Akili, Inc., a leading digital medicine company, has announced that its Japanese partner Shionogi & Co. Ltd has submitted Akili’s digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare. SDT-001 is the Japanese version of Akili’s AKL-T01 (marketed as EndeavorRx® in the United States), previously authorised by the U.S. Food and Drug Administration (FDA) as the world's first prescription digital therapeutic for improving attentional functioning in paediatric ADHD patients aged 8 to 17.
Dr. Scott Kollins, Chief Medical Officer at Akili, stated, “The latest Japanese clinical trial of our patented, clinically proven technology is an important milestone for many reasons. It not only further validates the efficacy and safety of EndeavorRx, it also moves us and our international partner SHIONOGI a step closer to making the product available in Japan. And if approved in Japan, it will provide an effective and safe option in a country where some front line pharmaceutical therapies are not as widely available to paediatric patients with ADHD.”
The submission for marketing approval in Japan is based on the positive results of the Phase 3 clinical trial conducted by SHIONOGI in the country. The trial evaluated the efficacy and safety of SDT-001 in 164 paediatric ADHD patients aged 6 to 17 who received conventional treatments. The SDT-001 group demonstrated statistically significant improvements in the Attention-Deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV) Inattention score compared to the control group at the 6-week mark, achieving the primary endpoint of the trial. Furthermore, significant improvements were observed in the total ADHD-RS-IV score and the hyperactivity/impulsivity score. No safety concerns or serious adverse events related to SDT-001 were observed, and symptom improvements were sustained even after two cycles of SDT-001 use.
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