Will the FDA give the go-ahead to a prescription video game? - STAT

SAN FRANCISCO — In mid-2018, the startup Akili Interactive Labs asked the Food and Drug Administration to let it do something that’s never been done before: market a video game that physicians would prescribe to kids with ADHD.

A year and a half later, that green light has yet to materialize. It’s unclear whether that’s a sign of trouble — the company wouldn’t say whether the agency has asked it to make changes or run a new study — or simply a reflection of the complexity of evaluating a medical product without precedent.

Akili’s CEO, Eddie Martucci, told STAT the company is having ongoing discussions with regulators. He said Akili believes it has studied its game rigorously, and that the data speak for themselves.

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Asked if he felt disappointed that the regulatory go-ahead hasn’t come sooner, Martucci conceded: “The process is obviously longer than some of us had hoped, I can say that much. And any disappointment is more that we’re not yet getting a product to ADHD families that they really need.”

Akili’s video game is played on a tablet. It sends players through landscapes like a molten lava river and an icy winter snowscape, rewarding them with stars and points as they finish tasks. Akili sees the video game as the delivery system for targeted algorithms that can activate certain neural networks in the brain. It’s very different, and much more ambitious, than the many digital health apps and software programs that aim to help patients manage medical conditions by providing education, tips, and reminders.

Akili has said that once its product gets the go-ahead from regulators, it intends to run its U.S. commercialization operation in-house, rather than partnering with a drug company. That’s still the plan. But in recent months, Akili has been rethinking elements of that strategy, STAT has learned.

In late spring of last year, Akili laid off “a handful” of employees, some of whom were working on the commercialization team developing a plan about how to market the product, Martucci confirmed. The company still maintains part of that commercial team, and is growing: Akili now employs over 80 people overall, nearly double its headcount when it filed with the FDA in mid-2018.

The layoffs within the commercialization team reflected a need for different expertise as the company shifted its strategy, Martucci said.

“Our first strategy was, candidly, very pharma-style and pharma-centric — and we’ve evolved … and think this needs to have a lot more of a technology component — a software, consumer component — in terms of how commercial’s done,” Martucci said.

New data and new questions

In ADHD, there’s “great demand for non-pharmacological interventions,” said Sandra Loo, an ADHD specialist at the University of California, Los Angeles, who has no affiliation with Akili. “A product that can help to remediate cognitive issues that children with ADHD are experiencing would be, I think, very helpful and popular with families.”

About five years ago, clinicians and parents had high hopes that several cognitive training programs, including those from direct-to-consumer companies Cogmed and Lumosity, would be useful for ADHD. But they “didn’t really pan out,” Loo said, and so “people have looked in other directions.”

Akili, which is privately held and has offices in Boston and the San Francisco Bay Area, built its game from technology licensed from the lab of Dr. Adam Gazzaley, a neuroscientist at the University of California, San Francisco.

The company’s filing with the FDA is centered around the results of a study testing its game in 348 children between the ages of 8 and 12 diagnosed with ADHD. They were randomly assigned to either play Akili’s game or a Scrabble-esque game in which users connected letters on a grid to spell out words. After four weeks, the group that played Akili’s game saw statistically significant improvement on a computerized test measuring attention and inhibitory control compared to the group assigned to play the sham.

There were caveats, however: The group that played Akili’s game didn’t see as much improvement on that test as some researchers would have liked to see.

There were also questions about several of the study’s secondary endpoints — goals for which the trial was not powered to assess but which are still looked at carefully by researchers and regulators. These were the results of questionnaires in which parents were asked to subjectively assess their child’s levels of attention, hyperactivity and impulsivity.

The good news for the company was that the parents of children assigned to Akili’s game perceived statistically significant improvements in their behavior. The bad news was that the parents of children assigned to the sham game did too — meaning that there was no meaningful differentiation on these metrics based on whether kids were playing Akili’s game or the sham.

By using the sham game as a control — a more rigorous way of running the trial than other designs the company could have picked — Akili may have set itself up for disappointment. That’s because the sham was more fun and enjoyable than Akili’s game, which is designed to be challenging to achieve its intended therapeutic effect. Parents may have picked up on their child’s frustration while playing Akili’s game, while the other group of parents may have been swayed by seeing their child have a good time playing the sham — independent of any therapeutic effect.

Akili is seeking authorization to market its game under the de novo pathway — meant for relatively safe medical devices and software without precedent. Martucci won’t disclose the precise indication the company is pursuing with the FDA, but it’s likely to be relatively narrow. “We’re not trying to say we treat all of ADHD. That’s not how our product works,” Martucci said. “Our target is attention impairments and related cognitive issues in ADHD.”

Loo said she expects that if Akili’s game comes to market, it will be prescribed using a precision medicine approach to only those patients likely to benefit, rather than to all kids with ADHD. “You really have to parse who would need this kind of intervention versus who does not — and try to have measures or some way to assess who is going to potentially respond,” she said.

Akili last week announced the results of another clinical trial it conducted last year. The new study had been planned long before the company submitted its filing with the FDA.

Its goal, according to Martucci: “To answer some of the biggest questions that lead to medical stakeholders’ — like doctors and parents — understanding of exactly how to use our product on the market.” For example: Can kids play the game while taking ADHD medication? And what happens if you play the game for longer than a month?

The study enrolled 206 kids with ADHD, all of whom were assigned to play Akili’s game. They were divided into two groups: those who were taking ADHD medications, and those who were not.

The study evaluated the game using one of the parent questionnaires — the ADHD Impairment Rating Scale — that had been assessed as a secondary endpoint in the earlier trial and can be influenced by factors beyond how well the game works.

On that subjective rating, kids saw roughly equal improvements whether or not they were taking ADHD medication. And they saw additional improvements when they played the game for a second month.

Asked whether Akili would take the new study results to the FDA to augment its filing to regulators, Martucci said the company “certainly could” as part of the process. “Any clinical data we generate, we want to share with all stakeholders,” he said.

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https://www.statnews.com/2020/01/21/will-the-fda-give-the-go-ahead-to-a-prescription-video-game-the-wait-goes-on-as-new-data-come-in/

2020-01-21 10:06:07Z
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