(Alliance News) - PureTech Health PLC on Friday said the topline results for the pivotal trial of its EndeavorRx treatment showed "robust improvements in attention and broader clinical outcomes".
The London-based biotherapeutics company said its founded entity Akili Inc - a digital medicine company - announced the results of the STARS-ADHD-Adolescents label expansion study, which showed "statistically significant improvement in attentional functioning after four weeks of treatment".
The study of EndeavorRx - the first US FDA-authorised treatment delivered through a video game experience - evaluates the efficacy and safety of the treatment in adolescents between the ages of 13 and 17 with attention deficit hyperactivity disorder.
The company said there were improvements in a range of secondary ADHD-related inattention symptoms and functioning, while the treatment was generally well-tolerated. The company said the most common side effect observed in children was frustration, "as the game can be quite
challenging at times".
Akili is also conducting an adult trial of the ADHD treatment, the company said it has stopped recruiting patients with 224 patients enrolled, following the "strong clinical data" from the adolescent trial, in order to analyse the adult trial data ahead of schedule.
Puretech said Akili will use the data from its adolescents study to file for label expansion of EndeavorRx with FDA in 2023.
Puretech shares were down 0.7%, trading at 268.50 pence per share on Friday morning in London.
By Harvey Dorset, Alliance News reporter
Comments and questions to newsroom@alliancenews.com
Copyright 2023 Alliance News Ltd. All Rights Reserved.


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