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Icagen Asthma Drug Gets Positive Results

Icagen, Inc. achieved positive results from a Phase IIa study of senicapoc in allergic asthma.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Icagen, Inc. achieved positive results from a 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, determined by the decline in FEV1, the volume of air that can be forcibly exhaled in one second. 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. Patients receiving senicapoc demonstrated an improvement in all measures of the LAR, while those receiving placebo had no improvements.

A secondary endpoint, the fraction of exhaled nitric oxide, a measure of airway inflammation that is typically elevated in asthmatic patients, 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. Senicapoc was well tolerated with no serious adverse events in the study. Additional analysis and review of the data are ongoing.

The company has completed enrollment in a randomized, double-blind, placebo-controlled trial of senicapoc in patients with exercise-induced asthma. Results from this second proof-of-concept study are expected during 4Q09.

“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,” said Seth Hetherington, M.D., Icagen’s senior vice president of Clinical and Regulatory Affairs. “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.”

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