PureTech gets FDA clearance for video game ADHD treatment

Clinical-stage biotherapeutics company PureTech Health announced on Tuesday that its subsidiary Akili has been granted US Food and Drug Administration (FDA) clearance for ‘EndeavorRx’, or AKL-T01, as a prescription treatment for children with attention deficit hyperactivity disorder (ADHD).

The FTSE 250 company said EndeavorRx, delivered through a video game experience, was indicated to improve attention function as measured by computer-based testing in children aged between eight and 12 years with primarily inattentive or combined-type ADHD, who had a demonstrated attention issue.

It said persistent attention issues had a “significant” impact on the daily lives of millions of people, with attention impairments a key component of ADHD for many children.

“The FDA clearance of EndeavorRx is a tremendous milestone as it represents an entirely new class of medicine for children and their families,” said PureTech founder and chief executive officer Daphne Zohar.

“EndeavorRx is the first digital therapeutic intended to improve symptoms associated with ADHD, and it is also the first game-based therapeutic to be granted marketing authorisation by the FDA for any type of condition.

“EndeavorRx is now the second product developed from PureTech's unique research and development model to receive FDA clearance, and is further validation of our approach to inventing, identifying, and advancing truly innovative medicines for patients.”

EndeavorRx was granted clearance based on data from five clinical studies in more than 600 children diagnosed with ADHD, including a prospective, randomised, controlled study published in the Lancet Digital Health journal, which showed EndeavorRx improved objective measures of attention in children with ADHD.

After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention.

Additionally, about half of parents saw a “clinically meaningful” change in their child's day-to-day impairments after one month of treatment with EndeavorRx, which increased to 68% after a second month of treatment.

Improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month.

EndeavorRx was reviewed through the FDA's de novo pathway, PureTech explained, and its clearance created a new class of digital therapeutics.

It was designed to directly target and activate neural systems through the presentation of sensory stimuli and motor challenges to improve cognitive functioning.

PureTech said the EndeavorRx treatment would be available with a prescription to families soon.

The board said it was the second product developed from its unique research and development model to achieve FDA clearance.

In April 2019, Gelesis announced the FDA clearance of ‘Plenity’ as an aid in weight management in overweight and obese adults with a BMI of between 25 and 40, when used in conjunction with diet and exercise.

Gelesis also recently received approval to market Plenity in Europe.

At 0809 BST, shares in PureTech Health were up 6.77% at 256.25p.