A Phase 2 study of Invion’s INV102 inhaled nadolol showed that smokers using the therapy were much more likely to stop smoking or significantly reduce the number of cigarettes they smoked than those using a placebo, the company said.
The randomized, double blinded, placebo controlled study also showed a significant reduction in biomarkers for the beta arrestin pathway in the sputum. with an 82% reduction in MUC5AC levels for patients using INV102 versus 54% for placebo and a 47% reduction in ERK1 levels for INV102 versus 27% for placebo. The 155 patients enrolled in the study had all previously attempted to quit smoking but gave up due to symptom’s of “smoker’s cough” caused by mucus build-up.
Invion Chief Medical Officer Mitchell Glass said, “These positive Phase 2 data validate our approach for directly treating the airway epithelium even in the face of ongoing insult, such as cigarette smoking. This is the first indication that epithelial damage can be treated directly by a drug. There are currently no approved drugs capable of treating the change in the airway epithelium and these results pave the way for a potentially novel and better way of treating chronic airway diseases.”
Managing Director and CEO Greg Collier added, “Investors should note that this smoking cessation study is our ‘short path to market’ strategy. Crucially, these results will underpin our broader agenda — to immediately develop this drug as a first in class treatment for chronic airway conditions like asthma, COPD and cystic fibrosis where there is a substantial unmet medical need and commercial opportunity.”
The company said that it wants to hold its end of Phase 2 meeting with the FDA in early 2016. Invion recently announced that it had raised A$1 million through a private placement.
Read the Invion press release.