The following is a conversation between Dr. Giovanni Traverso of Brigham and Women’s Hospital and MIT, and Denver Frederick, Host of The Business of Giving on AM 970 The Answer in New York City.
Denver: Only about 50% of people take medication as prescribed. Some folks on long-term medication, well, they eventually just give up and stop taking it. This non-adherence could cost up to $100 billion a year in the US alone, so this is quite a problem. But with us right now is someone working on the solution. He is Dr. Giovanni Traverso from Brigham and Women’s Hospital and MIT in Boston. Good evening, Doctor!
Giovanni: Good evening! Thank you so much for having me on the show.
One of the things that we recognize, and others have recognized this, is that making it easier for a patient to take their medication really increases the likelihood that someone is going to take their medicine.
Denver: So, tell us about your research to address this problem.
Giovanni: Absolutely. As you highlighted, non-adherence is an incredible problem affecting over 50% of the population and translating into significant cost to the health care system and access actually about $100 billion per year here in the US alone. Aside from the cost are the significant morbidity and mortality that are associated by the simple fact that folks just don’t take their medication. One of the things that we recognize, and others have recognized this, is that making it easier for a patient to take their medication really increases the likelihood that someone is going to take their medicine. So let me give you an example. If a doc prescribes a medication that you have to take four times a day versus taking that same medication once a day, people are more likely to take it once a day than four times a day just because it’s hard to remember to take it four times a day.
Denver: It makes a lot of sense.
Giovanni: Exactly. And actually there are some data out there also supporting that if you extend that a little further, that the likelihood of taking the medication also continues to increase. And so what I’m referring to is going from, for example, a medication that is dosed once a day to once a week and even once a month. There are some medications where you can do that, there’s only a limited number that exists in those formulations. And so, what we set out to do is to try and develop a system that allowed patients to take their medication more infrequently.
Let me just take a step back and tell you sort of a little bit about where we started this work. Several years ago, a team from the Gates Foundation came to visit us in the lab and then subsequently circled back to us with a challenge. They said, “You know, it would be great if we had systems that allowed us to give our patients, for example, in Sub-Saharan Africa, really resource-constrained settings, their full course of treatment in a single-administration event.”
Denver: Like for things like malaria, I would imagine.
Giovanni: Exactly. And you have to sort of put yourself in that situation. And really what you want to make sure is that folks on the ground in these really sort of limited setting have the ability to get the full treatment and the docs and other health care professionals there on the ground will ensure that the patients are dosing themselves correctly just to avoid any complications or antibiotic resistance, et cetera. And so that, working with the Gates Foundation, we actually set out to address this. And so what we did was develop a capsule that can stay in your stomach for a prolonged period of time, and by “prolonged,” I mean a week, two weeks, and perhaps even longer. When you consider a regular capsule, you take a regular capsule, you take it, and just as food, when you eat your food, that would go through your body in about a day.
Denver: Right through the pillories and out it goes.
Giovanni: Exactly. And so similarly, a capsule, typically when you go the pharmacy and you get an extended-release capsule. An extended-release capsule is for 24 hours and that’s really limited by a couple of factors, but one of those is just that our GI tract — our stomach, small intestines and large intestines – they’re actually thoroughly effective at transiting materials through them. And so what we set out to do is really to explore different ways of sort of slowing that down and then allowing essentially a system to really deliver a drug over prolonged period of time.
And so, the way that we did that was by developing a capsule that looks much like a star. The capsule itself looks like any other capsule, but when the shell dissolves in the stomach, out pops out a star that is able to stay in the stomach without causing any obstruction or any symptoms but that little star, the arms of the star, so the spokes of the star, are made of a polymer which is impregnated or loaded with a drug. What happens is then that drug can slowly come out over whatever time frame it is that one needs to receive that medication over.
Denver: So if I get this right, you are warehousing the medicine in the stomach?
Giovanni: That’s exactly right. In order to prevent that star system to essentially be expelled out of the stomach, there’s a couple of things that we had to work out in the lab. One of them was “what’s the best size?” What we know is that the exit of the stomach is about 2 centimeters, so we knew that a star had to be over 2 centimeters when in the stomach. And then the other thing that really is really important is that the stomach is actually a really strong organ and that it helps digest food and it really compresses material in the stomach, so we had to develop some materials to withstand those compressive forces. And then what we built into this system are segment that are capable of dissolving either in the intestine in case it passes inadvertently out of the stomach so that it breaks up and doesn’t cause an obstruction or that can break up over time. And so you have a star that you can control how long it will live or reside in the stomach.
We really want to bring this technology to the patients, and as part of that effort, we actually started a company in 2015 called Lyndra that is really focusing on bringing these technologies to patients and really building out all of the safety parameters and all of the data that’s required by the FDA in order to safely dose human.
Denver: Now, I know that you have so far managed a two-week diffusion but were working on increasing it to a month. How is that going?
Giovanni: It’s going really well. We’ve actually managed to actually keep these stars without any side effects in our pre-clinical models for over a month. And so, I think we’re well on our way. I think it will require more development. We really want to bring this technology to the patients, and as part of that effort, we actually started a company in 2015 called Lyndra that is really focusing on bringing these technologies to patients and really building out all of the safety parameters and all of the data that’s required by the FDA in order to safely dose human.
Denver: That’s fantastic. And I would imagine actually the dosage that people are going to get is going to be even more even than the spikes we get when we take that daily pill or that multi-day pill. Would that be correct?
Giovanni: That’s absolutely right. Now, that’s a great point. Because you have the system in your stomach slowly releasing, it’s exactly as you pointed out. It gives you a much more even dose, constant dose, and so therefore, actually, in some situations, for example, you may need less drugs because you’re able to provide this continuous, steady dose as opposed to the peaks and valleys that you might face when you’re dosing a regular medication. And then I think the other piece to that is that because it’s there for prolonged period of time, any effect that sometimes are seen with food are really significantly removed because it’s there all the time. It’s delivering slowly irrespective of the food and that really, as you highlighted, really provides a much smoother level of drug in the body.
Denver: We mentioned malaria before. Give us a few other things that this might be useful for.
Giovanni: Absolutely. So we’ve been working on HIV and some other neglected tropical diseases. There are some parasitic infections that affect a lot of people, for example in Sub-Saharan Africa. And so a lot of our focus in the lab has been with the Gates Foundation on working on diseases affecting Sub-Saharan Africa and Southeast Asia, for example. But HIV is another big area that we’ve been focusing on and parasitic diseases also. Lyndra is looking at a whole host of different things including psychiatric illness, problems with addiction. So really, I think, there’s a very broad of conditions that can benefit from this system.
Denver: It’s truly a brilliant platform and I know you don’t have a crystal ball predicting what the FDA is going to do, but how soon do you think this might get to market and people on our listening audience might be able to take a pill like this?
Giovanni: That’s a great question. So we’re starting the first in human trials this year and 2017, so as far as being on the market, likely in about three to five years.
Denver: That’s fantastic. Well, this is very exciting and important research with some real practical benefits to just countless people out there. Thanks so much, Doctor, for taking the time to share it with us tonight.
Giovanni: No, thank you so much, Denver, for your interest in really sharing it with your audience.
Denver: I’ll be back with more of The Business of Giving right after this.
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