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What the Clearance of Akili’s EndeavorRX Means for the Company, Users and the Industry

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Transcript:

Edie Martucci 00:04 When someone starts our treatment, we know the second they started our treatment. And we scrape 30 frames a second data from our treatment, we have all of that in our database. So after a few days’ session, we have something like 900,000 data points now that’s ridiculous, right? It’s not like we use 98% of those data. But we are starting to make the products better.

Dan Kendall 00:28 Welcome back to digital health today, the place to be to get the insights of leaders making the healthcare of tomorrow available today. I’m your host, Dan Kendall. You know, I love it when health technology is featured in the mainstream press, and if you’ve been tuned into nearly any channel recently, you’ve probably seen the announcement by Akili Interactive Labs about the clearance they announced on June 15 for their product EndeavourRX. EndeavourRX is the first prescription treatment delivered through a video game which is designed to treat pediatric ADHD. Like many of you, I’ve been tracking the work in progress of Akili for a long time, so I was really excited to hear about them achieving this really important milestone. And when the Akili team contacted me to see if I wanted to have a closer look at and even try Endeavor Rx, I couldn’t resist. I’ve downloaded it to my iPad, and I gave it a try. And I have to say, I’m impressed. Now I can’t speak to the clinical side of the product. But they have done a clinical study that was published in The Lancet, we’ll have a link to that in the show notes. But I can’t say that based on the standards and expectations that we have from consumer focused products. This was a great experience. It’s well designed, it has easy onboarding, and it uses a great combination of graphics and sounds. And I love the way they’re sort of positioning it with a tagline: play your medicine, that sort of sums it all up.

Dan Kendall 01:42 To learn more about the importance of this milestone and go a little deeper Behind the Headlines. I grabbed a few minutes to connect with Edie Martucci, the Co-founder and CEO at Akili Interactive Labs, the previous time that Eddie and I spoke was at the CNS Summit in Boca Raton, Florida at the end of 2019. So when we connected, we obviously caught up about the unexpected challenges of 2020. And how both Eddie and I in our roles as fathers are really working to raise our children so that can help make the world a better place. Eddie has three sons, I have two daughters. And we talked about how we’re preparing them to put the current events and sort of age appropriate context, and how we can help our children to become part of the solutions that are really needed around the world. Now, unfortunately, I didn’t record any of that part of the conversation, I was really disappointed because Eddie laid down some real gems and thoughts that showed that he’s not only a great entrepreneur, but also a very thoughtful and dedicated parent and just generally a great person. He did offer to come back and talk about parenting sometime, but I think we’ll have to save that for another podcast series. Maybe we’ll come up with something like Digital Health parents and show another side of the people who are working to change health and care. Now we did eventually get onto the topic of EndeavourRx, and I did hit record for that part of the conversation. You can find links to the app, the press release, the study in The Lancet, and other details in the show notes for this episode, so please just scroll down to see that or you can visit our website at DigitalHealthToday.com/podcast, and also a reminder that you can find our episodes and thousands of other episodes created by talented health podcast creators. At our second home, which is Health Podcast Network, you can get there by visiting HealthPodcastNetwork.com. That site has new shows in a wide range of topics every day, so please do check that out. And subscribe to the newsletter there too. Now let’s jump into the conversation with Eddie Martucci, CEO and co-founder of Akili Interactive Labs. Eddie, thanks for joining me. Welcome to the program.

Eddie Martucci 03:35 Thanks so much Dan.

Dan Kendall 03:37 Eddie, I want to jump right into it. Akili is in the headlines a lot right now as a company, you focus on cognitive function. And some people know Akili as the company that makes games. I’ve heard you describe Akili as a digital medicine company that focuses on cognitive function. Tell us in your words, what is Akili does and what are you working to achieve?

Eddie Martucci 03:58 Sure, thanks for that. Yeah, we’ve been fortunate to have a number of milestones recently, everyone, of course gets excited about the fact that our treatments were delivered through a video game. So no surprises are nothing new that grabs headlines. We really founded this company to make a new type of medicine, a new type of medical product that was actually capitalizing on brand new innovative research of how to activate the brain. So how to tap into brain function, which we believe is a kind of left behind or a never fully addressed area of medicine. But, to marry that with the very best of technology so that you could experience medicine in a brand new way something that’s targeted, something that is not delivered by ingesting it, but it’s actually delivered through the very screens and devices that use for your entertainment and in the moment might even feel like entertainment. So we make digital treatments, we do say digital medicine but digital treatments that are aimed at directly impacting cognitive networks in the brain with the goal of having treatment effects are very targeted for specific cognitive impairments. And then we deliver those and hopefully exciting experiences like video games.

