Akili’s video game digital treatment shows promise in ADHD, eyes FDA approval

pharmafile | December 4, 2017 | News story | Research and Development, Sales and Marketing ADHD, AKL-T01, Akili, FDA, pharma, video game 

Akili, an unlisted affiliate of London-listed PureTech Health, has unveiled top-line results of AKL-T01, a novel digital medicine which takes the form of a video game, in the treatment of paediatric attention deficit hyperactivity disorder (ADHD).

The trial results showed a “statistically significant improvement” compared to an active control (which was also a video game), as monitored by a change in the Attention Performative Index (APL), a composite score from the Test of Variables of Attention (TOVA).

The randomised controlled trial was conducted across 20 sites and comprised 348 paediatric or adolescent ADHD patients, each of whom were evaluated before and after at-home treatment with Akili’s product or the active control. Participants showed no benefit from the active control.

AKL-T01 is built on the company’s Project: EVO technology platform, which works by enabling “selective targeting and activation of specific cognitive neural systems in the brain that exhibit deficiencies from various medical conditions”. In particular Akili’s video game treatment utilises adaptive algorithms which present stimuli that target and engage systems in the prefrontal cortex, the part of the brain known to influence cognitive control which is deficient in ADHD. The platform has all the hallmarks of a high-end video game, and utilises reward cycles to keep patients compliant, delivering a personalised experience by adapting to the needs of each user.

“This innovative study represents, to my knowledge, the largest and most rigorous evaluation of a digital medicine,” said Dr Scott Kollins, Professor of Psychiatry, Director of the ADHD Program at Duke University School of Medicine and principal investigator for the study. “The objective improvements of attention observed in the study suggest that AKL-T01 addresses a key deficiency in ADHD that is not directly targeted by standard treatments. Since the active control group in this study also played an engaging video game, we are encouraged that the statistically significant group differences were driven by the therapeutically active component in AKL-T01 and not just the video game experience.”

Eddie Martucci, Akili’s president and CEO also commented on the release of the data: “This is an exciting milestone for our company, for the digital therapeutic community, and for families and children affected by ADHD. We look forward to advancing AKL-T01 through our planned regulatory process and toward the market.

“The study results further validate Akili’s technology platform as we continue to advance our pipeline of digital treatments targeting cognitive dysfunction in ADHD and other patient populations, and work toward our vision of re-defining medicine.”

Akili will present full results of the study at an upcoming conference, and now plans to file for regulatory approval with the FDA in the first half of 2018.

Matt Fellows

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