Pivotal Trial of EndeavorRxⓇ in Adolescents with ADHD Shows Robust Improvements in Attention and Broader Clinical Outcomes
- Attention improvements were nearly three times as large as those in the pivotal trial that served as the basis for EndeavorRx’s FDA authorization for children with ADHD ages 8-12
- Study data will be used to file for EndeavorRx label expansion with FDA in 2023
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Akili has stopped recruitment in separate adult ADHD trial to allow for earlier data analysis
EndeavorRx FDA authorized video game for kids with ADHD (Photo: Business Wire)
“The results of this study extend the already substantial evidence base to support the efficacy of EndeavorRx for improving attentional functioning in patients with ADHD, and most importantly show the ability of this safe treatment to help teenagers, who have been significantly impacted by the current mental health crisis,” said
The multi-center open-label study enrolled 162 adolescents ages 13-17 with inattentive or combined-type ADHD. 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 one month of treatment (p<0.0001), the study’s predefined primary efficacy outcome. The change from baseline on the TOVA ACS was nearly three times as large as the changes seen in STARS-ADHD, a large randomized controlled trial of children with ADHD ages 8-12 that served as the basis for EndeavorRx’s
Adolescents using EndeavorRx also saw significant improvement in ADHD symptoms, as measured by the Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS) inattention subscale and total scale scores. ADHD-RS is a clinician-administered questionnaire based on information collected from the child's caregiver. Following treatment, participants in the study showed significant improvement on both the inattention subscale and total score of the ADHD-RS (p<0.0001 for both). A prespecified responder analysis also showed that
EndeavorRx Indication and Overview
EndeavorRx is the first-and-only FDA-authorized treatment delivered through a video game experience. EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8 to 12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Test of Variables of Attention (TOVA®) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. EndeavorRx is available by prescription only. It is not intended to be used as a stand-alone therapeutic and is not a substitution for a child’s medication. The most common side effect observed in children in EndeavorRx’s clinical trials was a feeling of frustration, as the game can be quite challenging at times. No serious adverse events were associated with its use. EndeavorRx is recommended to be used for approximately 25 minutes a day, 5 days a week, over initially at least 4 consecutive weeks, or as recommended by your child’s health care provider. To learn more about EndeavorRx, please visit EndeavorRx.com.
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Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties.
These forward-looking statements include, without limitation, statements in this press release related to: our expectations with respect to timing of a regulatory submission to FDA for EndeavorRx (AKL-T01) and our aim to expand the EndeavorRx label; our clinical development plans, including the timing of enrollment for and analysis of data from clinical trials as well as the release of additional clinical data; and the likelihood that data from clinical trials will be positive and support further clinical development and regulatory approval of AKL-T01. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: the risk that prior results, such as signals of efficacy or safety observed from clinical trials of AKL-T01 will not continue or be repeated in our ongoing or planned clinical trials of AKL-T01, will be insufficient to support regulatory submissions or support or maintain marketing approval in
View source version on businesswire.com: https://www.businesswire.com/news/home/20230105005322/en/
SVP, Communications
julie@akiliinteractive.com
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