Dan Kendall 05:09 So you use the word digital medicine there. And I want to give the audience a chance to understand the difference between digital medicine or digital therapeutics. And if there is a difference. I know there’s a lot of banter. And I don’t want to go really deep into this, but just to make sure that we have a bit of a context, from your perspective, as an organization is out there interfacing with regulators, with the commercial environment, with the scientific community. What does digital medicine and digital therapeutics, what do those terms mean?

Eddie Martucci 05:35 Sure. And you’re absolutely right, there’s a lot of debate or cloudiness around the difference of these terms. And some people still ask what’s the difference between digital health and digital therapeutics, so there’s a lot of confusion out there. From my perspective, digital therapeutics are delivering a treatment of some type or an intervention, I should say of some type that is meant to improve healthcare, that’s meant to improve outcomes. And so there’s lots of different types of digital therapeutics out there. When we talk about digital medicine at Akili, we mean two things, we mean our digital therapeutics have gone all the way through the process of validating a prescription model through an FDA regulatory clearance so that they can be truly used in mainstream medical practice. And so that’s what we’ve just done with our pediatric ADHD treatment that’s focused on attention, function and children. And so this is for us very important. It’s saying that not only can something have clinical outcomes, it can actually be practiced in medicine by doctors, because it’s prescribable. So that’s very important. The other sort of nuance that I like to include in there is one of the other reasons we use the phrase digital medicine, is we really do view the future of care as more holistic than a single point solution. Or the one thing that the patient’s taking to get better. We think one of the benefits of digital is you can engage the patient, the caregiver, you can use data to feed back to them and understand. So our digital treatments are commercialized through not only the treatment that’s in the child’s hand for ADHD, but actually applications sitting in the hands of the parents, or caregivers and patients support services that are coalescing all those data and helping pull the patient through. So it’s really a brand new type of care paradigm in medicine.

Dan Kendall 07:26 You’ve mentioned your new product that’s been approved for pediatric ADHD. And you’re also working in the areas of MS and major depression and a few other areas. But let’s talk about this announcement. So the product is Endeavor Rx, and it was just approved by the FDA. It requires a prescription, is designed for children ages eight to 12 with certain symptoms of ADHD, what does this mean for the US, to the healthcare environment, to the individuals who will be using this and to the healthcare system broadly?

Edie Martucci 07:58 Yes, and you got everything right there. And that’s accurate to my knowledge in terms of EndeavorRx, obviously, the label is specific and matters. We think this means a couple things. I mean, the number one thing that’s in my head, and why I’m so excited about this is we’ve been working for years to bring this treatment to patients who can benefit from it. But we put up our own barrier, which is doing extensive clinical trials, like any other medicine, like you’d expect from other medicines. So at this point, we had done five clinical trials, over 600 children in ADHD, multiple randomized control trials. So our interaction with patients and the way we can help them has been through these trials they gave of their time and energy. What this means is that we now have many, many patients in the world who have struggled specifically with attention issues. This is something that hasn’t been focused on as much in some of these behavioral disorders. They struggle with this cognitive function. And there’s now a treatment available for them specifically to address the attention function. So it’s a big deal. It’s a big day for us to be able to tell people this is what we’ve been working on. This is why it’s taken so long, but it’s worth it. So we’re just so proud and excited and humbled to be able to bring that to patients. I think your question is right, and implying that this means something bigger and certainly does to us at Akili as a business. When we got into this and in some ways helped found this field of digital therapeutics, we got enamored of the fact that you can use technology in one of two ways you can use technology to take what we already have in a healthcare practice today and digitize it. And there’s now a lot of examples of that. I think that’s really taken off in digital health over the last five to 10 years. We’ve always been excited and what we think is the next wave which is using digital to deliver something that you never could have before digital or using technology to interact with human physiology in a brand new way. And I think we had concerns or hesitations of could this model ever truly work. A lot of people have reflected to us that it’s inspiring and exciting, but there’s skepticism of whether you can really take something that’s new that interacts with human physiology, and is delivered in an entertainment style interface and truly get it all the way to become a prescribed mobile product. So I believe what we’ll see is that this opens the mind a little bit and perhaps opens some avenues for a lot of approaches, hopefully well beyond Akili, that are going to now feel emboldened to experiment with technology and healthcare in brand new ways.

Dan Kendall 10:28 You’ve certainly made it to a significant milestone, do you have the sense that the race is really just beginning, that this is really the start of a real work of making the product and the company and the industry adapt and evolve into new ways to make this successful? Not just in a group of 600 children, but also on a commercial basis that can really transform the way things are going forward?

