Akili Interactive’s video game digital medicine has shown improvements in attention and inhibitory control in children with ADHD. Success versus the main endpoint in the pivotal trial prepares Akili to file for FDA approval of the digital medicine.
AKL-T01, The digital medicine, is a game patients play on tablet devices. The game uses the same storytelling and reward mechanisms as regular videogames. Though, underneath the surface, it features instruments to act on neural systems and algorithms that connect the level of stimulus up or down to meet the needs of the patient.
The company’s trial gave AKL-T01 or alike tablet-based game that utilized different stimuli to 348 children that ranged between the ages of 8 and 12. Just after 4 weeks, the patients who received AKL-T01 displayed better results on the attention performance index, resulting in a p value of 0.006 and success for the trial versus its main endpoint goal.
This indicates that AKL-T01 may enhance the attention of children with ADHD. Akili now plans to file for approval with the FDA under the 510(k) medical device pathway.
Akili can direct to the primary endpoint success and the shortage of severe adverse events to debate for the approval of the device. Though, the dataset becomes less attractive beyond these vital measures.
AKL-T01 failed to beat the control against a grapple of subjective secondary endpoints, despite steering statistically significant improvements over baseline. The issue for Akili is the control game showed comparable sized improvements.
“AKL-T01 may have wide applicability and is easy to use, plus there is already a large installed base of iPads, hence we believe adoption could in theory be relatively rapid,” Welford wrote in a note to investors. “Akili is pursuing a doctor-prescribed, insurance-reimbursed strategy.”