairs of Icagen, said: “We are pleased to announce the initiation of the photosensitivity study. This study design has been successfully employed in the development of several antiepileptic drugs. Because of the direct correlations that can be made between plasma levels of ICA-105665 and EEG activity, we expect to collect important information regarding both the efficacy and therapeutic dose range of this novel compound. We believe that the data provided by this focused, cost-effective study will be very useful in planning for a subsequent larger phase IIb trial in patients with chronic treatment-resistant epilepsy.”