2 January 2013 -- Invion Limited (ASX:IVX), a clinical-stage drug development company targeting chronic inflammation,
today announced the initiation of “NIMA”, a phase II clinical trial that is funded by the US National
Institute of Allergy and Infectious Diseases (NIAID) to investigate the use of INV102 in patients with
The NIAID is part of the US National Institutes of Health (NIH), which are the primary agency of the
United States government responsible for biomedical and health-related research. The NIAID is
funding the “NIMA” trial via a cooperative agreement grant to Baylor University College of Medicine
of approximately US$4.4 million.
INV102, also known as nadolol, has been used in more than eight million people for the treatment of
high blood pressure, migraine and chest pain. Invion is repurposing nadolol and targeting it to the
treatment of inflammatory lung disease, including asthma and chronic bronchitis.
This trial will provide valuable data around INV102’s effect on airway responsiveness, a crucial part of
assessing INV102’s potential as a treatment for lung diseases such as asthma.
The global market for asthma and chronic obstructive pulmonary disease (COPD) prescription drugs
was valued at $34 billion in 2011. This figure is increasing at a five year compound annual growth rate
(CAGR) of 4.4%.
Dr Mitchell Glass, Chief Medical Officer said, “The development of INV102 in chronic inflammatory
diseases of the lungs is following the medical, regulatory and commercial precedent of the
development of beta blockers for use in chronic heart failure.”
“Once contraindicated, after careful titration beta adrenergic inverse agonists were shown to reduce
mortality in all classes of chronic heart failure and have now become the standard of care. Using
similar careful titration, INV102 is targeted to reduce airflow obstruction due to damaged airways and
provide a safe and effective therapy for the treatment of asthma,” Dr Glass said.
To date, two phase II clinical trials of INV102 have been completed which have demonstrated
acceptable safety as well as dose-related reduction of airway hyper-responsiveness. Chronic INV102
dosing resulted in a reduction in airway hyper-responsiveness comparable to results achieved with
inhaled corticosteroids for several weeks.
About the Study
“NIMA” for “nadolol in mild asthma” is a randomized trial that will enrol up to 60 subjects in three
centres in the United States. Randomized subjects will receive either INV102 or placebo and will be
progressively tested to the maximally tolerated dose of INV102 according to strict study criteria. The
trial will measure endpoints including airway hyper-responsiveness, signs and symptoms, use of
rescue medication (for example, inhalers) and, in a subset of subjects, airway evaluation of mucus
and biomarkers collected during bronchoscopy. These will form a data set providing further
information regarding INV102’s mode of action. The primary objective of the study is to assess
INV102’s effect on airway responsiveness to inhaled methacholine (a common test in the assessment
of lung conditions which induces narrowing of the airways). Secondary objectives include safety,
signs and symptoms and biomarkers.
INV102, a beta adrenergic inverse agonist also known as nadolol, has been used in more than eight
million people for the treatment of high blood pressure, migraine and chest pain. Invion is repurposing
nadolol and targeting it to the treatment of inflammatory lung disease, including asthma and chronic
bronchitis. Long-term exposure to beta adrenergic inverse agonists block cellular changes induced by
beta agonists, thereby inactivating the production of inflammatory cytokines and decreasing
sensitization to airway challenges. Of the three beta adrenergic inverse agonists, INV102 has
demonstrated the best inverse agonist activity in the airways. To date, two phase II clinical trials of
INV102 have been completed which have demonstrated acceptable safety as well as dose-related
reduction of airway hyper-responsiveness. Chronic INV102 dosing resulted in a reduction in airway
hyper-responsiveness comparable to results achieved with inhaled corticosteroids for several weeks.
About Invion Limited
Invion Limited is a clinical-stage drug development company that targets chronic inflammation.
Focussed on the development of treatments for major market opportunities in inflammatory diseases
including asthma, chronic bronchitis and lupus, Invion has two phase II proprietary therapeutic
candidates: INV102 – a repurposed beta adrenergic inverse agonist; and INV103 (Ala-Cpn10) – a
modified natural immunomodulator.
FOR MORE INFORMATION CONTACT:
Dr William Garner
Managing Director and CEO
03 9866 4722
(03) 9866 4722