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Akili Trial Results of EndeavorRx in Adults w/ADHD
Akili Trial Results of EndeavorRx in Adults w/ADHD.
About this update from Puretech Health Plc
[{"type":"text","content":"\n\n4 May 2023\nPureTech Health plc\n \nPureTech Founded Entity Akili Announces Adults with ADHD See Significant Improvements in Attention, ADHD Symptoms, and Quality of Life in Clinical Trial of Akili's EndeavorRx® Video Game-Based Therapeutic\n \nAttention improved in more than 80 percent of adults with ADHD, and over one-third of participants no longer exhibited an attention deficit following treatment\n \nImprovements in attention were nearly seven times larger than those seen in the pivotal trial that supported EndeavorRx's FDA authorization for 8-12 year olds with ADHD\n \nNearly half of adults treated with EndeavorRx met a prespecified threshold for clinically meaningful improvement in their quality of life\n \nPureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (\"PureTech\" or the \"Company\"), a clinical-stage biotherapeutics company noted today that its Founded Entity, Akili, Inc. (Nasdaq: AKLI) (\"Akili\"), a leading digital medicine company, announced topline results of the STARS-ADHD-Adult clinical trial evaluating the efficacy and safety of EndeavorRxⓇ (AKL-T01) in adults with attention-deficit/hyperactivity disorder (ADHD). STARS-ADHD-Adult was designed as a pivotal clinical trial to enable registration with the U.S. Food and Drug Administration (FDA). The trial demonstrated statistically significant improvement in attention functioning after six weeks of treatment, achieving its predefined primary efficacy outcome. Significant improvements were also seen across a range of secondary and exploratory outcomes, including clinical assessments of ADHD-related symptoms and a validated measure of quality of life. EndeavorRx treatment was well-tolerated, with minimal side effects and no serious device-related adverse events reported.\n \nThe multi-center open-label study (NCT05183919) enrolled 221 adults, 18 years of age and older, with inattentive or combined-type ADHD. Patients used the video game-based digital treatment on a mobile device in their homes for six weeks. In the study, EndeavorRx demonstrated a statistically significant improvement in the Test of Variables of Attention (TOVA®)-Attention Comparison Score (ACS) of sustained and selective attention from baseline after six weeks of treatment (p<0.0001), the study's predefined primary efficacy outcome. The change from baseline o...