PureTech Founded Entity Akili Announces Positive Results from Shionogi's Phase 3 Clinical Trial of Localized Version of Akili's EndeavorRx ® for Pediatric ADHD Patients in Japan

Core Viewpoint - PureTech Health's Founded Entity Akili, Inc. has submitted its digital therapeutic SDT-001 for marketing approval in Japan, which is a localized version of its FDA-approved product EndeavorRx for pediatric ADHD patients [1][2][3] Group 1: Company Developments - Akili's SDT-001 is under review by Japan's Ministry of Health, Labor, and Welfare, following positive results from a Phase 3 clinical trial conducted by its partner Shionogi [2][3] - The Phase 3 trial involved 164 pediatric ADHD patients aged 6 to 17, showing statistically significant improvements in ADHD symptoms after 6 weeks of treatment with SDT-001 compared to a control group [3] - The treatment group demonstrated significant improvements in ADHD-RS-IV Inattention scores and total ADHD-RS-IV scores, with no safety concerns reported [3] Group 2: Market Potential - If approved, SDT-001 will provide a new treatment option for pediatric patients with ADHD in Japan, where some traditional pharmaceutical therapies are less accessible [3] - The submission for marketing approval is seen as a critical step towards addressing the needs of ADHD patients in Japan [2][3] Group 3: Company Background - PureTech Health is a clinical-stage biotherapeutics company focused on developing innovative treatments for patients with severe diseases, leveraging a broad pipeline of therapeutic candidates [10][11] - Akili is recognized for pioneering cognitive treatments through engaging technologies, establishing a new category of medicine that combines clinical validation with entertainment [8]