Clinical trial data show that 83% of adults
with ADHD experienced improved focus, and 73% reported improvement
in quality of life after EndeavorOTC treatment
Available nationwide without a prescription,
EndeavorOTC users can now access their personalized Focus Score and
track progress towards clinically-meaningful improvements in
attention.
Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company,
today announced that EndeavorOTC™, the mobile video game treatment
clinically proven to improve attention and focus in adults with
ADHD, is now available on Google Play™ for popular Android devices,
including most Samsung Galaxy and Google Pixel models. Out of the
estimated 11 million adults living with ADHD in the United States,
approximately 40% are Android users so we believe this release
represents a crucial step in offering an accessible non-drug
treatment option to adults with ADHD, particularly amid the
continued stimulant medication shortage and ongoing mental health
crisis.
EndeavorOTC is built on the same technology as Akili’s
EndeavorRx®, the world’s first and only FDA-authorized video game
treatment, for children 8-12 years old with ADHD. In a recent
clinical trial, EndeavorOTC significantly improved focus,
attention, and overall quality of life in adults struggling with
ADHD symptoms. On average, participants’ ability to focus improved
by 85%*; over one-third of participants no longer exhibited an
attention deficit following treatment*, and 73% of participants
reported quality of life improvements**.
“Video games are an established part of life for the majority of
American adults,” said Jon David, chief product officer of Akili.
“By delivering an ADHD treatment via video game, we believe we’re
tapping into established habits and making a clinically-proven
treatment more accessible and approachable than ever before. With
the launch of EndeavorOTC on Android, we’re continuing to break
down barriers to care, making our treatment available to millions
of adults who may benefit.”
The release of EndeavorOTC comes at a time when the ADHD
community faces continued challenges accessing care. Fueled by
manufacturing issues and record-high prescription rates, the
stimulant shortage continues and now affects multiple ADHD drugs.
Last month, the U.S. Food and Drug Administration (FDA) and the
Drug Enforcement Administration (DEA) issued a joint statement on
the ongoing nationwide shortage of stimulants for the treatment of
conditions such as ADHD, noting the FDA’s support of non-drug
treatment options including Akili’s EndeavorRx product.
The Android release follows EndeavorOTC’s release on the Apple
iOS App Store® in June 2023. EndeavorOTC now features Akili’s
recently released Focus Score, a new metric for users. Focus Score
provides a measurement of how quickly and accurately patients can
complete a task despite distractions during gameplay, assisting
with setting benchmarks and quantifying progress. A patient’s
personalized baseline Focus Score is calculated during treatment
onboarding, along with a target Focus Score that serves as a
treatment goal. In Akili’s recent adult ADHD clinical trial, Focus
Score improvements were directly related to improvement in
ADHD-related symptoms and overall quality of life—things like being
able to complete tasks or keep track of important items like your
wallet and keys.
For more information, visit EndeavorOTC.com. EndeavorOTC is
available for download without a prescription for adults 18 years
of age and older on Android’s Google Play or Apple’s App Store.
*As measured by an improvement ≥ 1.4 on the TOVA® ACS. Changes
in the Focus Score are statistically significantly related to
changes in TOVA and other outcomes. Treatment results may vary.
Internal data on file. **As measured by the validated Adult ADHD
Quality of Life Scale (AAQoL). Internal data on file.
About EndeavorOTC and EndeavorRx
Akili’s suite of cognitive treatment products for ADHD includes
EndeavorOTC and EndeavorRx.
EndeavorOTC is a digital therapeutic indicated to improve
attention function, ADHD symptoms and quality of life in adults 18
years of age and older with primarily inattentive or combined-type
ADHD. EndeavorOTC utilizes the same proprietary technology
underlying EndeavorRx, a prescription digital therapeutic indicated
to improve attention function in children ages 8-12. EndeavorOTC is
available under the U.S. Food and Drug Administration’s current
Enforcement Policy for Digital Health Devices for Treating
Psychiatric Disorders During the Coronavirus Disease 2019
(COVID-19) Public Health Emergency. EndeavorOTC has not been
cleared or authorized by the U.S. Food and Drug Administration for
any indications. It is recommended that patients speak to their
health care provider before starting EndeavorOTC treatment. No
serious adverse events have been reported in any of our clinical
studies. To learn more, visit EndeavorOTC.com.
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.
About Akili
Akili is pioneering the development of cognitive treatments
through game-changing technologies. Akili’s 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.
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: the ability of adults
to access and use EndeavorOTC; the ability of EndeavorOTC to
improve attention function, ADHD symptoms and quality of life in
adults with ADHD; and the growing need for ADHD treatment and
non-drug options. 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 will not continue or be repeated in EndeavorOTC or
our ongoing or planned clinical trials for this or any other
product, or will be insufficient to support regulatory submissions
or to obtain, support or maintain marketing approval in the United
States or other jurisdictions, or that long-term adverse safety
findings may be discovered; the risk that our products will not be
further developed or commercialized successfully; the timing and
results expected from our and our partners’ clinical trials and our
reliance on third parties for certain aspects of our business; our
ability to accurately estimate expenses, capital requirements, and
needs for additional financing; and other risks identified in our
current filings and any subsequent 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 hereof and should not be relied upon as representing the
company’s views as of any subsequent date. 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/20230921991014/en/
Investors: Santosh Shanbhag Chief Financial Officer
InvestorRelations@akiliinteractive.com Media: Caty Reid VP,
Marketing & Communications PR@akiliinteractive.com
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