• 28 Feb 2024
• Admin
• News Article

Shionogi Requests Approval for SDT-001 App

Shionogi seeks Japanese marketing approval for digital therapeutic app SDT-001

Overview

Shionogi & Co., Ltd. announces the submission of a marketing approval application for the digital therapeutic app SDT-001, for commercialization and sale in Japan, as of February 26, 2024.

About SDT-001

• SDT-001 is a digital therapeutic app designed for the treatment of paediatric patients with attention deficit hyperactivity disorder (ADHD). 
• Developed by Akili, Inc.  SDT-001 is the Japanese, localized version of Akili’s AKL-T01 (marketed as EndeavorRx in the United States), which has already obtained authorization 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 to 17. 
• Additionally, Akili has acquired the CE mark for distribution in Europe.

Results from Phase III Study

• The submission for marketing approval in Japan is based on the favourable 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 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.

Vision of Shionogi

Shionogi is committed to realizing 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.

About App

• SDT-001 is a digital therapeutic application developed by Akili, exclusively licensed by Shionogi for clinical development, commercialization and distribution in Japan and Taiwan. 
• By engaging with this application on smartphones or tablets, it is designed to improve attentional functioning in patients with ADHD1. 
• Designed to activate the prefrontal cortex, a crucial area for cognitive functions, and based on Akili's Selective Stimulus Management Engine (SSMETM) core technology, SDT-001 provides optimized dual tasks tailored to individual patients to stimulate cortical activity, shown to be associated with improvements in the patient's attentional control.

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.