News: Invion Limited completes Phase II dosing for smoking cessation drug

Invion Limited (ASX: IVX) has completed dosing in the Phase II clinical trial of its INV102 (nadolol) drug as an aid to smoking cessation.

Results from the trial, which is being performed in the U.S. under the company’s Investigational New Drug (IND) application, are anticipated to be released in Q3 2015.

The trial was designed to provide further testing of three hypotheses concerning the effects of
INV102 (nadolol) on the airway epithelium:

– the impact of nadolol on biomarkers of airway inflammation, β-arrestin pathway activation and abnormal mucus production;
– the safety and efficacy of nadolol as an aid to smoking cessation in patients with increased cough and sputum (phlegm) production who have repeatedly failed to quit; and
– the correlation of biomarkers of airway healing with cigarette smoking reduction or cessation, in order to optimise the nadolol regimen and patient selection for planned phase III clinical trials.

Results from this trial could pave the way for an entirely new approach to the treatment of chronic respiratory diseases like COPD, cystic fibrosis and severe asthma and could provide novel intellectual property if correlations provide insights to safety or efficacy linking nadolol usage to specific profiles of biomarkers.

An interim examination of data has already provided highly encouraging data and important insights into this population of difficult to treat cigarette smokers.

Success has the potential to unlock multi-billion markets.

The global market for new respiratory disease treatments is estimated at $34 billion, with the smoking cessation drug market estimated at $2.4 billion in 2012.

Nicotine replacement therapy is the bulk of the existing market, however these therapies do not address lung healing.

There is a substantial untapped market for a therapy that can work to heal lungs in concert with efforts to break nicotine addiction.