Akili Launches EndeavorRx® Expedition - A Direct-to-Patient Product Registry
The fully remote registry is collecting real-world data from participants prescribed EndeavorRx®
This fully remote, direct-to-patient registry is open to any patient who has been prescribed EndeavorRx by their healthcare professional and will provide insights into patient characteristics, usage patterns, and effectiveness of EndeavorRx in a real-world setting. Data from the registry will also be used to help improve the experience and education around the product for patients and caregivers, and enable
“The data we will gain from the registry is critical to expanding the real-world evidence base for physicians, payors, and caregivers alike,” said
Caregivers and patients opt in to the study by providing electronic informed consent (eConsent) and assent (eAssent), as appropriate. Once eConsent and eAssent are obtained, participants and caregivers will provide data via an electronic patient reported outcome (ePRO) platform at baseline, and regular intervals after study enrollment. Potential future enhancements include capturing clinician and educator assessments.
EndeavorRx has been studied in five clinical trials including over 600 children with ADHD, which collectively demonstrated the technology’s ability to improve objective measures and caregiver observations of attention function. The data collected from the registry will further support Akili’s mission to treat the growing and largely unmet medical need of cognitive impairments with its digital therapeutic solutions, first within patients aged 8-12 with ADHD using its flagship product.
EndeavorRx Indication and Overview
EndeavorRx is a digital therapeutic 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. No serious adverse events were reported. Associated adverse events in clinical trials included frustration (
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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 and include, but are not limited to, statements regarding EndeavorRx and the EndeavorRx Expedition Product Registry.
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 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 our ability to achieve and maintain profitability in the future, our ability to achieve and maintain market acceptance and adoption of EndeavorRx and other prescription digital therapeutics by patients and physicians, our ability to obtain and maintain regulatory approval for EndeavorRx and our other product candidates, in the
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mbranch@akiliinteractive.com
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