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Akili/Shionogi Begin Ph3 ADHD Study in Japan
Akili/Shionogi Begin Ph3 ADHD Study in Japan.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \n \n \n 1 August 2022\n \n \n \n \n PureTech Health plc\n \n \n \n \n \n \n \n \n \n PureTech Founded Entity Akili Announces Phase 3 Study of Digital Treatment in Children with ADHD Begun by Shionogi in Japan\n \n \n \n \n \n \n \n \n \n Pivotal study follows successful Phase 2 trial, which demonstrated improvements in attention function as compared to both treatment as usual and single task video game groups\n \n \n \n \n \n \n \n \n \n Pivotal Data Readout expected in 2H2023\n \n \n \n \n \n \n \n \n \n PureTech Health plc\n \n (Nasdaq: PRTC, LSE: PRTC) (\"PureTech\" or the \"Company\"), a clinical-stage biotherapeutics company noted that its Founded Entity, Akili Interactive Labs, Inc. (\"Akili\"), a leading digital medicine company, today announced the start of a pivotal Phase 3 randomized, controlled study of SDT-001 (a version of AKL-T01 localized for Japanese language and culture), a product candidate designed to improve measures of attention in children diagnosed with attention-deficit/hyperactivity disorder (\"ADHD\"). The study, conducted by Akili's partner, global pharmaceutical company Shionogi & Co., Ltd. (\"Shionogi\"), is designed to evaluate the safety and efficacy of the product candidate in children ages 6-17 with ADHD as a registration-enabling trial. Clinical trial sites have begun enrolling patients, and results of the study are expected in 2H2023.\n \n \n \n \n \n This study represents the first pivotal study of Akili's video game-based cognitive treatment outside of the U.S. SDT-001 was developed specifically for use in the Japanese market, adapting Akili's AKL-T01 for Japanese language and culture. The disease agnostic proprietary technology is designed to treat impaired cognitive function, specifically attention control. Delivered through an action video game experience, this innovative technology presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function while using adaptive algorithms to personalize the treatment experience for each individual patient.\n \n \n \n \n \n The pivotal study of SDT-001 is being conducted across multiple sites in Japan and is expected to enroll approximately 150 children ages 6-17 years diagnosed with ADHD. The study design was in...