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Invion Limited Progress Update: Inv102 Phase 2 Clinical Programs

12/19/2012 11:10:32 AM

19 December 2012 -- Invion Limited (ASX:IVX) today announced an update on its clinical development programs for INV102 (nadolol).

Invion’s phase II clinical trial investigating the use of INV102 in patients with mild asthma known as ‘NIMA’ (for ‘nadolol in mild asthma’) is operating under an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA).

The multi-centre study is being funded by the US National Institutes of Health (NIH) and is being conducted in partnership with Baylor University (Texas), Duke University (North Carolina), and Washington University (St Louis).

INV102 drug for the study has been manufactured and is ready for shipment to trial sites. A successful Investigators Meeting was held in October with the study’s investigators and key clinical staff.

A non-critical delay to formal initiation of the study is the result of final Institutional Review Board (IRB) approval remaining pending. This is expected in the coming weeks.

Invion’s ‘Smoking Cessation’ trial, also operating under IND with the FDA, is a phase II, double blind, randomized, placebo-controlled study of INV102 versus placebo in facilitating smoking cessation in subjects with chronic bronchitis and increased cough and sputum (mucus).

The study is being carried out in collaboration with the Christiana Healthcare Centre in Newark (Delaware). The Principal Investigator is Albert A. Rizzo, M.D., immediate past-chair of the National Board of the American Lung Association.

INV102 drug for the study has been manufactured and is ready for shipment to trial sites and a successful meeting with the Principal Investigator and co-Principal Investigator was held earlier this month. Final IRB approval remains pending.

Invion looks forward to updating shareholders in coming weeks with news of subject enrolment into both of these studies.

“INV102 is Invion’s lead drug candidate and we are eager to begin enrolling patients into phase II clinical trials in two indications: smoking cessation and asthma. Both studies represent important opportunities for Invion and whilst there has been a short unavoidable delay to the commencement of patient enrolment, we expect this will have little overall impact on the timing of the clinical trial program,” said Dr William Garner, Chief Executive Officer.

About the Asthma Study

‘NIMA’ is a multi-centre, 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 which was originally developed in Australia at the University of New South Wales). Secondary objectives include safety, signs and symptoms and biomarkers.

About the Smoking Cessation Study

‘Smoking Cessation’ (Protocol Number INVSC001) is a single-centre study enrolling up to 120 patients. All subjects on this study will be titrated either to their maximally tolerated dose or placebo where they will be maintained for four to six weeks. The primary objective of the study is smoking abstinence at end of active dosing. Secondary objectives include assessing the tolerability of INV102 in patients who are attempting to quit smoking, the safety and effectiveness of titration to assess the duration of cessation and any symptoms, including cough, and the effect on pre-operative complications in a subset of subjects who are referred for smoking cessation prior to a major surgical procedure.

About INV102

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.

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