Icagen Reports Top Line Results For Phase IIa Senicapoc Study

Icagen has reported top line results of a randomized, double-blind, placebo-controlled, proof-of-mechanism phase IIa study of senicapoc in allergic asthma.

Senicapoc reduced the late asthmatic response (LAR) to a challenge of inhaled allergen, the primary endpoint of the study, as determined by the decline in FEV1. The improvement in the average decline in FEV1 was 29%, in the maximum decline 18%, and in the area under the curve 28% of FEV1.

Compared to their respective baselines, patients receiving senicapoc demonstrated an improvement in all measures of the LAR, while those receiving only placebo treatments had no improvements in any measure of the LAR.

A total of 34 patients with demonstrated asthmatic responses to inhaled allergen were enrolled at two clinical research centers in the UK. Patients were randomized equally to receive either senicapoc or placebo administered orally once daily following an initial loading dose for a treatment period of approximately two weeks.

A secondary endpoint, the fraction of exhaled nitric oxide was reduced by 24% among patients who received senicapoc, compared to patients who received placebo.

An additional secondary endpoint, the early asthmatic response was unchanged, as expected from preclinical studies. Senicapoc was found to be well tolerated, and there were no serious adverse events in the study. Additional analysis and review of the data are ongoing.

Seth Hetherington, senior vice president of clinical and regulatory affairs at Icagen, said: We are pleased with the results of this study, and believe that they justify further evaluation of senicapoc as a novel approach to the treatment of asthma. We believe that the combination of the reduction in LAR among the senicapoc-treated patients, along with the improvement in the fraction of exhaled nitric oxide, is consistent with the potential for an anti-inflammatory effect of senicapoc, a selective blocker of the KCa3.1 channel.