Icagen Initiates Phase II Allergic Asthma Trial
Posted on: Friday, 10 October 2008, 09:00 CDT
Icagen, a biopharmaceutical company, has initiated a Phase II proof-of-concept clinical trial to evaluate the safety and efficacy of senicapoc, the company's orally available small molecule inhibitor of the KCa3.1 potassium ion channel, in patients with allergic asthma.
This Phase II trial is a double-blind, placebo-controlled, parallel group study that is designed to assess the safety and efficacy of senicapoc, administered once a day for two weeks, on pulmonary function in patients with allergic asthma following exposure to a known antigen. The study will enroll approximately 30 patients randomized in a 1:1 ratio to senicapoc or placebo at sites in the UK.
The primary efficacy analysis of this Phase II study 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. FEV1 is a standard, commonly used test to measure lung function.
Results from a preclinical study demonstrated the ability of senicapoc to reverse antigen-induced increases in airway resistance and airway hyper-reactivity. The objective of the current trial is to confirm these positive results in a clinical setting.
Seth Hetherington, senior vice president of clinical development and regulatory affairs at Icagen, said: "We are very pleased to reach this significant milestone in the development of senicapoc for asthma. Senicapoc, with its novel mechanism of action, represents a potential new oral therapy for people suffering from asthma, and we look forward to having the top-line data from the trial, which we expect to be available in 2009."
Source: Datamonitor
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