Shionogi takes Akili’s ADHD digital therapy to Japan

Digital health company Akili is on the brink of its first major expansion beyond the US, partnering with Shionogi to file a localised version of its attention deficit hyperactivity disorder (ADHD) therapy for approval in Japan.

The game-based digital therapeutic (DTx) has been filed for approval with Japan’s Ministry of Health, Labour, and Welfare (MHLW) as a prescription treatment for ADHD based on a clinical trial, carried out in Japanese children aged six to 17, which showed statistically significant improvements in attention and hyperactivity/impulsivity.

Akili notes that Japan could be an important market for the EndeavorRx spinoff, called SDT-001, as access is restricted to many of the drugs used to treat ADHD in the US. That includes most medicines based on stimulants, such as amphetamine salts, although non-stimulant drugs like methylphenidate are available.

“If approved in Japan, it will provide an effective and safe option in a country where some front-line pharmaceutical therapies are not as widely available to paediatric patients with ADHD,” said Dr Scott Kollins, Akili’s chief medical officer.

The prevalence of ADHD has been estimated to be lower in Japan than in North America, at around 0.4% versus 5.3% according to one study, although that could be down to variations in diagnosis and there is some evidence that case numbers have been rising.

The Japanese trial was carried out by Shionogi and was a phase 3 study, enrolling 164 children with ADHD who were being treated with conventional treatments, including environmental adjustments and psychosocial therapies.

Those randomised to 25-minute daily use of SDT-001 for six weeks saw statistically significant improvements in the change from baseline in the ADHD Rating Scale IV (ADHD-RS-IV) Inattention score compared to a control group at the end of that period, the study’s primary endpoint, said Akili.

That was accompanied by significant improvements in the change from baseline in the total ADHD-RS-IV score and the hyperactivity/impulsivity score at the same time point, and the benefit was sustained after a second six-week treatment cycle, according to the company.

Shionogi is an established player in the Japanese ADHD market with Vyvanse (lisdexamfetamine dimesylate), one of the only stimulant drugs approved for use by the MHLW- although, since 2020, it has been subject to a 30-day prescription limit.

It partnered with Akili in 2019 to bring DTx for ADHD and autism spectrum disorder (ASD) to the Japanese market in a deal that included an upfront payment of $10 million and up to $105 million in development and commercial milestones.

The move into Japan comes as Akili has modified its business strategy in the US, with the launch of an over-the-counter version of EndeavorRx, aimed at treating ADHD in adults, in a move that recognised the challenges in building a sustainable prescription DTx business.

EndeavorOTC has been submitted for FDA approval and will be sold directly to adults with ADHD alongside sales of EndeavorRx for children aged eight to 17 with ADHD. The change in strategy sparked an increase in sales in the second and third quarters of 2023, according to the company, which will report its fourth-quarter results later this week.