TIDMPRTC
PureTech Health PLC
26 March 2021
26 March 2021
PureTech Health plc
PureTech Founded Entity Akili Announces the Results of
EndeavorRx(TM) Clinical Study in Pediatric ADHD Published in Nature
Digital Medicine
Data on the treatment's effect on daily functioning support
existing evidence showing improvements across objective measures of
attention
Significant improvements in impairments and symptoms seen by
parents in daily life, both when used alone and alongside stimulant
medication
Improvements observed by parents and clinicians increased with
longer duration of treatment and persisted one month following
treatment
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases , is pleased to note that its
Founded Entity, Akili Interactive (Akili) , today announced the
publication of full data from a multi-site open-label study (the
STARS Adjunct study) evaluating the impact of EndeavorRx(TM)
(AKL-T01) on symptoms and functional impairments in children with
attention-deficit/hyperactivity disorder (ADHD).
Statistically significant improvement was demonstrated in all
predetermined endpoints of the study, which included parent and
clinician ratings of children's ADHD symptoms and related
impairments in daily life. The results have been published in the
international peer-reviewed journal, Nature Digital Medicine.
The STARS Adjunct study data, along with data from four other
clinical studies of EndeavorRx in pediatric ADHD, were presented to
the U.S. Food and Drug Administration (FDA) and part of the data
package which led to FDA clearance of EndeavorRx(TM) in June
2020.
The full text of the announcement from Akili is as follows:
Results of Akili's EndeavorRx(TM) Clinical Study Published in
Nature Digital Medicine, Demonstrate Improvements in Pediatric ADHD
Impairments and Symptoms in Daily Life
Data on the treatment's effect on daily functioning support
existing evidence showing improvements across objective measures of
attention
Significant improvements in impairments and symptoms seen by
parents in daily life, both when used alone and alongside stimulant
medication
Improvements observed by parents and clinicians increased with
longer duration of treatment and persisted one month following
treatment
BOSTON - March 26, 2021 - Akili Interactive ("Akili" or
"Company"), today announced the publication of full data from a
multi-site open-label study (STARS Adjunct) evaluating the impact
of EndeavorRx (TM) (AKL-T01) on symptoms and functional impairments
in children with attention- deficit/hyperactivity disorder (ADHD).
Statistically significant improvement was demonstrated in all
predetermined endpoints of the study, which included parent and
clinician ratings of children's ADHD symptoms and related
impairments in daily life. The
results have been published in the international peer-reviewed journal, Nature Digital Medicine.
Building on the results of the STARS-ADHD pivotal study of
EndeavorRx published in The Lancet Digital Health in February 2020,
the STARS Adjunct study evaluated the safety and efficacy of
EndeavorRx when used alone and alongside stimulants. The study also
assessed the effect of increasing the duration of treatment.
Standard clinician ratings of impairments and symptoms were
measured, as well as ratings by parents of their children in daily
life. The STARS Adjunct study data, along with data from four other
clinical studies of EndeavorRx in pediatric ADHD, were presented to
the U.S. Food and Drug Administration (FDA) and part of the data
package which led to FDA clearance of EndeavorRx in June 2020.
"The results of this study highlight the impact EndeavorRx can
have on patients' day-to-day lives and show the potential benefits
of incorporating digital therapeutics into multifaceted treatment
plans, including those with traditional pharmacological
interventions," said Anil Jina, M.D., Chief Medical Officer of
Akili.
A change in the ADHD Impairment Rating Scale (IRS), a
parent-reported assessment scale of ADHD- specific impairments
observed in their child's day-to-day life, was the primary outcome
measure of the study. All children participating in the study
received the EndeavorRx treatment, with one group also taking
stimulant medications and the other not taking medications. Both
groups of children demonstrated statistically significant
improvements in the IRS compared to baseline (children on
stimulants: -0.7, p<0.001; children not on stimulants: -0.5,
p<0.001). Half of children (50.0%) were clinical responders to
treatment following one month of treatment and over two-thirds
(68.3%) of children showed a clinical response following two months
of treatment (clinical response pre-defined as IRS improvement of
one point or more).
"The findings from this latest study offer additional
information about the effectiveness of EndeavorRx in children
treated with front-line pharmacotherapy for ADHD," said Scott
Kollins, Ph.D., Professor of Psychiatry and Director of the ADHD
Program at the Duke University School of Medicine, faculty member
at the Duke Clinical Research Institute (DCRI), and lead author of
the publication. "As a clinician who works with children with ADHD,
I am happy to see these results from an innovative treatment that
can improve both symptoms and impairments in children with
ADHD."
Also measured were clinician-reported assessments of the ADHD
Rating Scale (ADHD-RS) and the mean clinical global impression of
improvement (CGI-I). Statistically significant improvements were
seen across both assessments in children, regardless of whether
they were using EndeavorRx alone or alongside stimulants. ADHD-RS
symptom response rates were similar for children both on and off
ADHD medication, with 27.2% of children responding to treatment
following one month of treatment and 45.3% following two months of
treatment (clinical response on ADHD-RS predefined as >=30%
reduction in symptoms).
