Following the news of the Japanese expansion, Akilis’ stock was up by 192.8% at market open on 26 February, compared to market close on 23 February. Image Credit: Digital Media Pro / Shutterstock.

Akili has submitted its digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labour, and Welfare as a treatment for attention deficit hyperactivity disorder (ADHD).

The digital therapeutic is a localised version of AKL-T01, which is marketed as EndeavorRx in the US. EndeavorRx was approved as the first prescription digital therapeutic by the US Food and Drug Administration (FDA) for improving attentional functioning in paediatric patients (aged 8-17 years) with ADHD in 2020.

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Following the news of the Japanese expansion, the company’s stock was up by 192.8% at market open on 26 February, compared to market close on 23 February. Akili’s market cap stands at $35.42m.

Shionogi holds the commercialisation rights to the ADHD digital therapeutic in Japan and Taiwan as part of a 2019 collaboration agreement. Under the terms of the partnership, Akili will be entitled to royalties on sales of SDT-001 in the region.

Concurrent with the marketing approval submission, Akili also released the Phase III trial data that was submitted as part of the application. Shionogi conducted the Phase III trial that evaluated the efficacy and safety of SDT-001 in 164 paediatric ADHD patients ages 6-17 years. Following once-daily treatment with SDT-001 for six weeks, the study met its primary endpoint by demonstrating an improvement in the Attention Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Inattention score compared to the control group.

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The participants in the SDT-001 treatment group also showed an improvement in the hyperactivity/impulsivity score at six weeks, compared to the control. The improvement in symptoms was sustained with six additional weeks of therapy. No serious side effects were reported during the trial.

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According to the EndeavorRx website, the digital therapeutic uses sensory stimuli and motor challenges to target areas of the brain that play a key role in attention function. Kids are challenged to multitask and ignore distractions by navigating courses, collecting targets, and avoiding obstacles. It is recommended to play for no more than 25 minutes, five days a week for at least four consecutive weeks, or as prescribed.

GlobalData has identified digital therapeutics as a growing sector in healthcare. The US digital therapeutics is projected to grow at a compound annual growth rate (CAGR) of 25% from 2022 to 2030. However, reimbursement of these therapies is expected to slow the adoption of these therapies, as per a GlobalData report.

GlobalData is the parent company of Clinical Trials Arena.