Icagen, Inc. has announced the initiation of a Phase I study of ICA-105665, a small molecule compound for the treatment of epilepsy.
ICA-105665 is an activator of certain subtypes of KCNQ ion channels for the potential treatment of a variety of neuroexcitability disorders such as epilepsy and pain. These channels underlie a potassium current called the M-current, which is important in the regulation of the resting potential and electrical firing of certain nerve cells.
Mutations in a specific subtype of KCNQ channels have been linked to an inherited seizure disorder, which provides genetic validation for this approach.
In preclinical studies, ICA-105665 has demonstrated activity in models predictive of efficacy for the treatment of partial seizures, generalized seizures and treatment-resistant seizures.
In addition, ICA-105665 has also been shown to have activity in certain preclinical models of neuropathic and inflammatory pain. In preclinical studies conducted to date, this compound has demonstrated a favorable safety and toxicity profile, the company says.
ICA-105665 is administered orally and is intended to be developed as a chronic therapy for patients with epilepsy and potentially other disorders characterized by abnormal neuronal excitability.
The initial Phase I clinical trial is a double-blind, placebo controlled single dose ascending study in healthy male volunteers designed to assess the safety, tolerability and pharmacokinetics of the compound. Provided that data from this study are supportive, a subsequent study will assess the tolerability and pharmacokinetics of multiple doses.