There are two main risks that we face:
The first is under-capitalization. Since we are
deeply committed to the core value of a social mission, we are developing products
that have the potential to impact large populations worldwide. Funding a social
enterprise is a bit more challenging than attracting traditional investments. We
are actively pursuing many funding sources, but the process takes a while to
finalize. You can help us accelerate the process. Initiating clinical trials is our
target milestone, which will significantly lower risk and attract more
investors at this critical stage.
The other major risk to
getting to market is FDA approval. This is greatly reduced because
we aren't developing a new drug. Insulin has been in use for almost a hundred
years, has been studied in hundreds of clinical trials, and has a long safety
and efficacy track record. We just have to show our own formulation is safe for
human use. This gives us the advantage of requiring much less time and
money to get the insulin patch approved, compared to the process for a
totally new drug.
Our development plan accounts for these and other
factors, and breaks up our overall plan into milestones so that we can keep
moving forward, one step at a time. We are raising funds and investing time
only after we have demonstrated success at each stage.
Diabetes is a huge issue and there are many new technologies coming out trying to improve care.
None are so convenient, painless, simple and inexpensive!
More and more patches are being developed, but none can deliver molecules as large as ours.
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FAQ
Why are you qualified and why target diabetes?
Our founder-CEO-CSO is a Harvard-trained clinician, PhD scientist, inventor, and public health expert. His broad and international experience is well suited to pursue development of the insulin patch. Hear it in his own words, and learn more about our team here.
Why is this patch different, and why does it work for insulin delivery where others have failed?
This patch continuously and consistently delivers insulin for up to 7 days. The patch can be replaced at any time with a new one to suit user lifestyle and convenience. Insulin delivery can also be immediately stopped by removing the patch, a great advantage over oral, inhaled, or injected insulin delivery. Our founder has a pretty cool theory on why we were able to do what others couldn’t. The definitive structure of the armor-like outer most barrier of the skin called the stratum corneum (SC), which is the primary barrier to drug delivery, was only determined and published in 2012 by Professor Lars Norlen. We actually didn't really understand how to alter the SC to allow for delivery of large drugs like insulin and even the majority of small chemical drugs. The structure is quite surprising and different than what had been previously adopted. Dr. Hsu developed a formulation that is consistent with this surprising structure of the SC. Check it out below, and then learn how we stack up to other types of insulin delivery methods.
Do you have any preliminary results?
Yes, and they are very exciting! We compared injection (on the left) vs. our patch (on the right) for lowering blood sugar (glucose) into the normal range in rats with type 1 diabetes. What we saw was that the patch had a vastly superior effect on blood glucose levels. When we injected six different animals with the same amount of insulin, the effects ranged from no effect at all to a dangerously low level of blood glucose (hypoglycemia). However, when we applied the patch, there was a very consistent and predictable response. The blood glucose level in all seven animals was lowered into the normal range. This means that less insulin can be used in the patch to predictably and consistently have the same effect every time, and eliminate dangerous variations from injection to injection. These graphs also show that removal of the insulin patch quickly stops the delivery of insulin, which can sometimes be important.
Injection Patch
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Conclusion: the patch consistently lowers glucose levels to the ideal range. Injection is very unpredictable- 6 animals have 6 different results.
How much and how long do you need to get to market?
Our path to market is actually quite inexpensive and rapid, compared to a traditional discovery-to-approval process.
Since insulin is already approved, is known to be safe and effective, and hundreds of clinical trials have already been done, we will file for FDA approval under what’s called a 505(b)2 pathway. We don’t need to repeat extensive studies of insulin absorption, distribution, metabolism, and elimination. We just need to demonstrate that the insulin TruePatchTM is safe (no skin toxicity) and show that it is at least as effective as needle injection. This means that clinical trials will be much shorter and less expensive than for a new drug.
All told, we will need about $75 million- $100 million on a 5 year development path, compared to around $2 BILLION and 12 years to get a completely new drug approved. This will help us to make our products very inexpensive.
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How exactly will funding be used?
