Positive Phase 3 Trial Outcomes for EndeavorRx® in Japanese Pediatric ADHD

A digital therapeutic product developed by Akili Interactive Labs is currently being evaluated for marketing authorization in Japan. The product, known as SDT-001, is a localized Japanese version of Akili’s EndeavorRx, which has already been approved by the U.S. FDA as the first prescription digital therapeutic for enhancing attention in children with ADHD between the ages of 8 and 17.

Dr. Scott Kollins, Akili’s Chief Medical Officer, highlighted the significance of the recent clinical trial conducted in Japan, emphasizing its role in validating the product's efficacy and safety. He also noted that the approval of SDT-001 in Japan would provide a valuable alternative for pediatric ADHD patients in a country where traditional pharmaceutical options are less accessible.

The Phase 3 clinical trial in Japan involved 164 children aged 6 to 17 who were undergoing conventional treatments. The trial demonstrated that the SDT-001 group, which received about 25 minutes of treatment daily for six weeks, showed significant improvements in attention and hyperactivity scores compared to the control group. Importantly, no serious adverse events were associated with the use of SDT-001, and the improvements were sustained even after two cycles of treatment.

Akili Interactive Labs is a frontrunner in the field of digital medicine, developing cognitive treatments through innovative technologies. Their platform is based on proprietary therapeutic engines that target cognitive impairment at its source in the brain. Akili’s products are designed to be engaging and fun, delivered through action video game experiences, reflecting their belief that effective medicine can also be enjoyable.

Shionogi & Co., Ltd., Akili’s Japanese partner, is dedicated to shaping the future of healthcare through innovation. The company aims to provide a range of treatment options beyond medicinal products, including collaborations with partners like Akili, to enhance the quality of life for patients and their families.

Akili’s product suite for ADHD includes EndeavorRx and EndeavorOTC. EndeavorRx is prescribed to improve attention function in children with ADHD and is not intended as a standalone therapeutic. It is recommended for use alongside other therapeutic programs. EndeavorOTC is a digital therapeutic for adults with ADHD, utilizing the same technology as EndeavorRx but is not FDA-cleared or authorized for any indications.