The STARS Adjunct study also looked at the duration of effects
of EndeavorRx. Four weeks following treatment, ADHD-RS scores
remained significantly improved for participants in both children
who used EndeavorRx alone and those who used the treatment
alongside stimulants (all p<0.001).
The safety profile of EndeavorRx was consistent with that seen
in all previous clinical studies of the product; the treatment was
well-tolerated with no serious adverse events.
EndeavorRx has been studied in more than 600 children with ADHD
across five clinical trials, including a large, multicenter
prospective randomized controlled study. Based on the totality of
data from those studies which showed clinical benefit in attention
as measured by computer-based testing, academic performance
measures, and other assessment tools, EndeavorRx was cleared by the
U.S. Food and Drug Administration (FDA), making it the first
prescription treatment delivered through a video game.
EndeavorRx (TM) Indication and Overview
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 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.
EndeavorRx (AKL-T01) is built on the Akili Selective Stimulus
Management Engine (SSME(TM)) core technology, a proprietary
technology designed to target key attentional control systems in
the brain. SSME presents specific sensory stimuli and simultaneous
motor challenges designed to target and activate the neural systems
that play a key role in attention function while using adaptive
algorithms to personalize the treatment experience for each
individual patient. This enables second by second monitoring of
patient progress completing the treatment sessions, and
continuously challenges each patient to an optimized level,
encouraging patients to improve their performance. Driven by the
core belief at Akili that effective medicine can also be fun and
engaging, EndeavorRx is delivered through an action video game
experience. The captivating experience of EndeavorRx is designed to
drive engagement and compliance. To learn more about EndeavorRx,
please visit www.EndeavorRx.com .
STARS Adjunct [NCT03649074] Study Overview
The STARS Adjunct study was a three-month open-label, multi-site
study of AKL-T01 in 206 pediatric participants aged 8-14 years with
a diagnosis of ADHD. AKL-T01 treatment was evaluated across two
groups of participants, one group of children who were taking ADHD
stimulant medications (n=130) and one group of children who were
not taking ADHD medications (n=76) for the duration of the study.
The primary outcome measure of the study was the change from
baseline in the ADHD Impairment Rating Scale (IRS) for each cohort
after one month. Secondary and exploratory outcome measures
included the ADHD Rating Scale (ADHD-RS), Tests of Variables of
Attention (TOVA), Clinical Global Impression - Improvement Scale
(CGI-I), as well as academic measures. The study was conducted by
the DCRI.
Primary Endpoint: ADHD Impairment Rating Scale (IRS)
The Impairment Rating Scale (IRS) is a parent-reported
clinician-administered scale of ADHD-specific impairment across
domains such as social functioning, academic progress and
self-esteem, including an overall impairment. The domains of
ADHD-specific impairment assessed by the IRS correspond to DSM
criteria of impaired functioning in social or academic areas for
ADHD. The assessment provides measures of real-world consequences
of ADHD symptoms.
About Akili
Akili is combining scientific and clinical rigor with the
ingenuity of the tech and entertainment industries to challenge the
status quo of medicine. Akili is pioneering the development of
digital treatments and care solutions to help people affected by
cognitive impairments. Akili's treatments are designed to directly
activate the networks in the brain responsible for cognitive
function and have been rigorously tested in extensive clinical
studies, including prospective randomized, controlled trials.
Driven by Akili's belief that effective medicine can also be fun
and engaging, Akili's treatments are delivered through captivating
action video game experiences. For more information, please visit
www.AkiliInteractive.com .
EndeavorRx(TM) is a registered trademark of Akili Interactive
Labs, Inc.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
intractable cancers, lymphatic and gastrointestinal diseases,
central nervous system disorders and inflammatory and immunological
diseases, among others. The Company has created a broad and deep
pipeline through the expertise of its experienced research and
development team and its extensive network of scientists,
clinicians and industry leaders. This pipeline, which is being
advanced both internally and through PureTech's Founded Entities,
as of the date of PureTech's most recently filed Registration
Statement on Form 20-F, was comprised of 24 therapeutics and
therapeutic candidates, including two that have received FDA
clearance and European marketing authorization. All of the
underlying programs and platforms that resulted in this pipeline of
product candidates were initially identified or discovered and then
advanced by the PureTech team through key validation points based
on the Company's unique insights into the biology of the brain,
immune and gut, or BIG, systems and the interface between those
systems, referred to as the BIG Axis.
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, including statements that relate to the
company's future prospects, developments, and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks and uncertainties that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, our expectations regarding the potential therapeutic benefits
of our therapeutic candidates, expectations regarding the results
from Akili's STARS Adjunct study evaluating EndeavorRx(TM)
(AKL-T01), its potential therapeutic benefits and those risks and
uncertainties described in the risk factors included in the
regulatory filings for PureTech Health plc. 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, neither the company
nor any other party intends to update or revise these
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
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