PureTech Founded Entity Akili Announces the Results of EndeavorRx Clinical Study in Pediatric ADHD Published in Nature Digital Medicine - Seite 2

Building on the results of the STARS-ADHD pivotal study of EndeavorRx published in The Lancet Digital Health in February 2020, the STARS Adjunct study evaluated the safety and efficacy of EndeavorRx when used alone and alongside stimulants. The study also assessed the effect of increasing the duration of treatment. Standard clinician ratings of impairments and symptoms were measured, as well as ratings by parents of their children in daily life. The STARS Adjunct study data, along with data from four other clinical studies of EndeavorRx in pediatric ADHD, were presented to the U.S. Food and Drug Administration (FDA) and part of the data package which led to FDA clearance of EndeavorRx in June 2020.

“The results of this study highlight the impact EndeavorRx can have on patients’ day-to-day lives and show the potential benefits of incorporating digital therapeutics into multifaceted treatment plans, including those with traditional pharmacological interventions,” said Anil Jina, M.D., Chief Medical Officer of Akili.

A change in the ADHD Impairment Rating Scale (IRS), a parent-reported assessment scale of ADHD- specific impairments observed in their child’s day-to-day life, was the primary outcome measure of the study. All children participating in the study received the EndeavorRx treatment, with one group also taking stimulant medications and the other not taking medications. Both groups of children demonstrated statistically significant improvements in the IRS compared to baseline (children on stimulants: -0.7, p<0.001; children not on stimulants: -0.5, p<0.001). Half of children (50.0%) were clinical responders to treatment following one month of treatment and over two-thirds (68.3%) of children showed a clinical response following two months of treatment (clinical response pre-defined as IRS improvement of one point or more).

“The findings from this latest study offer additional information about the effectiveness of EndeavorRx in children treated with front-line pharmacotherapy for ADHD,” said Scott Kollins, Ph.D., Professor of Psychiatry and Director of the ADHD Program at the Duke University School of Medicine, faculty member at the Duke Clinical Research Institute (DCRI), and lead author of the publication. “As a clinician who works with children with ADHD, I am happy to see these results from an innovative treatment that can improve both symptoms and impairments in children with ADHD.”