Akili Launches EndeavorRx® Expedition - A Direct-to-Patient Product Registry
21 September 2022 - 9:00PM
Business Wire
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.
About Akili
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220921005327/en/
Megan Branch mbranch@akiliinteractive.com
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