- 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
- Akili has stopped recruitment in separate adult ADHD trial to
allow for earlier data analysis
Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company,
today announced topline results of the STARS-ADHD-Adolescents label
expansion study evaluating the efficacy and safety of EndeavorRxⓇ
(AKL-T01) in adolescents ages 13-17 with
attention-deficit/hyperactivity disorder (ADHD). The pivotal study
achieved its predefined primary efficacy outcome, showing
statistically significant improvement in attentional functioning
after four weeks of treatment. Consistent improvements were also
seen in a range of secondary measures of ADHD-related inattention
symptoms and functioning. EndeavorRx treatment was generally
well-tolerated, with no serious device-related adverse events
reported.
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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 Scott Kollins, Ph.D., chief medical officer of Akili.
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 U.S. Food and Drug
Administration (FDA) authorization in that age group. In the
STARS-ADHD-Adolescents study, nearly two-thirds (66%) of
adolescents met the prespecified definition of clinical response on
the TOVA-ACS and nearly a quarter (24.7%) moved into the
non-clinical, or normative, range. TOVA is a computerized test
cleared by FDA to assess attention deficits and evaluate the
effects of interventions in ADHD.
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 27.1% of all participants in the study
demonstrated at least a 30% reduction in total scores on the
ADHD-RS, a finding similar to the STARS-ADHD trial in children with
ADHD (24%). Statistically significant improvements were also
observed for parent and child ratings of attention improvement, as
well as parent ratings of function across a number of domains,
including peer relationships, academic functioning, behavioral
functioning, homework functioning, and self-esteem. Overall, 4
(2.5%) participants experienced a treatment-emergent adverse device
event (3 decreased frustration tolerance, 1 headache; all mild or
moderate). There were no serious adverse device events.
Akili plans to present full data from the STARS-ADHD-Adolescents
study at a future medical meeting, and the company will file for
EndeavorRx label expansion with FDA in 2023. As part of Akili’s
label expansion strategy for EndeavorRx, in addition to the study
in adolescents, the company has been conducting a separate pivotal
trial of EndeavorRx in adults with ADHD. As was previously noted
during the company’s last earnings call, recruiting for that adult
study has been slower than projected. Based on this strong clinical
data in adolescents and the desire to maximize capital efficiency,
Akili has stopped recruitment of the adult study with 224 patients
enrolled in order to analyze the trial data ahead of schedule.
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.
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: 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 the United States or other
jurisdictions, or that long-term adverse safety findings may be
discovered; the risk that AKL-T01 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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Julie DiCarlo SVP, Communications julie@akiliinteractive.com
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