Icagen Inc late last week announced the successful completion of the phase 1 multiple ascending dose clinical trial for senicapoc, a novel orally available small molecule inhibitor of the KCa3.1 potassium ion channel being developed for the treatment of asthma.

Results indicate that the drug was well tolerated at all doses tested and in preliminary analyses exhibited predictable and dose-proportional pharmacokinetics consistent with once-daily dosing. 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. There were no serious adverse events and no dropouts from the study.

"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," said Seth V. Hetherington, senior vice president of Clinical Development and Regulatory Affairs at Icagen. The company hopes to begin a phase 2 proof-of-concept trial later this year. "Senicapoc represents a potential new oral therapy with an innovative mechanistic approach for people suffering from asthma."

In January, the US Food and Drug Administration accepted Icagen's Investigational New Drug (IND) application for senicapoc. 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 demonstrating the ability of senicapoc to reverse the antigen-induced changes in late phase airway resistance and airway hyperreactivity in an in vivo asthma model.