Treating Chronic Conditions Via Long-Acting Implants With Vivani's Adam Mendelsohn
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The popular GLP-1 agonists employed in treating obesity and Type 2 diabetes are commonly administered via weekly injections. In this episode of Sit and Deliver, host Tom von Gunden talks with CEO Adam Mendelsohn of Vivani Medical about enhancing patient adherence and convenience via long-acting, controlled release implants delivering medications for chronic conditions.
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Episode Transcript
Tom von Gunden, Chief Editor, Drug Delivery Leader:
Welcome to another episode of Sit and Deliver. My name is Tom von Gunden, Chief Editor at Drug Delivery Leader and your host for the series. Today I am joined by Adam Mendelsohn, CEO at Vivani Medical, a company which is working on developing ultra-long-acting drug implants targeting chronic diseases.
Welcome, Adam.
Adam Mendelsohn, CEO, Vivani Medical:
Tom, thank you very much for having me. I'm excited to be here.
Well, it's our pleasure to have you here. So, thanks for joining.
Let's start by talking about the initial patient population and therapeutic areas that you're targeting there. And that is, folks who are suffering from Type 2 diabetes or have issues with obesity. And so, I know that you're working on implants to deliver GLP-1 agonists to those patients.
So, can you tell us a little bit about, historically or even currently, what that experience has been like for patients. What options have been there for them for treatments and how has that gone for them, typically?
So, for patients with Type 2 diabetes, which is where the GLP-1 agonist class had its start, there have been a number of available options, from certain daily pills to the weekly, injectable GLP-1 agonists that have really transformed the space and provided remarkable efficacy, particularly in clinical trial settings.
And for patients with obesity, it was when the industry started evaluating higher doses of the GLP-1 agonists that were first indicated for the treatment of Type 2 diabetes, that really extraordinary weight loss effects were observed. And this has led to some of the blockbuster products that people take really to a high degree. But these are all weekly injectables, currently.
And with over a billion people in the world suffering from obesity, there really is an incredible opportunity for this new, relatively new, drug class to make a big impact on the real-world health outcomes for these patients. But these drugs are being held back by only about half of people taking them as prescribed in the real world. There are a number of reasons for this medication-nonadherence phenomenon, but it's very widespread.
And this is what motivated us to think about an implant approach that a patient could receive in a setting where they are already visiting their physician to monitor their care and have assurance that they will get the medicine that they need in-between appointments. And we're excited about the opportunity to hopefully bend the curve in the real world for patients with these diseases.
All right. Great. Well, thanks for the detail on the current landscape. So, I know that you're working on implant-based approaches. And, perhaps, especially from a patient adoption standpoint, that might seem obvious why you would move away from injectables. But can you tell us a little bit more about the options out there that you looked at and why the company, why Vivani, has moved forward with working through implant-based approaches?
So, when we looked at two different areas, one is the poor medication adherence that I mentioned earlier to the currently available treatments. And then we also looked at other products that are in the implant space that have demonstrated the ability to achieve meaningful adoption. There's a contraception implant that is used relatively widely. That demonstrated to us the willingness for people that want the convenience to be able to undergo a very small procedure that would enable them to really forget that they have the disease over the duration of the implant, not have to remember to take their medicine.
In addition to, what we think will be a compelling reason for another group of people to consider an implant, which is them not really getting the health benefits that their physician believes that they should, based on the drug that they have been prescribed. That an implant, which we think will do a better job at improving medication adherence, will enable people to get healthier.
So, the real idea here is how can we get people healthier in a sustainable manner, with requiring less input from them, trying to eliminate the human element as much as possible and really allow the drug to do what it has been demonstrated that it can do?
All right. Great. Well, let's dig a little deeper, no pun intended, really, when we're talking about implants. But since we are talking about implants, can you tell us a little bit about the procedure, the frequency, the regimen, and then a little bit more about the mechanism of action. What actually happens when that implant is in a patient's body? How does it get there, and what does it do?
Yep. So, I'll start with the frequency. We're targeting once- or twice-yearly implants. The first implant that is in development is designed to be a twice-yearly implant. So, once every six months. The reason for this interval is, in part, because it aligns with [the] frequency, over which many of these patients should or do see their physician to receive care and to monitor their progress. And by leveraging the visit that those patients and their caregivers are hopefully ensuring that they attend, we think we can minimize the inconvenience to the patient to receive the product.
