Akili and Shionogi Declare Success in Phase 3 Clinical Trial for EndeavorRx as ADHD Treatment for Japanese Children
Overview
- Company: Akili, Inc. & Shionogi & Co. Ltd
- Indication: Pediatric ADHD
- Drug: SDT-001 (localized version of AKL-T01 / EndeavorRx)
- Trial Phase: Phase 3
- NCT ID: N/A
Akili, Inc., in collaboration with Shionogi & Co. Ltd, announced the successful completion of a Phase 3 clinical trial in Japan for SDT-001, the localized version of the prescription digital therapeutic AKL-T01, known as EndeavorRx in the U.S. The trial included 164 pediatric ADHD patients, aged 6 to 17 years, and evaluated the efficacy and safety of SDT-001 over a 6-week treatment period.
Primary endpoints were met with statistically significant improvements in ADHD-RS-IV scores, particularly for inattention, overall ADHD symptoms, and hyperactivity/impulsivity after 6 weeks. No safety concerns or serious adverse events were associated with the use of SDT-001.
Approval by Japanese regulatory authorities could lead to SDT-001 becoming a novel, accessible option for ADHD treatment in Japan's medical system.
Efficacy and Safety Results
- Participants: 164 children with ADHD
- Treatment Duration: Approximately 25 minutes daily, 6 weeks
- Primary Endpoint: Significant enhancement in ADHD-RS-IV scores
- Safety: No serious adverse events or safety concerns
Market Authorization and Implications
Akili aims to submit SDT-001 for marketing authorization in Japan. The digital therapeutic has the potential to offer an effective and safe treatment option for pediatric ADHD, particularly in a landscape with limited pharmaceutical options.
Akili's advancement demonstrates PureTech Health's commitment to transforming the healthcare experience through innovative digital therapeutics.