In this interview, Aage shares his industry experience and connection with InsuLife, how InsuLife’s technology, a patented transdermally-delivered insulin spray - the investigational medicinal product Levellor - has the potential to revolutionize insulin administration.
Can you tell us about your background and how you started in the pharmaceutical industry?
I am a University of Oslo-educated pharmacist and have worked in the pharmaceutical industry for more than 40 years.
I came across the opportunity to become a member of the InsuLife team two years ago when Petter (Co-Founder and CCO) called me and asked whether I would join him in putting up a company around this concept of insulin given through a transdermal delivery system. I thought, 'this sounds too good to be true,' but knowing that one has to test and document new medicines, I realized that there was just one way of finding out. We needed to do clinical studies and see what comes of it.
It sounds almost unbelievable that a large molecule like insulin could pass through the skin, but if we can make it possible to spray insulin onto the skin instead of relying on needles to inject it, that would be a life-changing innovation for diabetics.
What attracted you to InsuLife?
Insulin is a well-known molecule that has been used for a hundred years— since 1922, actually— but InsuLife is creating a new way of delivering it. Giving the option of transdermal application could revolutionize insulin use. The technology being used to develop such a product is very enticing.
If we can document that our investigational product is effective and that it is stable for a longer time than current water-soluble insulin products— it has the potential to do so because our spray does not contain any water— we believe we may create two huge new benefits for insulin users: the first one - the biggest one - is avoiding the use of needles for delivering insulin, and the second is having the flexibility to store the product out of a refrigerator over a longer period. We are currently carrying out experiments to study and document stability.
Stability at room temperature may mean that we can avoid cold-chain transport, making logistics simpler and reducing costs. Because our production method is cheaper than most medicinal production lines, it should allow us to sell Levellor at a very competitive price so we can make it available to all the people who need it globally.
Access to insulin is a challenge in many parts of the world. Is InsuLife taking steps to remedy this problem?
We believe that no one will be able to produce insulin preparations in a delivery device at the price that we anticipate for producing the spray, so we aim to make Levellor accessible in developing countries at prices that are affordable. The stability element is also very important in countries where cold-chain transport is more difficult.
Where are you in the clinical development process?
We are ready to start clinical trials now. After discussions with the Norwegian Medicines Agency, we do not need to do further animal trials, but can send in an application for a human clinical trial based on available data.
The plan is to start the first clinical trial this summer, the summer of 2022, that will be conducted at a Norwegian University Hospital. We will first study a small cohort of healthy volunteers and then move on to type 1 diabetes patients.
The point of using type 1 diabetes patients is that we know that they do not produce insulin themselves, so any insulin that we can detect in their blood would have had to come from outside the body. So, if we spray insulin onto their skin and can detect it in the blood of these patients, we can show that it passes through the skin. Measuring their insulin response would show it works, and safety will also be studied.
Are there any additional elements that make Levellor unique?
It is a patented technology, which is inherently unique because no one has been able to deliver insulin through the skin before. Given the size of the molecule it shouldn’t normally be able to pass through the skin. Transdermal Delivery Solutions Corp. has developed a special technology to make this happen, and Insulife has the rights to commercialize this globally. From a patient perspective, we think the two elements of transdermal application and stability will be groundbreaking on their own.
What is your projected growth trajectory?
Our ambition is to complete the clinical development program, apply for marketing authorization and for Levellor to be on the market in 2025. Currently, we are working to get investors on board to be a part of this exciting journey. We believe InsuLife has great potential to increase the company's value during this time. In ten years, we aim to have significant sales throughout the globe, though we first need to obtain marketing authorizations and succeed in the US and Europe to offer it cheaply elsewhere.
Is the strategy to start in the US or Europe?
We are developing our plans for these two markets in parallel, but might launch in the US first because regulations around insulin are slightly different. You can buy insulin over the counter in the US, which is not possible in Europe. We will conduct clinical studies in both Europe and the US, and possibly other parts of the world as well.
What does InsuLife hope to accomplish in 2022?
The goal is to get two clinical studies started, the first being the Norwegian study mentioned and the second being a type 2 diabetes study in the US. Depending on how long these studies will last and how effectively we can recruit patients, we could have results from both studies by very early next year.
This year marks the centennial of insulin, as you mentioned. What innovations do you predict might come about in the next one hundred years?
I think eventually someone will come up with something closer to physiology, whether it's stem cell technologies to make new insulin secreting cells or making an artificial pancreas that works autonomously. Researchers are working on such concepts today.
Some people are also working on insulin monitoring systems that will draw on insulin only when needed. There will be further developments. These developments will focus on those who can afford them. So, in a big world where diabetes is one of the biggest medical problems, I think our investigational medicinal product Levellor could be an important contribution to a better life for persons with diabetes. Not everyone will be able to afford these new sophisticated solutions, whereas our goal is for the spray to be easily accessible.
DISCLAIMER: Levellor is an investigational medicinal product in development that is not approved for use nor available on the market.