Eddie Martucci 10:52 Oh, absolutely. This is a big milestone, but it’s absolutely not the finish line. We at Akili are now within, you know a business day of this milestone, we’re back heads down, and how can we make this successful? How can we help as many people as humanly possible. And the truth is, unlike traditional medication today, there’s a lot of nuances that still need to be figured out with digital interventions, right? You’re talking about many more touch points, with patients with families, you’re talking about something that’s interactive, where people have to it’s a bigger commitment, it’s in some ways, much more difficult to commit to and harder to stick with than traditional medication because there’s actually interaction and time involved. So we view all of these as opportunities. But the flip side is they’re absolutely challenges that need to be overcome. So this is a, I guess, the end of one mini race in the beginning of another, which is, you know, how do we optimize this on the market. And I think what we and other companies will learn is, you know, we’ll take a couple steps forward and a step back as we learn and adapt. This is, in many ways, the early days of the new medicine industry forming.

Dan Kendall 12:03 So you’ve now launched a product. I know you announced last year in 2019, that you’re building an end to end distribution platform, I think I’ve characterized that correctly, you’ve been really vocal about the fact that the business model for digital medicine isn’t really fully defined. That’s a very candid and honest assessment of where we are. Now you have a product, I presume you have some sort of sales model, sales team, what are you guys doing to actually get this out there and work with clinicians, but also uniquely worked directly with patients in getting this used and accepted and prescribed?

Eddie Martucci 12:37 Yep, yep. And nothing has changed from those statements. So we still continue to believe that with a brand new type of business model, we want to own it, and we want to control it. And we want to have the flexibility to adapt and learn and improve it over time. So that’s some of the tenets of what we wanted to build here, it takes a lot more investment, honestly, it’s a lot harder work. But we think it’s worth it in the long run, so that we can actually learn and adapt. So we are still building that system. We’re collaborating with certain vendors in terms of the whole prescription processing. But we are touching both the doctors and the medical system, we’re already engaging with hcps, and physician offices and clinics, and we’re engaging directly with patients themselves. So this is something that is new, I think jury’s still out on whether this model is efficient, I think you’re seeing a lot of traditional hub businesses are starting to adapt and evolve their business to be able to accommodate the future of digital medicine. So we’ll see where this goes in the long run. But in the short run, we still think it’s important to invest in it ourselves, so that we can optimize in the early days.

Dan Kendall 13:47 You alluded to it earlier about the fact that, you know, in prescription models, typically you work with clinicians, the clinicians prescribe medications, and patients use it, hopefully they use it. Most of medicines are more effective when you actually use them. And your solution is very different. You’re able to engage directly with the user of your product, and you’re not able to just tell if they’re using it, but you’re also able to tell when they used it, how they used it, how well they performed and they use it. What does that mean for the industry and also for your company, as you sort of change and innovate on that feedback loop that you have directly with your users?

Eddie Martucci 14:23 Yeah, I think it’s it means everything. It’s one of the most important yet least talked about benefits in the future of digital medicine, or digital therapeutics. We have the ability to capture the types of data that goes so far beyond the gaps today. I think you alluded to it great. My favorite example is when you look at the difference of the type of data you can collect with, you know, medication and behavioral disorders today to your point, you know, if someone filled a prescription, and that’s it, and you might ask them a couple months later, hey, how’d that go? So, that’s one end of the spectrum. What we do today is when someone starts our treatment, we know the second they started our treatment and we scraped 30 frames a second data from our treatment, we have all of that in our database. So, you know, someone tabulated this at one point for us, like, after a few days session, we have something like 900,000 data points. Now that’s ridiculous, right? That’s, at this point, it’s not like we use 98% of those data. But we are starting to, to make the products better, we’re starting to learn things like our data science team is mining the exact use and play patterns that predict benefit, so that we can do things like understand which patients are playing in a way that’s most likely to have them benefit.

Eddie Martucci 15:39 And prime patients that, for instance, are not playing in a certain way to either take a break, or maybe notify us to have a direct one to one conversation with the patient to help them use the treatment better. So these are examples where the rich data that you can get from digital, you know, as long as you’re doing it on the up and up with the right security protocols, and patient consent, can be used to actually evolve the medicine in a way that we haven’t had before. It’s so much more than just knowing something about how your how your patient is using it, you know, so that you can keep them in the funnel, quote unquote, and monetize them. It’s all about how do we just adapt for every individual patient, and then for every future group of patients, by learning so much more about our treatment. And in that way, it of course sounds and feels a lot more like a technology product. The hope here would be if we use data like tech companies today, but use it for good, which is to say, try to optimize the benefits that individuals are getting, then you’re actually taking the you know, the last few decades of tech research and applying it in this case for the right reasons.

