Akili: EndeavorRx trial to treat ADHD in adolescents shows robust improvements

Akili announced topline results of the STARS-ADHD-Adolescents label expansion study evaluating the efficacy and safety of EndeavorRx in adolescents ages 13-17 with attention-deficit/hyperactivity disorder ADHD . The pivotal study achieved its predefined primary efficacy outcome, showing statistically significant improvement in attentional functioning after four weeks of treatment. Consistent improvements were also seen in a range of secondary measures of ADHD-related inattention symptoms and functioning. EndeavorRx treatment was generally well-tolerated, with no serious device-related adverse events reported…"The results of this study extend the already substantial evidence base to support the efficacy of EndeavorRx for improving attentional functioning in patients with ADHD, and most importantly show the ability of this safe treatment to help teenagers, who have been significantly impacted by the current mental health crisis," said Scott Kollins, Ph.D., chief medical officer of Akili…Akili plans to present full data from the STARS-ADHD-Adolescents study at a future medical meeting, and the company will file for EndeavorRx label expansion with FDA in 2023. As part of Akili’s label expansion strategy for EndeavorRx, in addition to the study in adolescents, the company has been conducting a separate pivotal trial of EndeavorRx in adults with ADHD. As was previously noted during the company’s last earnings call, recruiting for that adult study has been slower than projected. Based on this strong clinical data in adolescents and the desire to maximize capital efficiency, Akili has stopped recruitment of the adult study with 224 patients enrolled in order to analyze the trial data ahead of schedule.