TIDMPRTC
PureTech Health PLC
21 October 2020
21 October 2020
PureTech Health plc
PureTech Founded Entity Akili Announces Presentation of New
Outcome Data for Digital Therapeutic EndeavorRx(TM) in Paediatric
ADHD
Two-thirds of parents reported real-world improvements in
child's ADHD-related impairments following two months of treatment,
both when used alone and alongside stimulants
Improvements in attention during treatment were associated with
improvements in math and reading performance
Data across four clinical trials consistently demonstrate over
one-third of children with ADHD no longer showed attention
impairment on at least one measure of objective attention
PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a
clinical-stage biotherapeutics company dedicated to discovering,
developing and commercialising highly differentiated medicines for
devastating diseases, is pleased to note that its Founded Entity,
Akili, today announced multiple data presentations on
EndeavorRx(TM) (see prescribing information below), including
results from the STARS-Adjunct trial, a multi-site open-label study
designed to evaluate the impact of EndeavorRx(TM) on impairments in
daily life in children with attention-deficit/hyperactivity
disorder (ADHD) and inform prescribing practices . Also presented
were analyses across four clinical trials of EndeavorRx, evaluating
the impact of treatment on children's attention function compared
to normative ranges. The data were presented for the first time
this week at the American Academy of Child and Adolescent
Psychiatry (AACAP) 2020 Virtual Annual Meeting.
The full text of the announcement from Akili is as follows:
Researchers Present New Outcome Data for Akili Digital
Therapeutic EndeavorRx(TM) in Paediatric ADHD
Two-thirds of parents reported real-world improvements in
child's ADHD-related impairments following two months of treatment,
both when used alone and alongside stimulants
Improvements in attention during treatment were associated with
improvements in math and reading performance
Data across four clinical trials consistently demonstrate over
one-third of children with ADHD no longer showed attention
impairment on at least one measure of objective attention
BOSTON, Mass - October 21, 2020 - Akili today announced multiple
data presentations on EndeavorRx(TM) (see prescribing information
below), including results from the STARS-Adjunct trial, a
multi-site open-label study designed to evaluate the impact of
EndeavorRx(TM) on impairments in daily life in children with
attention-deficit/hyperactivity disorder (ADHD) and inform
prescribing practices . Also presented were analyses across four
clinical trials of EndeavorRx, evaluating the impact of treatment
on children's attention function compared to normative ranges. The
data were presented for the first time this week at the American
Academy of Child and Adolescent Psychiatry (AACAP) 2020 Virtual
Annual Meeting.
"The STARS-Adjunct study provides further evidence for
physicians on the use of EndeavorRx in clinical practice, including
duration of treatment and use alongside traditional ADHD
medications," said Anil Jina, MD, Chief Medical Officer of Akili.
"Building on the improvements in objective measures of attention
demonstrated in our prior clinical studies of EndeavorRx, these
data help show the benefits of treatment seen by parents assessing
their child's ADHD-related impairments in everyday life."
Key results across the presentations include:
-- Improvements in the ADHD Impairment Rating Scale (IRS) were
statistically significant compared to baseline and were similar in
magnitude regardless of whether or not children were taking
stimulant medication(1) : B oth children taking stimulants and
those not taking any ADHD medication demonstrated similar and
statistically significant improvements (children on stimulants:
mean improvement -0.7, p < 0.001; and children off stimulants:
mean improvement -0.5, p < 0.001).
-- Parent observations showed half of children responded to
treatment following one month of EndeavorRx use and improvements
remained stable for one month following treatment(2) : Half of
parents reported improvements in their child's ADHD-related
impairments in daily life following one month of EndeavorRx
treatment as measured by the IRS (responders/improvement of one
point or more on the IRS scale: 50.0%).
-- Improvements increased with longer duration of treatment,
with more than two-thirds of children responding to treatment
following two months of EndeavorRx use(2) : More than two-thirds of
parents reported improvements in their child's ADHD-related
impairments following a second month of treatment as measured by
the IRS (responders/improvement of one point or more the IRS scale:
68.3%).
