Attention improved in more than 80 percent of
adults with ADHD, and over one-third of participants no longer
exhibited an attention deficit following treatment
Improvements in attention were nearly seven
times larger than those seen in the pivotal trial that supported
EndeavorRx’s FDA authorization for 8-12 year olds with ADHD
Nearly half of adults treated with EndeavorRx
met a prespecified threshold for clinically meaningful improvement
in their quality of life
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company noted today
that its Founded Entity, Akili, Inc. (Nasdaq: AKLI) (“Akili”), a
leading digital medicine company, announced topline results of the
STARS-ADHD-Adult clinical trial evaluating the efficacy and safety
of EndeavorRxⓇ (AKL-T01) in adults with
attention-deficit/hyperactivity disorder (ADHD). STARS-ADHD-Adult
was designed as a pivotal clinical trial to enable registration
with the U.S. Food and Drug Administration (FDA). The trial
demonstrated statistically significant improvement in attention
functioning after six weeks of treatment, achieving its predefined
primary efficacy outcome. Significant improvements were also seen
across a range of secondary and exploratory outcomes, including
clinical assessments of ADHD-related symptoms and a validated
measure of quality of life. EndeavorRx treatment was
well-tolerated, with minimal side effects and no serious
device-related adverse events reported.
The multi-center open-label study (NCT05183919) enrolled 221
adults, 18 years of age and older, with inattentive or
combined-type ADHD. Patients used the video game-based digital
treatment on a mobile device in their homes for six weeks. 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 six weeks of treatment (p<0.0001), the study’s
predefined primary efficacy outcome. The change from baseline on
the TOVA ACS was 6.46 points, which is more than twice as large as
the changes seen in the recent pivotal study in adolescents (2.64
points) and nearly seven times as large as the changes seen in
STARS-ADHD (0.93 points), a large randomized controlled trial of
children with ADHD ages 8-12 that served as the basis for
EndeavorRx’s FDA authorization in that age group. TOVA is a
computerized test authorized by the FDA to aid in the diagnosis of
ADHD and evaluate the effects of interventions in ADHD.
Akili plans to present full data from the STARS-ADHD-Adult study
at a future scientific meeting and will submit the data to the FDA
later this year.
The full text of the announcement from Akili is as follows:
Adults with ADHD See Significant
Improvements in Attention, ADHD Symptoms, and Quality of Life in
Clinical Trial of Akili’s EndeavorRx® Video Game-Based
Therapeutic
Attention improved in more than 80 percent of
adults with ADHD, and over one-third of participants no longer
exhibited an attention deficit following treatment
Improvements in attention were nearly seven
times larger than those seen in the pivotal trial that supported
EndeavorRx’s FDA authorization for 8-12 year olds with ADHD
Nearly half of adults treated with EndeavorRx
met a prespecified threshold for clinically meaningful improvement
in their quality of life
BOSTON—May 3, 2023 -- Akili, Inc. (Nasdaq: AKLI), a
leading digital medicine company, today announced topline results
of the STARS-ADHD-Adult clinical trial evaluating the efficacy and
safety of EndeavorRxⓇ (AKL-T01) in adults with
attention-deficit/hyperactivity disorder (ADHD). STARS-ADHD-Adult
was designed as a pivotal clinical trial to enable registration
with the U.S. Food and Drug Administration (FDA). The trial
demonstrated statistically significant improvement in attention
functioning after six weeks of treatment, achieving its predefined
primary efficacy outcome. Significant improvements were also seen
across a range of secondary and exploratory outcomes, including
clinical assessments of ADHD-related symptoms and a validated
measure of quality of life. EndeavorRx treatment was
well-tolerated, with minimal side effects and no serious
device-related adverse events reported.
Millions of American adults are diagnosed with ADHD, and recent
reports suggest that rates have risen in recent years. This is
magnified by the substantial challenges this large group of
patients face in accessing effective treatment.
EndeavorRx is currently authorized by the FDA for the treatment
of inattention in children ages 8-12 with ADHD (see full indication
below), and in January Akili announced topline data from a
successful pivotal study of EndeavorRx in adolescents with ADHD
ages 13-17. For both objective measures of attention and clinical
outcomes, the improvements observed in adults surpassed those in
both the pediatric and adolescent patient populations.
“Not only did the benefit of EndeavorRx in adults with ADHD
exceed what we’ve seen in kids and adolescents, adults using the
treatment experienced meaningful improvements in their quality of
life,” said Scott Kollins, Ph.D., chief medical officer of Akili.
“These data come at a critical time when there is growing demand
among adults with ADHD for safe, effective, and accessible non-drug
treatments. It is increasingly recognized that current available
options are not working, and/or are not available. We are deeply
committed to getting this treatment to patients as quickly as
possible. We are evaluating regulatory strategies and look forward
to sharing more soon.”
The multi-center open-label study (NCT05183919) enrolled 221
adults, 18 years of age and older, with inattentive or
combined-type ADHD. Patients used the video game-based digital
treatment on a mobile device in their homes for six weeks. 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 six weeks of treatment (p<0.0001), the study’s
predefined primary efficacy outcome. The change from baseline on
the TOVA ACS was 6.46 points, which is more than twice as large as
the changes seen in the recent pivotal study in adolescents (2.64
points) and nearly seven times as large as the changes seen in
STARS-ADHD (0.93 points), a large randomized controlled trial of
children with ADHD ages 8-12 that served as the basis for
EndeavorRx’s FDA authorization in that age group. TOVA is a
computerized test authorized by the FDA to aid in the diagnosis of
ADHD and evaluate the effects of interventions in ADHD.
