Icagen, Inc reported that the FDA has lifted the partial clinical hold related to the development of ICA-105665, the company's novel orally available small molecule KCNQ potassium channel agonist, for the treatment of epilepsy. Accordingly, the company is planning to initiate a proof-of-concept study in patients with photosensitive epilepsy.
The photosensitive epilepsy study was designed with international experts including members of the Epilepsy Study Consortium and will be conducted at multiple clinical research centers in the US. Eligible subjects are those patients with demonstrated epileptiform activity by electroencephalogram (EEG) in response to photic stimulation (also called a 'photoparoxysmal response to light') and represent a small subset of all patients with epilepsy. In accordance with a standardized 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. The duration of an observed effect will also be measured over time. A range of doses of ICA-105665 will be studied in successive cohorts, and the response observed in each cohort will determine the subsequent dose for the next cohort. The objective of the study is to determine a potential dose range to study in subsequent, more advanced clinical trials. The study is anticipated to be completed by mid-2010 but interim results may be available earlier.
In addition, the company continues preparations for a proof-of-concept pain study, which is also expected to be initiated during the third quarter. This study will be conducted at a single clinical research site in the United Kingdom. The pain trial involves the study of healthy volunteers exposed to mildly painful stimuli under controlled conditions. The study will employ a triple cross-over design comparing the ability of ICA-105665, ibuprofen and placebo to decrease the sensation of pain in response both to the injection of a small amount of capsaicin under the skin and to a simulated sunburn. Initial results from this study are expected by early 2010.
"We are pleased to be able to proceed with the development of ICA-105665 in patients with epilepsy," noted Seth V Hetherington, SVP of Clinical Development and Regulatory Affairs of Icagen. "This compound is a highly selective agonist of KCNQ channel subtypes, and has demonstrated excellent activity in a broad range of preclinical epilepsy models. Additionally, in a single dose Phase I study as well as a multi-dose Phase I study comprised of both healthy volunteers and patients with epilepsy, ICA-105665 has been well tolerated at doses ranging from 30 to 400mg per day, the highest dose tested. We look forward to conducting both the photosensitive epilepsy trial and the pain trial with the goal of establishing proof-of-concept for this novel compound in epilepsy and pain."
Icagen 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.