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PureTech Health's Akili Interactive affiliate announced Wednesday that a study evaluating AKL-T01 in children with attention-deficit hyperactivity disorder (ADHD) showed that the digital therapeutic, which is delivered using an action video game, led to significant improvement on the ADHD Impairment Rating Scale (IRS), regardless of whether children were taking stimulant drugs.
CEO Eddie Martucci remarked that "following our successful pivotal STARS-ADHD study of AKL-T01 as a potential treatment for inattention in children with ADHD not taking stimulant medications, understanding the benefit of our technology when used alongside ADHD medications has been a research priority for us." He added that "we continue to work toward FDA clearance for this novel therapeutic for inattention in children with ADHD."
The STARS-ADHD Adjunctive study included 206 children with ADHD aged eight to 14 years old, with one group taking stimulant drugs while the other did not. All participants received a first period of AKL-T01 treatment in the first month of the trial, followed by a pause in AKL-T01 treatment in the second month, and then a second period of AKL-T01 treatment in the third month. The primary efficacy outcome was change in IRS, a parent-reported clinician-administered ADHD impairment scale, after one month of treatment.
Top-line results showed that the primary endpoint was met, with both cohorts achieving significant improvements in the IRS from baseline after one month, as well as at the three-month mark when the trial ended. "The second period of AKL-T01 treatment resulted in further increases in efficacy on this primary outcome measure, beyond the effects already seen after the first period," Akili said, adding "the magnitude of improvement...throughout the study was similar for children independent of their ADHD medication use."
In addition, responder rates at the end of the first treatment period, defined as an improvement of at least one point on the IRS scale, were 41% in the off-stimulant group and 55% in the on-stimulant group. This increased to 69% and 68%, respectively, by the end of the second period.
Akili has partnered with Shionogi on the digital therapeutic in Japan and Taiwan.
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