Nearly two-thirds of adolescents saw clinically
meaningful improvement in attention following treatment
Improvements were nearly three times as large
as those in the pivotal trial that supported EndeavorRx’s FDA
authorization for children with ADHD ages 8-12
Akili has filed with FDA for potential
EndeavorRx label expansion
Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company,
is presenting pivotal trial data on EndeavorRx® (AKL-T01) in
adolescents with attention-deficit/hyperactivity disorder (ADHD) at
the 2023 American Society of Clinical Psychopharmacology (ASCP)
Annual Meeting in Miami Beach on May 31, 2023, and at the Elevate
Psych Congress in Las Vegas on June 2-3, 2023. The poster
presentations highlight results of Akili’s STARS-ADHD-Adolescents
label expansion trial evaluating the efficacy and safety of
EndeavorRx in adolescents ages 13-17 with ADHD.
The multi-center open-label study enrolled 162 adolescents ages
13-17 with inattentive or combined-type ADHD. After four weeks of
treatment with EndeavorRx, trial participants saw significant
improvements across a wide range of clinical outcomes, including in
their attention and ADHD-related symptoms.
“The data being presented expand the evidence supporting the
safety and efficacy of EndeavorRx to improve attention and
functioning in adolescents with ADHD,” said Scott Kollins, Ph.D.,
chief medical officer of Akili. “Teenagers have been significantly
impacted by our current mental health crisis, yet face substantial
challenges in accessing effective treatment for ADHD. With our
ongoing label expansion strategy, we aim to advance ADHD care
management for people of all ages to break down these barriers and
get treatment into the hands of patients in need.”
In the STARS-ADHD-Adolescents trial, EndeavorRx demonstrated a
statistically significant improvement in adolescents’ attention
function as measured by a change in the Attention Comparison Score
(ACS) of the FDA-cleared Test of Variables of Attention (TOVA®),
the trial’s predefined primary efficacy endpoint. Nearly two-thirds
(66%) of adolescents met the prespecified definition of clinical
response on the TOVA-ACS. The magnitude of improvement in attention
function in teenagers was nearly three times larger than what was
observed in the STARS-ADHD pivotal trial in 8-12 year olds that
served as the basis for EndeavorRx’s FDA authorization. The mean
change from baseline on the TOVA-ACS in adolescents was 2.6
(SD=3.8; P < 0.0001) as compared to 0.93 (p<0.001) in 8-12
year olds. In exploratory responder analyses, 24.7% of participants
no longer had a measurable attention deficit following treatment,
achieving a TOVA-ACS of at least 0, which is in the normative
range.
There were also consistent clinical benefits seen across a range
of secondary measures of ADHD-related symptoms and functioning.
Adolescents using EndeavorRx saw significant improvement in the
Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS)
inattention subscale and total scale scores (p<0.0001 for both).
ADHD-RS is a clinician-administered questionnaire which uses
information collected from the child's caregiver. A prespecified
responder analysis also showed that 27.1% of adolescents in the
study demonstrated at least a 30% reduction in total scores on the
ADHD-RS following EndeavorRx treatment, a finding similar to the
STARS-ADHD trial in children 8-12 (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.
In the study, approximately half of the teenagers used
EndeavorRx by itself and the other half used it in conjunction with
stimulant medication. The benefits of EndeavorRx were comparable
whether it was used alone or along with stimulants.
Consistent with the favorable safety profile reported in
previous studies of EndeavorRx, the treatment was shown to be safe
in this study, with no serious adverse events observed. A total of
4 participants (2.5%) experienced any adverse events, all of which
were anticipated and mild or moderate, including: frustration
tolerance decreased (3 participants) and headache (1
participant).
EndeavorRx is currently authorized for use in 8-12 year olds
with ADHD. Based on these new data, Akili has filed with FDA to
expand its current EndeavorRx label to include 13-17 year olds. In
May, Akili announced topline data from a successful pivotal study
of EndeavorRx in adults with ADHD 18 years of age and older,
demonstrating that improvements in both objective measures of
attention and clinical outcomes surpassed those seen in both
pediatric and adolescent patient populations.
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
8-12 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, the 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 potential
expansion of our current pediatric market through our regulatory
filing with FDA to seek a potential label expansion for EndeavorRx
in ADHD to include adolescents ages 13-17. 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
EndeavorRx or our ongoing or planned clinical trials, or will be
insufficient to support regulatory submissions or support or
maintain marketing approval or label expansion 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/20230531005310/en/
Media: Julie DiCarlo SVP, Communications
PR@akiliinteractive.com
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