Invion, Inc. is currently enrolling 136 patients with chronic obstructive pulmonary disease (COPD) for a Phase 2 clinical trial evaluating its drug INV102 (nadolol). The goal of the study is to establish the safety and efficacy of nadolol while improving smoking cessation in patients with COPD.
Often when smokers quit smoking, chronic coughing is discouraging. Within the first two weeks of quitting smoking, coughing to remove thick mucus built up in the bronchial tubes leads many COPD patients to return to smoking to stop their coughing.
Invion formulated nadolol with the intention of reducing mucus buildup in the airways. Nadolol suppresses secretion of IL-13, an inflammatory molecule that causes mucous cells (known as goblet cells) to secrete mucus. As a result, nadolol treats the cause of chronic cough and may expedite airway healing and increase smokers’ success rate in quitting.
Invion is testing its theory through its Phase 2 study of nadolol versus placebo. The treatment span will be 11 to 15 weeks, during which time the primary outcome measured will be a change in the number of cigarettes smoked per day in a week. The study is estimated to complete in December 2014.
“The data generated from this trial will not only potentially advance a novel therapy for smoking cessation, but it will also add to the already strong data package in our wider asthma and COPD program,” said Dr. Greg Collier, Managing Director and Chief Executive Officer of Invion, in a news release. “This is a very exciting time for this company.”
It is hoped nadolol will have overarching benefits for multiple patient types and even smokers with no current illnesses. “Tobacco is a known or probable cause of at least 25 disease, including cancers, heart disease, stroke, emphysema, and other chronic lung disease,” said Dr. Mitchell Glass, Executive VP of Research and Development and Chief Medical Officer of Invion. “People who smoke have higher rates of serious complications following surgical procedures, and about one in two regular smokers dies of a smoking related disease, reducing their life expectancy by 16 years on average. This is a significant global health problem and represents an enormous commercial opportunity. A therapy [such as nadolol] which can reduce or eliminate smoker’s cough, a common barrier to quitting smoking, could be life changing for patients.”
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