Icagen (ICGN) Reports Positive Top Line Results of Phase IIa Study of Senicapoc
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Icagen, Inc. (Nasdaq: ICGN) reported today 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 to a challenge of inhaled allergen, the primary endpoint of the study, as 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% (p=0.06), in the maximum decline 18% (p=0.15), and in the area under the curve 28% (p=0.08) 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. The magnitude of the observed responses matched that anticipated in the study design, but the greater than expected inter and intra-patient variability resulted in a reduction of the power of the study.
A total of 34 patients with demonstrated asthmatic responses to inhaled allergen were enrolled at two clinical research centers in the United Kingdom. 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. An allergen challenge was conducted at screening to evaluate the baseline LAR, and again at the completion of the treatment period to determine changes in LAR by measuring changes in FEV1. Thirty one patients were evaluable for the study endpoints.
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% (p=0.10) 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. Consistent with other studies conducted to date, 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. The Company plans to present the complete results of the study at an upcoming scientific conference.
A total of 34 patients with demonstrated asthmatic responses to inhaled allergen were enrolled at two clinical research centers in the United Kingdom. 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. An allergen challenge was conducted at screening to evaluate the baseline LAR, and again at the completion of the treatment period to determine changes in LAR by measuring changes in FEV1. Thirty one patients were evaluable for the study endpoints.
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% (p=0.10) 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. Consistent with other studies conducted to date, 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. The Company plans to present the complete results of the study at an upcoming scientific conference.
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