A Japanese-language version of Akili Interactive’s breakthrough EndeavorRx digital therapy for attention deficit hyperactivity disorder (ADHD) has begun a Phase 3 trial, with results expected next year.
The study is being led by Japanese drugmaker Shionogi, which formed a strategic partnership with Akili in 2019 to bring digital therapies (DTx) to Asian markets.
The ADHD app – renamed SDT-001 and modified to take into account Japanese language and culture – is one of two covered by the initial agreement, the second being for children with autism spectrum disorders (ASD) .
The trial of the app is being conducted in children aged 6 to 17 with ADHD, with an enrollment goal of 150, and is designed to support regulatory approval in Japan. This is the first pivotal study of Akili’s video game-based cognitive processing outside of the United States.
EndeavorRx (AKL-T01) is already approved in Europe and the United States, becoming the first DTx for ADHD in these two markets.
The app is designed to target and activate neural systems by presenting sensory stimuli and motor challenges to improve cognitive functioning in ADHD, particularly attention control, and is used alongside other treatments such as clinician-directed therapy, medication, and education to treat the disorder.
The results of the phase 3 trial are expected in the second half of 2023. It will take place in two parts, starting with a stage where the application will be superimposed on the usual treatment of children for ADHD, and its effects compared to a matched group receiving usual treatment alone.
In a second step, all children will receive SDT-001 therapy, allowing a before and after comparison in the control group. The app will be used for 25 minutes a day, seven days a week, for six weeks, with its effects measured using the ADHD-RS-IV inattention subscale.
Shionogi has already demonstrated proof of concept in a phase 2 study in 261 children aged 6-17 who were randomized to receive either their usual treatment, a single-task video game as a control app, or SDT-001, Akili said in a statement. .
The SDT-001 treatment group showed greater improvements on clinical parameters compared to the usual treatment and control application groups, but was unable to show a significant benefit over the application control.
“ADHD is having a significant impact on children and their families in Asia, and caregivers and healthcare providers are looking for innovative, non-drug treatment options,” said Takeki Uehara, Head of Drug Development and Regulatory Sciences. at Shionogi.
“Following the success of our Phase 2 study of SDT-001, we are excited to advance Akili’s product candidate through the clinical process to potentially help the millions of children living in Japan with ADHD,” said- he added.
Akili is also working on versions of the software for ASDs as well as other conditions like multiple sclerosis, major depressive disorder, COVID-19 “brain fog,” cancer-related cognitive impairment, and postoperative cognitive dysfunction.
The company caters to a growing market valued at around $25 billion in 2020 and is expected to grow around 15% annually to reach $65 billion in 2027, according to market research firm GMI.
The digital health specialist is part of a group of companies founded by PureTech, which retains a majority stake.
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