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

A significant development in digital therapeutics for pediatric ADHD has been announced by Akili, Inc., a company at the forefront of digital medicine. Their product, SDT-001, a localized version of the U.S. FDA-approved EndeavorRx®, is currently under review for marketing approval in Japan by Shionogi & Co. Ltd, Akili's Japanese partner. EndeavorRx® has been recognized globally as the first prescription digital therapeutic specifically designed to enhance attentional functioning in children and adolescents aged 8 to 17 with ADHD.

Eric Elenko, Chief Innovation Officer at PureTech Health, expressed enthusiasm about the product's potential impact on Japanese pediatric patients with ADHD, should it be approved. The submission for approval is supported by the positive outcomes of a Phase 3 clinical trial conducted by Shionogi in Japan, which demonstrated SDT-001's efficacy and safety in improving attention deficits in 164 pediatric patients who had been receiving conventional treatments.

The trial showed that patients who engaged with SDT-001 for approximately 25 minutes daily over a six-week period exhibited significant improvements in the Attention-Deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV) Inattention score, as well as in the total ADHD-RS-IV score and the hyperactivity/impulsivity score, compared to the control group. Importantly, no serious adverse events related to SDT-001 were reported, and the benefits were sustained even after two cycles of use.

Akili's EndeavorRx® and EndeavorOTC® form part of their suite of cognitive treatment products for ADHD. EndeavorRx® is prescribed to improve attention function in children with primarily inattentive or combined-type ADHD and is intended to be used as part of a broader therapeutic program. EndeavorOTC®, meanwhile, is a digital therapeutic for improving attention function, ADHD symptoms, and quality of life in adults with ADHD.

Akili's approach to cognitive treatments is innovative, targeting cognitive impairment at its source in the brain through engaging action video game experiences. This new category of medicine is validated through clinical trials and experienced like entertainment, reflecting Akili's belief that effective medicine can also be enjoyable.

Shionogi & Co. Ltd, committed to shaping the future of healthcare, aims to provide diverse treatment options, including collaborations like the one with Akili, to enhance the quality of life for patients and their families.

The potential authorization of SDT-001 in Japan would mark a significant milestone for Akili and its partner Shionogi, offering a safe and effective digital therapeutic option to pediatric patients with ADHD in a country where traditional pharmaceutical therapies may not be as accessible. This development underscores the growing importance and potential of digital therapeutics in addressing critical healthcare needs globally.