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Q&A: How Akili plans to make its DTx routine ADHD treatment

unfoldingmatrix by unfoldingmatrix
September 14, 2022
in wellness
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Akili Interactive hit the public markets in August, bringing in cash the company will use to launch its video game digital therapeutic for children with ADHD later this year.

Akili’s product, dubbed EndeavorRx, is prescription software for kids ages 8 to 12 who have attention issues. It received FDA De Novo clearance in 2020 after years waiting for the agency green light, though a nonprescription version was released after some regulatory requirements were relaxed due to the COVID-19 pandemic.

Matt Franklin, who joined Akili as president and chief operating officer early this summer, sat down with MobiHealthNews to discuss the launch strategy for EndeavorRx, its products in development and why going public was the best move for the company.

MobiHealthNews: There’s definitely been a slowdown when it comes to digital health companies going public this year, compared with 2021. Why do you think this was the best route for Akili? 

Matt Franklin: There were two main drivers for us. First was that this event enabled us to get access to financial resources that are going to enable us to accelerate the commercial launch of EndeavorRx, to be able to impact more lives in ADHD. But I think secondly, we’re also thinking about this opportunity long term. Access to the public markets over time gives us access to funding and capital to expand the impact beyond ADHD into other areas, such as multiple sclerosis, major depressive disorder, autism spectrum, and more acute conditions like COVID brain fog.

MHN: So you’re planning on using the proceeds to launch EndeavorRx, which received FDA clearance a couple of years ago. What’s your strategy to launch it? It’s a prescription product, so how will you engage with providers?

Franklin: The first area that we focused on is building our fulfillment or distribution infrastructure. This is an app that can be downloaded from the App Store or from Google Play. But we needed to build a custom proprietary distribution system to be able to validate prescriptions, to be able to collect insurance information, to collect payments and to actually dispense the prescription. 

So that work, I’m happy to say, is complete. We’ve now seen several thousand orders or prescriptions flow through that infrastructure. We’ve seen prescriptions coming in from all 50 states to date, which has really enabled us to focus on the second phase, which is building up our commercial and medical teams to be able to engage with healthcare providers to provide that education, to drive awareness.

Our goal is really to make EndeavorRx a part of routine clinical treatment in ADHD. So that’s where we’re focused. We’ve hired the first wave of field resources. They’ll be on board here in Q4 engaging with providers, and we’ll continue to build out our full national footprint over time.

MHN: Akili also has other products in development. How did you choose those new clinical areas for expansion?

Franklin: EndeavorRx works on cognitive attention function. So we really looked at those indications, those diseases that had attention or inattention implicated. So ADHD, it’s critical, right? That’s one of the critical clinical manifestations. So our near-term focus is on driving awareness and adoption in pediatric ADHD. We’ll look to expand that to adolescent and adult populations.

Beyond that, autism spectrum disorder also has a high degree of overlap with attention and cognitive function issues. So that’s an area of expansion. Multiple sclerosis and major depressive disorder are areas that we’ve already studied. And we’ll continue to execute additional confirmatory studies there as well.

MHN: What do you think are the next steps to expand the use of digital therapeutics? 

Franklin: I think we have a near-term opportunity to educate on the different classes or categories within digital therapeutics. For example, EndeavorRx fits in this prescription digital therapeutic category. It is prescription medication delivered in this engaging entertainment format.

Second, we’re driving awareness of our clinical data. One of the things that attracted me to Akili was the strong scientific underpinnings, but also the rigorous clinical evidence. So there is not widespread awareness of the clinical data that supports an approach like EndeavorRx. So we are actively engaged in driving awareness of that strong supporting clinical evidence as well.



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