Akili Inc (NASDAQ:AKLI) announced the topline results of the STARS-ADHD-Adult trial evaluating EndeavorRx (AKL-T01) in adults with attention deficit/hyperactivity disorder (ADHD).
The trial demonstrated statistically significant improvement in attention functioning after six weeks of treatment, achieving its predefined primary efficacy outcome.
Significant improvements were also seen across a range of secondary and exploratory outcomes.
EndeavorRx treatment was well-tolerated, with minimal side effects and no serious device-related adverse events reported.
EndeavorRx is the first-and-only FDA-authorized treatment delivered through a video game experience for inattention in children ages 8-12 with ADHD.
In January, Akili announced topline data from a pivotal study of EndeavorRx in adolescents with ADHD ages 13-17.
Nearly 72.5% of adults reported at least some improvement in their quality of life, and nearly 45.8% met a prespecified threshold for clinically meaningful improvement.
Overall, 11 of the participants in the trial (5%) reported a treatment-emergent adverse device event, most commonly nausea (1.8%) and headache (1.4%). There were no serious adverse device events.
Additional study information and results:
83% of patients demonstrated a clinical response to the treatment.
Over one-third (36.6%) of adults with ADHD moved into the non-clinical or normative range.
Price Action: AKLI shares are up 33.90% at $1.46 on the last check Wednesday.
