Japanese Product Now Under Review for Nationwide Marketing Approval
Akili, Inc. (NASDAQ:AKLI), a leading digital medicine company, today 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, localized version of Akili's AKL-T01 (marketed as EndeavorRx in the United States), which has previously been authorized by the U.S. Food and Drug Administration (FDA) as the world's first prescription digital therapeutic for improving attentional functioning in pediatric ADHD patients aged 8 to 17.
"The latest Japanese clinical trial of our patented, clinically proven technology is an important milestone for many reasons," said Dr. Scott Kollins, Chief Medical Officer at Akili. "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 pediatric patients with ADHD."
The submission for marketing approval in Japan is based on the favorable results of the Phase 3 clinical trial conducted by SHIONOGI in the country. The trial aimed to evaluate the efficacy and safety of SDT-001 in 164 pediatric ADHD patients aged 6 to 17 who received conventional treatments such as environmental adjustments and psychosocial therapies. The SDT-001 group, undergoing approximately 25 minutes of treatment once daily for 6 weeks (1 cycle), demonstrated statistically significant improvements in the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV) Inattention score compared to the control group (continuing conventional treatments) at the 6-week mark (p < 0.05), achieving the primary endpoint of the trial. Moreover, statistically significant improvements were observed in the change from baseline in the total ADHD-RS-IV score and the hyperactivity/impulsivity score at the 6-week mark in the SDT-001 group compared to the control group (p < 0.05). No safety concerns or serious adverse events related to SDT-001 were observed. Furthermore, symptom improvements were sustained even after two cycles of SDT-001 use, with no safety concerns noted.