Akili, Inc. announced topline results of the STARS-ADHD-Adolescents label expansion study evaluating the efficacy and safety of EndeavorRx? (AKL-T01) 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 multi-center open-label study enrolled 162 adolescents ages 13-17 with inattentive or combined-type ADHD.

In the study, EndeavorRx demonstrated a statistically significant improvement in the Test of Variables of Attention (TOVA®)-Attention Comparison Score (ACS) of sustained and selective attention from baseline after one month of treatment (p<0.0001), the study's predefined primary efficacy outcome. The change from baseline on the TOVA ACS was nearly three times as large as the changes seen in STARS-ADHD, a large randomized controlled trialof children with ADHD ages 8-12 that served as the basis for EndeavorRx's U.S. Food and Drug Administration (FDA) authorization in that age group. In the STARS-ADHD-Adolescents study, nearly two-thirds (66%) of adolescents met the prespecified definition of clinical response on the TOVA-ACS and nearly a quarter (24.7%) moved into the non-clinical, or normative, range.

TOVA is a computerized test cleared by FDA to assess attention deficits and evaluate the effects of interventions in ADHD. Adolescents using EndeavorRx also saw significant improvement in ADHD symptoms, as measured by the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores. ADHD-RS is a clinician-administered questionnaire based on information collected from the child's caregiver.

Following treatment, participants in the study showed significant improvement on both the inattention subscale and total score of the ADHD-RS (p<0.0001 for both). A prespecified responder analysis also showed that 27.1% of all participants in the study demonstrated at least a 30% reduction in total scores on the ADHD-RS, a finding similar to the STARS-ADHD trial in children with ADHD (24%). Statistically significant improvements were also observed for parent and child ratings of attention improvement, as well as parent ratings of function across a number of domains, including peer relationships, academic functioning, behavioral functioning, homework functioning, and self-esteem.

Overall, 4 (2.5%) participants experienced a treatment-emergent adverse device event (3 decreased frustration tolerance, 1 headache; all mild or moderate). There were no serious adverse device events.