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Weekly UpdatesIcagen, Inc. (Nasdaq:ICGN), Research Triangle Park. N.C. has reported the completion of enrollment in the company's Phase II proof-of-concept study of senicapoc in patients with allergic asthma. Initial results from this study are expected during the second half of this year.
As previously reported, 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 United Kingdom 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. FEV1 is a standard, commonly used test to measure lung function.
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 United States. 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 the year.
Senicapoc is a novel orally available small molecule inhibitor of the KCa3.1 potassium ion channel. Literature data suggests a potential role for inhibitors of KCa3.1 in the treatment of a wide variety of inflammatory and immune-mediated diseases, including asthma. Results from preclinical studies demonstrated the ability of senicapoc to reverse antigen-induced increases in airway resistance and airway hyper-reactivity.
"We are very pleased to have achieved another important milestone in the development of senicapoc for asthma," stated Seth V. Hetherington, M.D., senior vice president of Clinical Development and Regulatory Affairs at Icagen. "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 this year."
About Senicapoc
Senicapoc is a potent and selective novel small molecule inhibitor of the potassium ion channel KCa3.1. This drug candidate is taken orally and is being developed for once-a-day dosing for the treatment of asthma. Senicapoc has previously been studied in multiple Phase I and nonclinical studies, including two year carcinogenicity studies. Two separate Phase II proof-of-concept clinical trials of senicapoc as a treatment for asthma are currently ongoing, one focused on allergic asthma and the second focused on exercise-induced asthma.
About Asthma
Asthma is a chronic inflammatory disease of the airways characterized by excessive sensitivity of the lungs, or increased reaction of the airways, to various environmental stimuli or triggers. The inflammation results in narrowed, swollen airways and increased mucus, and frequently is accompanied by constriction of the smooth muscle in the airways, or bronchoconstriction, causing difficulty breathing and the familiar wheeze often associated with the disease. While asthma cannot be cured, most people with asthma can be treated so that they have few and infrequent symptoms and can live active lives. According to the National Heart Lung and Blood Institute, about 20 million people have been diagnosed with asthma in the United States, nearly nine million of whom are children.
About Icagen
Icagen, Inc. is a biopharmaceutical company based in Research Triangle Park, North Carolina, focused on the discovery, development and commercialization of novel orally-administered small molecule drugs that modulate ion channel targets. Utilizing its proprietary know-how and integrated scientific and drug development capabilities, Icagen has identified multiple drug candidates that modulate ion channels. The company is conducting research and development activities in a number of disease areas, including epilepsy, pain and inflammation. The company has clinical stage programs in epilepsy and asthma.
For more information, call 919/941-5206.
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