ASX / MEDIA ANNOUNCEMENT INVION PHASE 2 SMOKING CESSATION DATA: RESULTS OF ONGOING ANALYSIS
Invion Limited ABN 76 094 730 417
GPO Box 1557, Brisbane, QLD, 4001. P +61 7 3295 0500 F +61 7 3295 0599 www.inviongroup.com
- Ongoing analysis confirms headline data on safety profile: analysis of adverse events shows no difference between active treatment and placebo groups
- Nadolol treatment significantly decreased MUC5AC levels compared to placebo treatment confirming improvements in mucous metaplasia
Brisbane, Australia and Delaware, United States, 17 November 2015: Australian respiratory technology company Invion Limited (ASX: IVX) is pleased to announce additional results from the ongoing analysis of the company’s Phase 2 clinical trial of INV102 (nadolol).
The ongoing analysis, which forms part of the pre-specified statistical analysis plan (SAP), demonstrates that treatment with INV102 (nadolol) shows a statistically significant effect on biomarker MUC5AC independent of an effect on markers of inflammation.
MUC5AC, which is one of the major biomarkers reflecting mucous metaplasia in airways, was statistically significantly decreased from baseline to the end of maintenance at visit 8 in an analysis of all subjects who completed titration. MUC5AC and other biomarkers are being analysed further to determine whether baseline levels or biomarker responses during treatment define a more targeted population for Phase 3 studies.
This ongoing data analysis has contributed to submission of an abstract to the 2016 American Thoracic Society (ATS) annual meeting.
The combination of safety, tolerability of titration as reflected by the majority of subjects reaching the top dose of 100mg/ day, cigarette reduction and biomarker effects, have provided a strong basis for the recently submitted request for an End of Phase 2 Meeting with the US FDA.
Invion Chief Medical Officer Dr Mitchell Glass said “The ongoing data analysis continues to indicate an interaction between this key marker, MUC5AC, and the ability of patients to quit smoking who have previously failed to quit due to chronic cough. We are also continuing to analyse smoking reduction or cessation as a function of baseline levels or changes in other biomarkers.
“Although our Phase 2 study was necessarily complex, our Phase 3 study design will likely be more straightforward. 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 in this difficult to treat population. We have already developed our diary cards, data management processes and criteria for selecting sites with large numbers of appropriate patients enrolled in validated smoking cessation programs.
“We believe these results not only support the implementation of a Phase 3 program to achieve smoking cessation in patients, but also confirm inhaled INV102 (nadolol) as a target for chronic airway diseases including asthma, COPD and cystic fibrosis. In inhaled INV102 studies, we will continue to evaluate biomarkers for prognostic value of safety or efficacy and response to therapy.
INV102 (nadolol), 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 due to its demonstrated effect in murine models in reducing goblet cell metaplasia and airway inflammation. 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.
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