Invion Limited, an Australian clinical-stage drug development company focused on the development of treatments for major market opportunities in inflammatory diseases including asthma, chronic bronchitis and lupus, recently announced the completion of dosing in INVSC001, a Phase II clinical trial assessing the efficacy and safety of a beta-adrenoceptor inverse agonist called nadolol in smoking cessation of patients with pre-existing COPD.
INV102 (nadolol) is a beta blocker being repurposed to treat inflammatory airway diseases. It will now be assessed in this new Phase IIB, randomized, double-blind, placebo-controlled study under an Invion-sponsored Investigational New Drug (IND) application. The release of results from this trial are expected in the last trimester of 2015.
The clinical trial will assess the effect of the drug on β-arrestin pathway activation, which is biomarker for airway inflammation and abnormal mucus production. The company is evaluating the efficacy and safety of the drug as an aid to smoking cessation in patients with increased sputum (phlegm) production and cough who have failed to quit smoking.
The trial will also examine the association of airway healing biomarkers with cigarette smoking reduction or cessation so that the nadolol regimen can be optimized for patient selection for future phase III studies.
Data derived from this trial could mean a breakthrough in the treatment of conditions such as cystic fibrosis, severe asthma and COPD, providing new intellectual property if the results show drug correlations between its safety and efficacy to specific biomarker profiles.
Results from an interim analysis have provided encouraging data regarding the effect of the drug in difficult to treat cigarette smokers. Specifically, the results showed that these individuals showed improvements in inflammatory markers and β-arrestin pathway activation in patients treated with nadolol versus placebo, regardless of smoking status.
The company and the trial lead researcher Dr, Mario Castro of Washington University, St Louis, recently reported that patients with sputum and cough and who still smoke showed the same abnormalities in their sputum at baseline, expanding the oral nadolol target population.
Invion’s Chief Medical Officer Dr Mitchell Glass said in a recent news release that completion of dosing was an important milestone. “This means that safety and tolerability of titration has been established in this vulnerable population — there is no indication that patients who received nadolol versus placebo were adversely affected. All existing data from previous nadolol studies have validated Invion’s novel approach to treating the airway epithelium, even in the face of ongoing insult like cigarette smoking.”
Dr. Glass concluded in the news release, “The team at Invion is actively engaged in validating the extensive data set to enable the forthcoming statistical analyses.”