The money we are raising through Indiegogo will be used to fund large animal studies that will allow us to apply for FDA trials in humans next year. The animal model we will use is the pig, a standard approach for patch studies since they are very similar to humans in body surface area, weight, and how their endocrine system works. We also have to pay a Contract Research Organization (CRO) to independently validate the safety of the insulin patches. The data from the pig studies will allow us to apply for FDA approval to conduct Phase 1 clinical trials to assess the safety of the insulin TruePatchTM. Some of the funds will also go toward overhead like legal fees, rent, salaries, supplies, and lab equipment to keep us moving forward.
If this is so groundbreaking, why haven’t you gotten more funding?
We are pursuing funding from all sources including grants, private donors and investors, foundations, and industry partnerships. It takes a lot of time to identify and develop relationships and form agreements with all of these sources. Additionally, major funding sources typically get involved only once a treatment has been approved for human trials. In the meantime, we want to move as quickly as we can to ensure that this treatment gets to the market and starts improving lives as quickly as possible. That’s why we are here to ask for your help to accelerate the process of getting our patches into the hands of those who need them.
Has this science been peer-reviewed or published?
We were invited to give a scientific poster presentation this past June at the annual meeting of the American Diabetes Association - which is considered to be a premier event in the academic diabetes community. We have also been invited to give an oral presentation this coming September at the European Society for Pediatric Endocrinology. By the time you read this, we will have just submitted our first manuscript for publication to a premier international peer-reviewed diabetes journal.
Is this patch safe?
Yes, our TruePatchTM delivers the same insulin that has been safely on the market for almost a hundred years. It contains non-toxic and non-irritating ingredients for insulin delivery and patch adhesion. The patch, like a simple bandage, can be immersed in water and stay on, but if it becomes too wet or dirty, it can simply be swapped out and the same dose will continue to be delivered.
Are there other uses for this technology?
As a platform technology, there are many potential uses. So far we have data confirming that we can deliver insulin; human growth hormone; and a compound gel to stimulate hair growth better than leading products.
We are also confident that our insulin patch could be used to treat prediabetes, which affects 86 million Americans, and prevent progression to type 2 diabetes. Insulin therapy, along with diet and exercise, has been shown to reverse prediabetes. But the need to inject daily has been the barrier to prevention in people who are at very high risk. A convenient patch overcomes this barrier and allows growing numbers of people with prediabetes from progressing to type 2 diabetes. Our insulin patch can actually change the natural history of the development of type 2 diabetes.
Further, imagine a convenient once weekly patch that delivers a fixed dose of a combination of drugs to treat depression, so that the patient can actually follow the treatment and get the benefit. How about a patch to prevent or treat blood clots in the leg? Or a combination blood pressure/cholesterol/insulin patch? The possibilities are massive!
Will you have pre-meal/rapid acting insulin?
We have established that we can and will develop pre-meal/rapid-acting insulin patches as soon as we can, but we are focusing on a long-acting basal insulin patch because it is the foundation of all insulin therapy. Time, resource constraints, and regulatory strategy factor into our development plan.
How did Prometheon get its start?
Dr. Hsu invented and patented our company’s patch technology in the spring of 2011. He was determined not to just let his scientific discovery be published in a journal, but to ensure that it’s enormous potential for social impact be fully realized. In August 2012, Prometheon’s efforts as a biotech startup really began. Dr. Hsu was accepted into the University of Florida’s globally ranked #1 Sid Martin Biotechnology Incubator and moved in with his R&D staff. Since then, he has been fully dedicated to creating simple solutions to the world’s biggest health problems. Today, we remain just as committed to our core value of advancing health equity. Learn more about our history.
What traction have you gotten so far?
2011: Strong multinational patents filed
2011: Semi-Finalist, Cade Museum Innovation Prize Contest
2012: Final Four, Cade Museum Innovation Prize Contest
2013: Sid Martin Biotechnology Institute named Best Incubator (National Business Incubation Association)
2014: Invited Scientific Presentation at ADA and ESPE annual meetings, publish manuscripts
2014: Launch crowdfunding campaign for large animal studies (thanks for your help!)
Thank you so much!!