Adults using EndeavorRx also showed significant improvement in
their ADHD symptoms, as measured by the clinician-administered
Attention Deficit Hyperactive Disorder Rating Scale-5 (ADHD-RS).
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 32.7% of all participants in the study
demonstrated at least a 30% reduction in total scores on the
ADHD-RS, surpassing findings in the STARS-ADHD-Adolescents study in
13-17 year olds with ADHD (27.1%) and the STARS-ADHD study in 8-12
year olds with ADHD (24%).
Nearly three-quarters (72.5%) of adults reported at least some
improvement in their quality of life as measured by the validated
Adult ADHD Quality of Life Scale (AAQoL), and nearly 50 percent
(45.8%) of adults met a prespecified threshold for clinically
meaningful improvement.
Overall, 11 of the participants in the trial (5%) reported a
treatment-emergent adverse device event, most commonly nausea
(1.8%) and headache (1.4%). There were no serious adverse device
events.
Additional study information and results:
- 83% patients demonstrated a clinical response to the treatment
on the TOVA-ACS (post hoc analysis as measured by at least a 1.4
improvement on the TOVA)
- More than one-third (36.6%) of adults with ADHD moved into the
non-clinical, or normative, range (TOVA ACS score of >0)
- Quality of life improvements seen included an increased ability
to complete projects and tasks on time, ability to balance multiple
projects at a time, and ability to keep track of important items
such as keys and wallet
- Approximately 70% of the adults with ADHD in the study were
women
- 40% of patients enrolled were taking ADHD medication; a similar
magnitude of effect was seen both in those taking stimulant
medications and in those not taking stimulants
Akili plans to present full data from the STARS-ADHD-Adult study
at a future scientific meeting and will submit the data to the FDA
later this year.
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 future regulatory submissions for the clearance of
AKL-T01 in expanded patient populations; the potential market
opportunity for AKL-T01; and the timing at which we may receive
regulatory clearance and bring AKL-T01 to market for expanded
patient populations. 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.
About PureTech Health PureTech is a clinical-stage
biotherapeutics company dedicated to giving life to new classes of
medicine to change the lives of patients with devastating diseases.
The Company has created a broad and deep pipeline through its
experienced research and development team and its extensive network
of scientists, clinicians and industry leaders that is being
advanced both internally and through its Founded Entities.
PureTech's R&D engine has resulted in the development of 27
therapeutics and therapeutic candidates, including two (Plenity®
and EndeavorRx®) that have received both US FDA clearance and
European marketing authorization and a third (KarXT) that is
expected to be filed soon for FDA approval. A number of these
programs are being advanced by PureTech or its Founded Entities in
various indications and stages of clinical development, including
registration enabling studies. All of the underlying programs and
platforms that resulted in this pipeline of therapeutic candidates
were initially identified or discovered and then advanced by the
PureTech team through key validation points.
For more information, visit www.puretechhealth.com or connect
with us on Twitter @puretechh.
Cautionary Note Regarding Forward-Looking Statements This
press release contains statements that are or may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
without limitation those statements that relate to the results of
the STARS-ADHD-Adult clinical trial and expectations related to the
timing of the filing of data to the FDA, and Akili’s and PureTech's
future prospects, development plans, and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks, uncertainties and other
important factors that could cause actual results, performance and
achievements to differ materially from current expectations,
including, but not limited to, the following: our history of
incurring significant operating losses since our inception; our
need for additional funding to achieve our business goals, which
may not be available and which may force us to delay, limit or
terminate certain of our therapeutic development efforts; our
limited information about and limited control or influence over our
Non-Controlled Founded Entities; the lengthy and expensive process
of preclinical and clinical drug development, which has an
uncertain outcome and potential for substantial delays; potential
difficulties with enrolling patients in clinical trials, which
could delay our clinical development activities; side effects,
adverse events or other safety risks which could be associated with
our therapeutic candidates and delay or halt their clinical
development; our ability to obtain regulatory approval for and
commercialize our therapeutic candidates; our ability to realize
the benefits of our collaborations, licenses and other
arrangements; our ability to maintain and protect our intellectual
property rights; our reliance on third parties, including clinical
research organizations, clinical investigators and manufacturers;
our vulnerability to natural disasters, global economic factors,
geo-political actions and unexpected events; and those additional
important factors described under the caption "Risk Factors" in our
Annual Report on Form 20-F for the year ended December 31, 2022
filed with the SEC and in our other regulatory filings. These
forward-looking statements are based on assumptions regarding the
present and future business strategies of the Company and the
environment in which it will operate in the future. Each
forward-looking statement speaks only as at the date of this press
release. Except as required by law and regulatory requirements, we
disclaim any obligation to update or revise these forward-looking
statements, whether as a result of new information, future events
or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20230503005978/en/
PureTech Public Relations
publicrelations@puretechhealth.com
Investor Relations IR@puretechhealth.com
EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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