Positive Results from Phase 3 Clinical Trial of Digital Therapeutic App SDT-001 and Submission for Marketing Approval in Japan
February 27, 2024 – Clinical Trials – ADHD, Akili, Shionogi, marketing approval
26 February 2024 — Osaka, Japan — Shionogi & Co announces the submission of a marketing approval application for the digital therapeutic app SDT-001, for commercialisation and sale in Japan, as of 26 February 2024.
SDT-001 is a digital therapeutic app designed for the treatment of paediatric patients with attention deficit hyperactivity disorder (ADHD). Developed by Akili, SDT-001 is the Japanese, localised version of Akili’s AKL-T01 (marketed as EndeavorRx in the US), which has already obtained authorisation from the US Food and Drug Administration (FDA) as the world’s first prescription digital therapeutic app for improving attentional functioning in paediatric ADHD patients aged 8-17. Additionally, Akili has acquired the CE mark for distribution in Europe.
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 paediatric ADHD patients aged 6-17 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.
About Shionogi
Shionogi is committed to realising the SHIONOGI Group Vision of “Building Innovation Platforms to Shape the Future of Healthcare” by transforming into a “Healthcare as a Service (HaaS)” company. While enhancing our strengths as a research-based pharmaceutical company, we aim to provide diverse treatment options beyond medicinal products, including collaborations with external partners, to contribute to improving the quality of life for patients and their families. Visit: www.shionogi.com.
About Akili
Akili is pioneering the development of cognitive treatments through game-changing technologies. Akili’s approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device, but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programmes. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.
