The fully remote registry is collecting real-world data from participants prescribed EndeavorRx®
Akili Interactive (“Akili”), a leading digital medicine company, today announced the EndeavorRx® Expedition product registry, which aims to obtain feedback from patients receiving the digital therapeutic, and their caregivers, to determine the real-world effectiveness of EndeavorRx. EndeavorRx is the first and only prescription video game treatment cleared by the U.S. Food and Drug Administration (FDA) and is indicated to improve attention function in 8-12 year old children diagnosed with attention-deficit/hyperactivity disorder (see full indication below).
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 Akili to iterate its product based on feedback and data received via the registry.
“The data we will gain from the registry is critical to expanding the real-world evidence base for physicians, payors, and caregivers alike,” said Anil Jina, M.D., Chief Medical Officer of Akili.
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 (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). All adverse events were generally transient. 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.
Akili is pioneering the development of cognitive treatments through game-changing technologies. Our approach of leveraging technologies designed to directly target the brain establishes a new category of medicine – medicine that is validated through clinical trials like a drug or medical device, but experienced like entertainment. Akili’s platform is powered by proprietary therapeutic engines designed to target cognitive impairment at its source in the brain, informed by decades of research and validated through rigorous clinical programs. Driven by Akili’s belief that effective medicine can also be fun and engaging, Akili’s products are delivered through captivating action video game experiences. For more information, please visit www.akiliinteractive.com.
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 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 U.S. and in foreign markets, and any related restrictions or limitations of an approved product candidate, our ability to obtain or maintain adequate insurance coverage and reimbursement for EndeavorRx, our ability to manage our growth effectively and our expectations regarding the development and expansion of our business, the effect of uncertainties related to the ongoing COVID-19 pandemic, and other risks identified in our filings made with the Securities and Exchange Commission (SEC). We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.