Akili Interactive said a clinical trial of its lead investigational digital medicine, AKL-T01, met its main goal in children and adolescents diagnosed with attention deficit hyperactivity disorder.
In the STARS-ADHD randomized controlled trial, 348 children and adolescents with ADHD and objective attention deficits were evaluated before and after four weeks of at-home treatment with either AKL-T01 or an active control, which was designed and tested to have a similar level of expectation of benefits and engagement.
The PureTech Health PLC affiliate said children and adolescents receiving AKL-T01 showed a statistically significant improvement in attentional functioning when compared to no improvement in the active control group.
Akili said AKL-T01 was safe and well-tolerated with only 11 treatment-related side effects reported, primarily headache and frustration.
Based on the results of the study, Akili plans to file AKL-T01 with the U.S. Food and Drug Administration for clearance as a treatment for children and adolescents with ADHD.