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Akili's New ADHD Trial Met Primary Endpoint
Akili's New ADHD Trial Met Primary Endpoint.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \nRNS Number : 8495Z PureTech Health PLC 15 January 2020 \n\n15 January 2020\nPureTech Health plc\n \nPureTech Affiliate Akili Announces New AKL-T01 Study Achieved Primary Endpoint in Children with ADHD \n \nAKL-T01 showed statistically significant improvement in ADHD Impairment Rating Scale (IRS), when used alone and as adjunct to stimulants\n \nAkili continues to pursue FDA clearance for AKL-T01 as a potential treatment of inattention in paediatric ADHD\n \nPureTech Health plc (LSE: PRTC) (\"PureTech\") is pleased to note that its affiliate, Akili, today announced top-line results of its multi-site open-label study (STARS-ADHD Adjunctive) to evaluate the effects of AKL-T01 in children with Attention Deficit Hyperactivity Disorder (ADHD) when used with and without stimulant medication. The effects of increasing the duration of treatment were also studied. The study achieved its predefined primary efficacy outcome, demonstrating a statistically significant improvement in the ADHD Impairment Rating Scale (IRS) from baseline after one month of treatment (p<0.001) in both children taking stimulant medications and in those not taking stimulants.\n \nEric Elenko, PhD, chief innovation officer at PureTech, said: \"We are pleased with these new results as they provide additional support for AKL-T01 in paediatric ADHD - both as a monotherapy and in combination with stimulant medications. This study also builds on the previously reported cognition findings by demonstrating efficacy on the IRS, which is a scale of ADHD-specific symptoms that provides measures of the real-world consequences of ADHD symptoms.\"\n \nThe STARS-ADHD Adjunctive study is the fifth clinical study evaluating AKL-T01 in children with ADHD. In STARS-ADHD, AKL-T01 demonstrated a statistically significant improvement compared to control (p=0.006) on the predefined primary endpoint, a composite score from the Test of Variables of Attention (TOVA®), an objective measure of attention, after one month of treatment. Across all studies to-date, AKL-T01 has been shown to be safe and well tolerated. Akili filed for clearance of AKL-T01 for the treatment of children with ADHD with the United States Food and Drug Administration (FDA) in 2018. Clearance has not yet been granted, and Akili continues to work with FDA in an effort to ...