PureTech Health plc (LON:PRTC), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, has said that its Founded Entity, Akili, has been granted US Food and Drug Administration (FDA) clearance for EndeavorRxTM (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). Delivered through a captivating video game experience, EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. See full indication below. Persistent attention issues have a significant impact on the daily lives of millions of people. Attention impairments are a key component of ADHD for many children.
Daphne Zohar, founder and chief executive officer of PureTech Health said: “The FDA clearance of EndeavorRx is a tremendous milestone as it represents an entirely new class of medicine for children and their families. 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 R&D 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. Further, about half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx; this 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 FDA’s de novo pathway and its clearance creates a new class of digital therapeutics. EndeavorRx is designed to directly target and activate neural systems through the presentation of sensory stimuli and motor challenges to improve cognitive functioning. The EndeavorRx treatment will be available with a prescription to families soon.
EndeavorRx is the second product developed from PureTech Health’s unique R&D model to achieve FDA clearance. In April 2019, Gelesis announced the FDA clearance of PlenityTM as an aid in weight management in overweight and obese adults with a BMI of 25-40 kg/m2, when used in conjunction with diet and exercise. Gelesis also recently received approval to market Plenity in Europe. For the safe and proper use of Plenity, refer to the US Instructions for Use or the EU Instructions for Use.
