Invion aims for Phase 3 smoking cessation trial

Respiratory technology company Invion (ASX:IVX) has announced additional results from the ongoing analysis of its Phase 2 clinical trial of INV102 (nadolol) in patients trying to quit smoking. The randomised, double-blinded, placebo-controlled study was conducted on 155 patients at multiple US trial sites.

INV102, a beta blocker with inverse agonist and biased ligand activity, is being developed as a potential treatment to aid smoking cessation in patients with chronic cough. It is hypothesised to work via the inhibition of a cellular pathway (the beta arrestin pathway) that is pivotal in causing cells lining the lungs to change from normal to abnormal mucus-producing cells.

The initial study results, released last month, showed that smokers administered INV102 were more likely to stop smoking than those administered a placebo (19.3%, compared to 11%) or to dramatically reduce the number of cigarettes smoked (61%, compared to 36%). The drug additionally reduced key biomarkers MUC5AC and ERK1 in collected sputum samples, indicating a novel mechanism of action directly targeting epithelial cells lining the airway.

Invion said at the time that there would be ongoing analysis of data generated to examine which patients responded to INV102 therapy and if this correlated with any of the several biomarkers measured in the sputum samples collected. The new analysis demonstrates that treatment with INV102 shows a significant decrease in MUC5AC — one of the major biomarkers reflecting mucous metaplasia in airways — independent of an effect on markers of inflammation.

Invion recently submitted a request for an End of Phase 2 Meeting with the US FDA, said to be warranted by the combination of safety, tolerability of titration, cigarette reduction and biomarker effects to have come out of the study. Invion Chief Medical Officer Dr Mitchell Glass explained that the company will be using the meeting to pitch a Phase 3 study to take place in the near future.

“We are proposing to the FDA that an End of Phase 2 meeting be convened early in 2016 to move this drug into Phase 3 development,” Dr Glass said.

“Based on our results from eight weeks of dosing in the present study, we will focus our FDA discussions on achieving and maintaining abstinence over a longer dosing period.”

Invion Managing Director and CEO Dr Greg Collier added that the smoking cessation trial underpins the company’s broader agenda to develop INV102 as “a first-in-class treatment for chronic airway conditions like asthma, COPD and cystic fibrosis”.

Invion (ASX:IVX) shares were trading 12.5% higher at $0.009 as of around 12.30 pm on Tuesday.

Image credit: ©iStockphoto/KatarzynaBialasiewicz