Akili Interactive’s video game-like digital medicine has improved attention and inhibitory control in children with ADHD. Success against the primary endpoint in the pivotal trial sets Akili up to file for FDA approval of the digital medicine.
The digital medicine, AKL-T01, is a game patients play on tablet devices. The game uses the same storytelling and reward mechanisms as standard videogames. But beneath the surface, it features mechanisms to act on neural systems and algorithms that dial the level of stimulus up or down to meet the needs of the patient.
Akili’s trial gave AKL-T01 or a similar tablet-based game that used different stimuli to 348 children aged eight to 12 years old. After four weeks, the patients who received AKL-T01 performed better on the attention performance index, resulting in a p value of 0.006 and success for the trial against its primary endpoint.
That suggests AKL-T01 may improve the attention of children with ADHD. Akili now plans to file for approval with the FDA under the 510(k) medical device pathway.
The biotech can point to the primary endpoint success and the lack of serious adverse events to argue for the approval of the device. But the dataset becomes less compelling beyond these vital measures.
AKL-T01 failed to beat the control against a clutch of subjective secondary endpoints, despite driving statistically significant improvements over baseline. The problem for Akili is the control game drove similarly sized improvements.
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If Akili can get AKL-T01 past the FDA, attention will then turn to the willingness of payers to cover a novel approach to treating ADHD and the number of patients who want the therapy, either because amphetamines and methylphenidate are ineffective or their parents are unwilling to use pharmacological interventions.
Jefferies analyst Peter Welford thinks sales of AKL-T01 could rise quickly.
“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.”
Shares in PureTech Health, which owns more than 50% of Akili, rose 8% following the news.