It has been a pleasure coming onboard as Invion’s CEO, meeting with shareholders in Australia and having a chance to share our vision for the future of the company. This newsletter is an extension of that, giving shareholders we haven’t met yet a chance to review our plans and assets, and learn more about why we believe Invion is one of the most exciting new opportunities in biotechnology on the market.
There is a lot of work ahead in 2013. We have just announced initiation of our phase II trial of INV102 in asthma, which is being funded by a US$4.4 million grant from the National Institutes of Health (NIH). The NIH are the primary agency of the United States government responsible for biomedical and health-related research, and are funding the trial under our Investigational New Drug (IND) application through a cooperative agreement grant to Baylor University, with additional sites at Duke University and Washington University.
Securing the NIH grant was a powerful boost to the company, in terms of non-dilutive capital support, the underpinning INV102 data gathered in clinical trials conducted so far, and the validation of our trial design.
The asthma trial will provide further valuable data around INV102’s effect on ‘airway hyperresponsiveness’ (the likeliness of the airways to tighten or spasm), which is a crucial part of assessing the drug’s potential as a treatment for chronic obstructive lung diseases.
The trial will also provide valuable information around the precise mechanisms through whichINV102 works. As you may know, to date, two phase II clinical trials of INV102 have been completed which demonstrated acceptable safety as well as dose-related reduction of airway hyper-responsiveness.
We will soon also be announcing patient dosing in our phase II trial assessing INV102 as an aid to smoking cessation in patients with chronic bronchitis. Invion believes INV102’s action will significantly reduce “smoker’s cough”, a symptom of the smoking cessation period which causes many smokers to relapse.
Research to date suggests INV102 will tackle smoker’s cough by restoring the inflamed airways responsible for producing the mucus that causes the cough. A therapy which can reduce or eliminate smokers cough could be life changing for patients.
Being able to commence two new phase II trials for an asset that has already generated positive phase II data is an enviable position for Invion to be in, and part of the rationale for the company’s creation. We believe we have identified an opportunity to take an existing drug (INV102) into new indications and generate considerable value from this clearly mapped repurposing. Our Chief Medical Officer Dr Mitchell Glass speaks more on this in an article later in this newsletter.
Rounding out our portfolio is our INV103 (ala-Cpn10) asset, which has considerable preclinical support for its efficacy as a modulator of the immune system. This drug holds potential for use in treating diseases where the immune system has drifted from normal functioning, such as the common autoimmune disease, SLE (lupus).
In recent weeks the company met with the Pulmonary, Allergy and Rheumatology Products Division of the FDA’s Center for Drug Evaluation and Research for its pre-IND meeting for INV103 (ala-Cpn10), and we are now moving forward with our clinical development plan.
I look forward to continuing to share Invion’s progress with you, and send my best wishes for 2013.
Dr William Garner, CEO.