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Akili Grabs $55M, Seeking FDA Approval of First Video Game Therapy

Xconomy Boston — 

[Corrected 5/9/18, 9:59 am. See below.] Akili Interactive Labs has scooped up another pile of cash to help bring its first product to the market: an experimental mobile video game aimed at assessing and treating attention deficit hyperactivity disorder.

Boston-based Akili said Wednesday it closed a $55 million Series C funding round led by Singapore-based Temasek. Other investors in the round included Baillie Gifford, Amgen Ventures, Merck’s M Ventures, JAZZ Venture Partners, Canepa Advanced Healthcare Fund, and Brooklands Capital Strategies. The cash infusion follows Akili’s $42.4 million Series B round almost two years ago.

Akili is restocking its war chest in anticipation of filing for FDA approval to begin selling AKL-T01, its video game designed as a digital medicine for ADHD. In December, Akili announced that a 348-patient pivotal trial of AKL-T01 hit its main goal, as children and adolescents diagnosed with ADHD who utilized AKL-T01 for four weeks showed statistically significant improvement on a psychiatric test used to measure their attention and screen for the disorder. Some questions remain, however. The company hasn’t released full study details, so the magnitude of the treatment’s benefit is unclear. And AKL-T01 failed to separate from control on a range of secondary measures tracking behavioral changes.

Nevertheless, Akili reiterated its plan Wednesday to seek FDA clearance “in the coming months.” If the FDA signs off on it, AKL-T01 would become the first prescription digital treatment for pediatric ADHD, the company says.

That would mark another milestone for the emerging field of digital medicines, in which apps or other software serve as the therapy. In September, the FDA approved an app from Pear Therapeutics to treat substance abuse disorders. That ruling was the first of its kind.

Akili is working to advance digital treatments for other conditions besides ADHD. This year, it says it expects to report results from a pilot study of another experimental digital treatment for high-functioning children with autism spectrum disorders; a Phase 2 study of a digital treatment for cognitive dysfunction in adults with depression; and a pilot trial for the digital treatment of cognitive dysfunction in multiple sclerosis.

Xconomy tested a demo version of Akili’s flagship product two years ago—click here to check out takeaways. The company’s technology is based on a decade of research by co-founder Adam Gazzaley’s group at the University of California, San Francisco. Akili was incubated by Boston-based PureTech Health. [An earlier version of this paragraph used PureTech’s old name, PureTech Ventures. We apologize for the error.]