Dive Brief:
- Akili Interactive shared early results of a single-arm study that found adults with attention deficit hyperactivity disorder (ADHD) had improved attention after using its video game-based treatment for six weeks.
- The company’s digital therapeutic, EndeavorRx, currently is cleared to treat children ages 8 to 12 with ADHD. It hopes to expand the treatment to adults and adolescents with the Food and Drug Administration’s blessing.
- Shares of Akili surged 37% to $1.49 in Wednesday morning trading after the company reported the results.
Dive Insight:
Akili plans to submit data from the pivotal trial to the FDA later this year. The early study results showed that attention improved in more than 80% of adults with ADHD, and more than one-third of participants no longer exhibited an attention deficit following treatment.
The study enrolled 221 adults with inattentive or combined-type ADHD, who used the company’s video-game based treatment on a mobile device at home for six weeks. About 70% of the participants were women. Results were measured using the Test of Variables of Attention (TOVA) Attention Comparison Score.
Akili Chief Medical Officer Scott Kollins said the study of EndeavorRx in adults exceeded the results the company saw in kids and adolescents, and that adults saw meaningful improvements in their quality of life. There were some differences between the studies: The trial done in children was a randomized, controlled trial, while the study in adults had no control group and ran for about two weeks longer.
“These data come at a critical time when there is growing demand among adults with ADHD for safe, effective, and accessible non-drug treatments. It is increasingly recognized that current available options are not working, and/or are not available,” Kollins said in a statement. “We are deeply committed to getting this treatment to patients as quickly as possible.”
Akili hopes to grow its business by expanding its video game-based treatment for ADHD to adults and adolescents.
If regulators clear both label expansions, Akili estimates a $500 million per year revenue opportunity by 2027 to 2029, the company said in its most recent annual report. This assumes an 8% market share and an average price of $300 to $350 per prescription.
Still, the company faces hurdles in reaching that goal amid a challenging market where other digital therapeutics firms have struggled. Pear Therapeutics, a leader in the space, filed for bankruptcy last month.
Akili last year recorded revenue of $323,000, a 40% decrease from 2021, due to the end of a collaboration agreement with pharmaceutical company Shionogi. Akili also reported a net loss of $7.96 million.
The company earlier this year trimmed 30% of its staff to extend its cash runway and focus on selling EndeavorRx.
