Invion announces interim data in smoking cessation trial
Released
Released
Announcement PDF
ASX / MEDIA ANNOUNCEMENT
19 January 2015
INVION ANNOUNCES POSITIVE INTERIM DATA FROM ITS
PHASE II CLINICAL TRIAL OF ORAL INV102 (NADOLOL)
IN SMOKING CESSATION
Invion Limited (ASX: IVX) is pleased to announce positive interim data from its phase II double-blind
placebo-controlled randomised clinical trial in patients with chronic cough or established COPD who
are trying to quit smoking but have failed multiple times previously.
The interim data is generated from an assessment of sputum (phlegm) samples collected from patients
upon reaching (i) a maximum tolerated dose of drug (visit 6), and (ii) four weeks of maximum tolerated
dose treatment (visit 7).
The blind-broken analysis shows clinically relevant changes in four biomarkers of inflammation in
INV102 (nadolol) treated patients compared to placebo. For those patients receiving INV102 (nadolol):
IL-8, a powerful chemoattractant for inflammatory cells, was stable between visits 6 and 7, with
a median decrease in IL-8 levels compared to placebo which showed a median increase in
IL-8 levels;
ERK2, a biomarker for the beta arrestin pathway, showed a greater median decrease than
placebo-treated patients resulting in a lower median value at visit 7 (487 v 1,910 pg/mL);
MUC 1, a glycoprotein that lines the surface of epithelial cells in the lung, showed a modest
median decrease in patients receiving nadolol and placebo; and
Neutrophils, the white blood cells that are the hallmark of inflammation of chronic bronchitis
decreased 7% (mean) versus a mean increase of 1.4% in placebo patients.
Dr Mitchell Glass, Executive VP of R&D and Chief Medical Officer said: “These results are exciting to
Invion and this field of research for three primary reasons. First, we have clear and clinically meaningful
separation between subjects treated with nadolol versus placebo in four areas of biomarker
investigation. Second, the pattern of individual neutrophil changes from visit 6 to visit 7 indicates a
response to nadolol treatment. Third, ERK1/2 is a hallmark of the beta arrestin pathway, the blockade of
which is central to our hypothesis concerning the unique mechanism of action of nadolol. Analysis is
ongoing of MUC5AC, the abnormal mucin which is specific to COPD, which will further inform us about
airway healing.”
“We recognize that we must interpret these results with caution, given their interim nature, the sample
size, and the variability that naturally occurs in sputum analysis. However the results support our
hypothesis regarding the clinical, regulatory and commercial potential of INV102 (nadolol), and also
provide a strong foundation to our inhaled INV102 program, which is approaching a major
development milestone.”
Laboratory analyses were performed at Washington University, St Louis, MO, USA under the supervision
of Dr Mario Castro, the Principal Investigator of the smoking cessation trial.
Investors can hear Dr Mitchell Glass on BRR as he discusses today’s announcement and results, via this
link: http://webcasting.brrmedia.com/broadcast/133437
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
ASX / MEDIA ANNOUNCEMENT
FOR MORE INFORMATION CONTACT: Managing
P: + 61 7 3295 0500 E: greg.collier@inviongroup.com
Director
and
CEO,
Dr
Greg
Collier
About Invion Limited
Invion is a life sciences company focussed on the development of treatments for major opportunities in
respiratory disease and autoimmune disease. The Group has three drug assets in development, three
phase II clinical trials and two clinical feasibility programs currently underway. INV102 (nadolol), a beta
blocker (beta adrenergic inverse agonist) currently used to treat high blood pressure and migraine, is
being repurposed to treat chronic inflammatory airway diseases, including asthma and chronic
obstructive pulmonary disease (COPD). INV104 (zafirlukast) is a leukotriene receptor antagonist (LTRA)
or anti-leukotriene that reduces inflammation, constriction of the airways, and the build-up of mucus in
the lungs. INV103 (ala-Cpn10) is a modified, naturally occurring human protein which has been
proposed as a founding member of the Resolution Associated Molecular Pattern (RAMPs) family
hypothesised to maintain and restore immune homeostasis. Invion is an ASX listed company (ASX:IVX),
with operations in Brisbane, Australia and Delaware, USA.
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
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