Dan Kendall 16:47 Really powerful stuff Eddie, and I just have a couple more questions for you, then I’ll let you get on with your day. You’re based in Boston. And this is big news with the FDA approval for the US market. But I know you actually look East initially and you’re still working in partnership with organizations in Asia. So can you tell us a little bit about your corporate strategy? And has this product this Endeavor RX is this already been in use in other parts of the world?

Eddie Martucci 17:12 Yeah, so we have a partnership with Shionogi, which is a large pharmaceutical company in Southeast Asia, they’re in Japan, and they serve Southeast Asia, we have a partnership to advance our endeavour product for ADHD and for pediatric autism, in Japan and Taiwan. And so it’s a collaborative work where Shionogi is spearheading the clinical development. So that has just begun in Japan, which is very exciting. And so we’ve kind of localize the product and have a version of both the treatment and the and the sham, the placebo, which is kind of interesting, then both of those are into trial. Now that’s just kicking off, which is really exciting. We also just announced this week that we have received the CE mark approval for European Union marketing of our prescription treatment endeavor for ADHD. So we’re laying the foundation is how I would describe it. You know, we’re still a small company, our eyes are big, as we look at the potential world of people who could benefit, we’re going to be focusing in the coming months and really the US market and making sure we deliver on kind of our first market launch. But we we didn’t want to serialize everything in terms of global expansion. And so we’ve set up some of the initial pieces to allow us in parallel to at least start to knock off the milestones or develop a foothold across the world. The interesting thing about cognitive function is most of the research will tell you there is really no difference across cultures, geographies, or countries, the cognitive issues that persist, persist that at roughly the same prevalence in every single culture. So the opportunity is very large, there are really no directed cognitive treatments anywhere out there. So we feel a responsibility and obligation and a business opportunity to go after that. But it will be in steps.

Dan Kendall 18:59 So you mentioned you’re a small company, you’re working globally, you’ve just gotten across this milestone in the US, how does the US process and the processes in the US ecosystem broadly compared to the validation and the commercialization that you’ve experienced in other parts of the world? And are there things that some of the various stakeholders and healthcare in different parts of the world can learn from one another to make this better for companies like yours?

Eddie Martucci 19:24 It’s a good question. So and to be very clear, we haven’t commercialized anywhere in US yet. We’re still doing those milestones as commercial prep. It’s a good question. I think that what I’m seeing is that regulatory authorities are in fact asking and looking at each other. And that’s a really good thing. So they’re not seeing isolationism. I’m seeing bodies kind of want to see the corpus of data and want to understand how other authorities are looking at this. I think we’ve seen more of this in digital than we’ve seen, quite frankly, and in other areas of medicine, just because it’s so new and it’s evolving so quickly. So That’s a really good signal. I don’t see a lot of like major conflicting work, I just see the pace being different in different territories. So I think that’s probably what’s most similar. What’s most different, I think, is that different countries, especially the payer systems, are just in radically different places, and how they believe that new treatments can impact patient population. So there’s a lot of biases in terms of what medicine should look like. And what I think I’m starting to see is a lot of that chipped away, where more and more payers, whether it be private payers, whether it be national systems are really starting to deeply look and interrogate the data, and the data underlying the products independent of what the products look like. And that’s a really good change and shift in the last few years. So I think the momentum is there. And I hope that with our announcement and other companies bringing products to market that will continue.

Dan Kendall 20:51 Eddie, listen, that’s the really great news. Thanks very much for sharing what’s happening with digital medicine broadly and with Akili. Specifically, congratulations on achieving this milestone, we look forward to hearing the continued success of you and your team.

Eddie Martucci 21:05 Thanks so much, Dan. Really appreciate it.

Dan Kendall 21:08 Thanks for tuning in to another episode of Digital Health Today. Remember to scroll down in your podcast app for the links to the EndeavourRX app, the study in The Lancet, the press release by Akili and much more. All that information is in the show notes of this episode and on our website at DigitalHealthToday.com/podcast. Don’t forget you can also find this episode as well as thousands of other great episodes by trusted health podcasters on HealthPodcastNetwork.com. But no matter where you find us, be sure to subscribe to both the podcast and the newsletter to be kept up to date on the latest episodes, news and announcements. This has been another episode of Digital Health Today, a production of Mission Based Media, original music and audio engineering for this episode was by Ivan Yuric. I’m Dan Kendall and I’ve been your host. Thanks so much for tuning in and until next time, keep on innovating.
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