-- Over one-third of children no longer showed attention impairment on at least one measure
of objective attention following treatment(3) : Analyses across
four studies in paediatric ADHD(4) showed that overall 34.5% of
children moved into the normative range on at least one TOVA
objective measure of attention following four weeks of EndeavorRx
treatment (N=296 children aged 8 to 15 years old with ADHD and TOVA
impairment at baseline).
-- Early exploratory evidence showed children who improved in attention functioning following
treatment also improved their math and reading skills(4) :
Performance on the Test of Silent Reading Efficiency and
Comprehension (TOSREC) and the Mathematics Fluency and Calculation
Tests (MFaCTS) improved in children whose Test of Variables of
Attention (TOVA) Attention Comparison Score (ACS/API) improved.
EndeavorRx is an FDA-cleared digital treatment for children
diagnosed with ADHD. 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 Test of
Variables of Attention (TOVA) of sustained and selective attention
and may not display benefits in typical behavioural symptoms, such
as hyperactivity. EndeavorRx should be considered for use as part
of a therapeutic programme that may include clinician-directed
therapy, medication, and/or educational programmes; which further
address symptoms of the disorder. EndeavorRx is not intended to be
used as a stand-alone therapeutic and is not a substitution for a
child's medication.
About the STARS-ADHD Adjunct Study
The STARS-ADHD Adjunct study (NCT03649074) was a three-month
open-label, multi-site study of AKL-T01 (EndeavorRx) in 206
paediatric participants aged 8-14 years with a diagnosis of ADHD,
across two cohorts: children who were taking ADHD stimulant
medications (n=130) and children who were not taking ADHD
medications (n=76) for the duration of the study. Children
completed one month of treatment with AKL-T01, followed by a
one-month pause and then another one-month treatment with AKL-T01.
The primary outcome measure of the study was the change from
baseline after one month in the Impairment Rating Scale (IRS) for
each cohort. Secondary outcome measures included the ADHD Rating
Scale (ADHD-RS), Test of Variables of Attention (TOVA), Clinical
Global Impression - Improvement Scale (CGI-I), as well as
exploratory outcomes of academic performance measures (TOSREC,
MFaCTS).
About EndeavorRx
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 personalise 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 optimised 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.
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 randomised, 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 commercialising 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,
is comprised of 24 products and product candidates, including two
that have received US Food and Drug Administration (FDA) clearance
and European marketing authorisation. All of the underlying
programmes 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.
Forward Looking Statement
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 EndeavorRx 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 US media
Allison Mead Talbot Ben Atwell, Rob Winder Stephanie Simon
+1 617 651 3156 +44 (0) 20 3727 1000 +1 617 581 9333
amt@puretechhealth.com ben.atwell@FTIconsulting.com stephanie@tenbridgecommunications.com
(1) Kollins S.H., Heusser A., Lutz J. (2020, Oct 12-24). A
Home-Based, Digital Treatment for Pediatric ADHD as Adjunct to
Stimulant Medication: Insights on Repeat Administration and the
Stability of Effects. [Conference poster]. Sixty-seventh Annual
Meeting of the American Academy of Child & Adolescent
Psychiatry (AACAP); Virtual.
(2) Childress, A.C., Lutz, J., Kollins, S.H. (2020, Oct 12-24).
AKL-T01, a Digital Treatment for Pediatric ADHD as an Adjunct to
Stimulant Medication: Response Rates with Repeat Administration.
[Conference poster]. Sixty-seventh Annual Meeting of the American
Academy of Child & Adolescent Psychiatry (AACAP); Virtual.
(3) Melmed R., Lutz J., Jina A. (2020, Oct 12-24). Improving
Objective Measures of Attention in Test of Variables of Attention
(TOVA) into Normative Ranges with AKL-T01, a Digital Treatment for
Attention in Pediatric ADHD. [Conference poster]. Sixty-seventh
Annual Meeting of the American Academy of Child & Adolescent
Psychiatry (AACAP); Virtual.
(4) Davis N., Lutz J., Kollins S.H. (2020, Oct 12-24). AKL-T01,
a Home-Based Digital Intervention as an Adjunct to Stimulant
Medication for Pediatric ADHD: Academic Performance and Relation to
Objective Measures of Attention. [Conference poster]. Sixty-seventh
Annual Meeting of the American Academy of Child & Adolescent
Psychiatry (AACAP); Virtual.
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