The allergen challenge trial is a double-blind, placebo-controlled, parallel group study that is designed to assess the safety and efficacy of senicapoc administered orally on pulmonary function in patients with allergic asthma following exposure to a known antigen.
Approximately 30 patients at two research centers in the UK were randomized in a 1:1 ratio to senicapoc or placebo. The primary efficacy analysis is the comparison between treatment arms of the late asthmatic response caused by inhalation of allergen, measured by percent change in forced expiratory volume 1 (FEV1), the amount of air that can be forcefully exhaled in one second.
In addition to the allergen challenge study, Icagen is also conducting a Phase II proof-of-concept study in patients with exercise-induced asthma. This study will enroll approximately 60 patients at multiple centers throughout the US. Enrollment is proceeding according to expectations, with approximately one-half of the study subjects enrolled to date. Initial results from this study are expected during the second half of 2009.
Seth Hetherington, senior vice president of clinical development and regulatory affairs at Icagen, said: “We are very pleased to have achieved another important milestone in the development of senicapoc for asthma. With its novel mechanism of action, senicapoc represents a potential new oral therapy for asthma patients, and we look forward to having the results of this trial, which we expect to be available later in 2009.”