Icagen Releases Positive Results Of Phase IIa ICA-105665 Trial

Icagen said that the photosensitive epilepsy study was a placebo-controlled, single blind study conducted at two clinical research centers in the US with specialised expertise in the conduct of this study.

The study was designed in collaboration with a group of international experts including members of the Epilepsy Study Consortium, and followed a standardised protocol that has been utilized in the development of several anti-epileptic agents. The photosensitive epilepsy model is considered by experts in the field to be useful in establishing proof-of-concept for the treatment of epilepsy. Many currently marketed anti-epileptics have been shown to be effective in these patients.

In the study, the eligible subjects were those patients with demonstrated epileptiform activity by electroencephalogram (EEG) in response to photic stimulation and represent a small subset of the epilepsy population. All subjects continued background therapy with their concomitant anti-epileptic medications through the testing period.

Reportedly, the study measured the ability of ICA-105665 to reduce the photic-induced epileptiform EEG response by comparing the response to a single administration of ICA-105665 with the response to placebo. All EEGs were reviewed by a centralised reader on a blinded basis.

At the top dose studied (400mg/day), two of four patients demonstrated a positive response to treatment with ICA-105665, as specified by standard pre-defined criteria. At all dose levels tested, ICA-105665 was well tolerated.

Jacqueline French, professor and director of the clinical trials consortium at the NYU Comprehensive Epilepsy Center, said: “The trial met its endpoints. While more studies will be required to establish the potential utility of this compound in the treatment of epilepsy, the results of this photosensitive epilepsy model provide important proof-of-concept data for this novel drug candidate.”