Trial fails to demonstrate improvement in the primary study endpoints
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Icagen has reported top-line results from its phase IIa exercise-induced asthma study, senicapoc. The trial failed to demonstrate improvement in the primary study endpoints, including maximum decrease in FEV1, time to recovery of FEV1 after exercise and area under the FEV1 curve for sixty minutes.
In this double blind placebo-controlled study, 69 patients were randomised to receive either senicapoc at a maintenance dose of 40mg/day or placebo. All subjects were tested for pulmonary function following a standardised treadmill exercise regimen at baseline, two and four weeks after treatment.
The results of the pulmonary function tests were compared between the treatment groups, adjusting for differences in baseline values
Although the company will continue to evaluate the data from this trial, it does not anticipate continuing clinical development of senicapoc at this time.
Seth Hetherington, managing director of clinical development and regulatory affairs at Icagen, said: “We completed two small, cost-effective, proof-of-concept clinical studies testing the potential of senicapoc in the treatment of asthma. While we were encouraged by the results in our first study of allergic asthma, we were disappointed by the lack of effects in this second study of exercise-induced asthma.”
Kay Wagoner, president and CEO of Icagen, said: “Going forward we will focus on our lead program, the novel KCNQ opener ICA-105665, which is in phase IIa proof-of-concept trials in epilepsy and in pain, as well as on our preclinical programs, especially our collaboration with Pfizer for novel treatments for pain. Enrollment is going well in both the epilepsy and pain trials, and we are making progress in identifying clinical candidates in our Pfizer collaboration.”
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