PureTech Founded Entity Akili Announces the Results of EndeavorRx Clinical Study in Pediatric ADHD Published in Nature Digital Medicine - Seite 3

Also measured were clinician-reported assessments of the ADHD Rating Scale (ADHD-RS) and the mean clinical global impression of improvement (CGI-I). Statistically significant improvements were seen across both assessments in children, regardless of whether they were using EndeavorRx alone or alongside stimulants. ADHD-RS symptom response rates were similar for children both on and off ADHD medication, with 27.2% of children responding to treatment following one month of treatment and 45.3% following two months of treatment (clinical response on ADHD-RS predefined as ≥30% reduction in symptoms).

The STARS Adjunct study also looked at the duration of effects of EndeavorRx. Four weeks following treatment, ADHD-RS scores remained significantly improved for participants in both children who used EndeavorRx alone and those who used the treatment alongside stimulants (all p<0.001).

The safety profile of EndeavorRx was consistent with that seen in all previous clinical studies of the product; the treatment was well-tolerated with no serious adverse events.

EndeavorRx has been studied in more than 600 children with ADHD across five clinical trials, including a large, multicenter prospective randomized controlled study. Based on the totality of data from those studies which showed clinical benefit in attention as measured by computer-based testing, academic performance measures, and other assessment tools, EndeavorRx was cleared by the U.S. Food and Drug Administration (FDA), making it the first prescription treatment delivered through a video game.

EndeavorRx^TM Indication and Overview

EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication.