Icagen, Inc. reported that the company successfully completed the phase I multiple ascending dose clinical trial of senicapoc, a novel orally available small molecule inhibitor of the KCa3.1 potassium ion channel, that is being developed for the treatment of asthma.

Study results showed that senicapoc was well tolerated at all doses tested and in preliminary analyses exhibited predictable and dose proportional pharmacokinetics consistent with once-daily dosing. There were no serious adverse events and no dropouts from the study. Additionally, there were no dose-limiting toxicities in any subject. The company expects to initiate a phase II proof-of-concept clinical trial in asthma during the second half of 2008.

Senicapoc is a potent and selective novel small molecule inhibitor of the potassium ion channel KCa3.1. This drug candidate is taken orally and is being developed for once-a-day dosing for the treatment of asthma. During the prior development program for sickle cell disease, senicapoc had previously been studied in multiple Phase I and nonclinical studies, including two year carcinogenicity studies.

"We are encouraged by these study results, which support the dosing of senicapoc at higher levels than those previously tested in clinical trials, and we look forward to advancing this novel compound to the next phase of clinical development," stated Seth V. Hetherington, senior vice president of Clinical Development and Regulatory Affairs at Icagen. "Senicapoc represents a potential new oral therapy with an innovative mechanistic approach for people suffering from asthma."

The multiple ascending dose study was designed to assess the safety, tolerability and pharmacokinetics of senicapoc in healthy volunteers at doses higher than those that have been tested in previous clinical studies. A total of four cohorts, consisting of either six or twelve subjects each, were administered the drug orally once a day for periods ranging from seven to twenty-eight days, and were followed for a period of approximately two months following the last dose.

The initial phase II proof-of-concept study is expected to be conducted in patients with allergen induced asthma. The company expects to enrol approximately thirty subjects in a short-duration study to examine the effect of senicapoc upon certain pulmonary function parameters following exposure of asthmatic patients to a known antigen. The study will be conducted at selected sites in the United Kingdom.

In January 2008, Icagen reported that the US Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for senicapoc as a potential treatment for asthma. The IND submission was supported by a growing body of data linking KCa3.1 to immune cell activation and cellular proliferation, as well as efficacy data from a nonclinical study that demonstrated the ability of senicapoc to reverse the antigen induced changes in late phase airway resistance and airway hyper-reactivity in an in vivo asthma model.

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.