Now, once they go to their appointment, then the implant could be administered through some local anesthetic. It is loaded into a tool, that we call an applicator, that creates a pocket and places the implant under the skin. In our first clinical study, it's going in the outer upper arm, the same location as the commercial, implantable glucose sensor in a similar patient population.
And once the pocket is created, the needle that holds the implant is retracted. The applicator is lifted off the skin once the implant is inserted. No stitch is expected to be required. A butterfly bandage can be placed over the site of insertion and can be accomplished in just a short number of minutes.
So, the idea to tack it onto a visit that someone would already undergo, we think will help provide convenience and then allow the patient and their caregivers to not have to be concerned about the patient taking their medicine in between appointments.
Gotcha. Is there anything unique or special or descriptive about the mechanism of action itself? What happens once that implant is in the body?
So, once the implant is placed, there is a reservoir that contains a high concentration formulation of the drug. And there's a material that controls the release of that drug such that it is a substantially constant, very steady and continuous release of the medicine over the duration of the implant.
The material is what we started this company around. It's an array of titanium oxide nanotubes, but it's designed to have openings that are close in size to the individual drug molecules. And ultimately, the way it works is it controls the release. And it's a very smooth release profile, which we think is important for GLP-1 agonists because a lot of the gastrointestinal side effects, which are the number one complaint that people have associated with these products, are associated with rapid changes in drug levels, rapid increases in drug levels.
So, by having a product that provides a very smooth profile, we are going to look for signals of tolerability in the clinical program that we are currently conducting. But we're hopeful that we will be able to provide an adequately tolerable treatment that may have some advantages over the other products that require more frequent administration.
Gotcha. So, in your description of the rationale for the approach — perhaps in many ways you've already outlined the hope for the results — but is there anything else you'd like to say or can imagine when you look out over the horizon, and if these advancements take hold and have effect, what changes these will make?
What I haven't touched on yet is the consequences associated with the current state of poor medication adherence and the costs that are associated with those consequences. In the case of people with Type 2 diabetes, it has been measured that there are about $5,500 in avoidable costs associated with nonadherence to Type 2 diabetes medication. People that go to the hospital or have extra doctor's visits that could have been avoided if only they had received their medicine. So, in addition to being healthier, we think we may be able to have an impact on payers and potentially also on copays for patients on the cost of the treatment.
But overall, this is a really significant challenge, not just with Type 2 diabetes and obesity, but across the disease spectrums. But with the effectiveness of GLP-1 treatments and the clear opportunity to improve health outcomes and costs for this particular drug class, we remain highly motivated to continue to develop our products.
That's great. All sounds very promising.
So, for the last question for you today, Adam, I want to also look out over the horizon and look at potential other patient needs or therapeutic areas or indications that this technology and approach might address.
So, as we think about a product like ours, we want to find an application where continuous delivery of a medicine will be helpful, where there are drugs that are adequately potent such that a clinically meaningful duration can be provided from a single implant that's not going to be too large for the patients to accept.
And when we think about the confluence of those attributes, there are a number of disease areas that come to mind. But I have to say that the applications that we think may be available, even just within the GLP-1 agonist space, are so numerous and so compelling that, right now, in addition to Type 2 diabetes and obesity, we're following the progress of evaluating GLP-1 drugs in Alzheimer's and Parkinson's, as an example, if you can imagine that. To the extent these are shown to be effective, which we don't know yet, but there is a Phase 3 trial going on right now, the opportunity for an implant in an Alzheimer's disease patient setting should be pretty obvious. As well as all of the other diseases of aging and longevity and metabolic diseases like MASH [Metabolic Dysfunction-Associated Steatohepatitis] that are also associated with metabolic syndrome. That's where we're focused.
But there are areas outside of what GLP-1s may be capable of that we think the platform, our drug delivery technology that we're working on, may be able to be applicable. And for those we look to identify adequately potent drug molecules that would enable our technology to work in those settings.
As I mentioned before, it all sounds very promising. I want to thank you, Adam, for joining us today for this episode to share the work that's being done there at Vivani Medical and your perspectives on the market [and] in the patient population out there. And I also want to thank our audience for joining us for another episode of Sit and Deliver. And we'll see you next time.