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(Sharecast News) - Clinical-stage biotherapeutics investor PureTech Health announced on Friday today that its digital medicine company Akili, which it founded, announced topline results of the 'STARS-ADHD-Adolescents' label expansion study evaluating the efficacy and safety of 'EndeavorRx', or 'AKL-T01' in adolescents aged 13 to 17 with attention-deficit hyperactivity disorder (ADHD).
The London-listed firm said the pivotal study achieved its predefined primary efficacy outcome, showing statistically significant improvement in attentional functioning after four weeks of treatment.
Consistent improvements were also seen in a range of secondary measures of ADHD-related inattention symptoms and functioning.
It said EndeavorRx treatment was generally well-tolerated, with no serious device-related adverse events reported.
"Akili plans to present full data from the STARS-ADHD-Adolescents study at a future medical meeting, and the company will file for EndeavorRx label expansion with FDA in 2023," PureTech said in its statement.
"As part of Akili's label expansion strategy for EndeavorRx, in addition to the study in adolescents, the company has been conducting a separate pivotal trial of EndeavorRx in adults with ADHD."
PureTech said that as was noted during the company's last earnings call, recruiting for that adult study had been slower than projected.
"Based on this strong clinical data in adolescents and the desire to maximise capital efficiency, Akili has stopped recruitment of the adult study with 224 patients enrolled in order to analyse the trial data ahead of schedule."
At the close on Friday, shares in PureTech Health were down 0.18% at 270p.
Reporting by Josh White for Sharecast.com.
