TIDMPRTC
RNS Number : 9768D
PureTech Health PLC
25 February 2020
25 February 2020
PureTech Health plc
The Lancet Digital Health Publishes Akili AKL-T01 ADHD Pivotal
Study Results
First publication of complete results shows improvement across
both objective measures of attention and parent and clinician
ratings of ADHD symptoms and functional impairments
Study results suggest AKL-T01 could play an important role in
the treatment of paediatric ADHD, directly targeting attention
impairments
PureTech Health plc (LSE: PRTC) ("PureTech") is pleased to note
that its affiliate, Akili, has published the results from its
STARS-ADHD trial of AKL-T01, a digital therapeutic designed to
improve attention in children with attention-deficit/hyperactivity
disorder (ADHD), in The Lancet Digital Health journal. The
publication represents the first presentation of complete results
from the STARS-ADHD trial, a first-of-its-kind large, randomised,
multi-centre, controlled study of the company's foundational
technology and the first seminal trial in a series of recent and
ongoing studies of the attentional treatment. Results show AKL-T01
improved both objective measures and parent observations of
attention and functional impairments.
Eric Elenko, PhD, chief innovation officer at PureTech, said: "
These complete results provide compelling insights and further
validation for AKL-T01 for the treatment of inattention in children
with ADHD. It also builds on the recently reported findings from
Akili's STARS-ADHD Adjunctive study, which demonstrated additional
promise for AKL-T01 as both a monotherapy and in combination with
stimulant medications. It is exciting to see the mounting data for
AKL-T01 which validates its potential."
The STARS-ADHD study represents the company's largest clinical
trial of AKL-T01 which has to-date been studied across five
clinical trials including more than 600 children diagnosed with the
disorder. Further researching the clinical implications of the
attentional treatment on patients' daily lives, Akili recently
conducted the STARS-ADHD Adjunctive study evaluating AKL-T01 in
children with ADHD when used with and without stimulant medication
as well as evaluating the effects of increasing the duration of
AKL-T01 treatment. In the STARS-ADHD Adjunctive study, AKL-T01
showed a statistically significant improvement in the Impairment
Rating Scale (IRS) when used alone and as adjunct to stimulants,
and parents and clinicians saw increased improvements with a longer
duration of AKL-T01 treatment (nearly 70% saw improvements after
two months of treatment). Additional studies of AKL-T01 are
underway, including a study to measure frontal-midline theta (MFT)
power through electroencephalogram (EEG) in children with ADHD
before and after treatment with AKL-T01.
The full text of the announcement from Akili is as follows:
Akili Announces Publication of AKL-T01 ADHD Pivotal Study
Results in The Lancet Digital Health
First publication of complete results shows improvement across
both objective measures of attention and parent and clinician
ratings of ADHD symptoms and functional impairments
Study results suggest AKL-T01 could play an important role in
the treatment of paediatric ADHD, directly targeting attention
impairments
BOSTON, Mass - February 24, 2020 - Akili Interactive today
announced that results from the STARS-ADHD trial of AKL-T01, a
digital therapeutic designed to improve attention in children with
attention-deficit/hyperactivity disorder (ADHD), were published in
The Lancet Digital Health journal . The publication represents the
first presentation of complete results from the STARS-ADHD trial, a
first-of-its-kind large, randomised, multi-centre, controlled study
of the company's flagship technology and the first seminal trial in
a series of recent and ongoing studies of the attentional
treatment. Results show AKL-T01 improved both objective measures
and parent observations of attention and functional
impairments.
ADHD is a disorder marked by a persistent pattern of inattention
and/or hyperactivity-impulsivity that interferes with functioning
or development. Inattention is a key component of ADHD for many
children and can significantly impact daily functioning. However,
inattention and other "silent" cognitive issues often go
unrecognised in the face of other more overt disease symptoms.
"For children living with ADHD, inattention can lead to
significant impairments across domains, including school
performance, home life and interpersonal relationships, yet it is
often overshadowed by the more overt symptoms of the disorder and
is often not optimally addressed by standard treatments," said Dr
Scott Kollins, Professor of Psychiatry, Director of the ADHD
Program at Duke University School of Medicine, who was the Duke
Clinical Research Institute principal investigator on the study.
"Products that can specifically improve a child's inattention could
represent safe and easy to access interventions that have the
potential to play an important role in the overall treatment of
ADHD."
In the study of 348 children diagnosed with ADHD, AKL-T01 showed
improvements across a wide range of attention measures, from
objective measures of attention to how attention impacted daily
life and functioning. AKL-T01 showed a statistically significant
improvement compared to an educational-style video game control
(p=0.006) on the predefined primary endpoint, a change in the
Attention Performance Index (API) of the Test of Variables of
Attention (TOVA(R)). TOVA is a computerised test cleared by the US
Food and Drug Administration (FDA) to assess attention deficits and
evaluate the effects of interventions in ADHD. The mean (SD) change
from baseline on the TOVA API (a composite measure of attention
functioning) was 0.93 in the AKL-T01 group and 0.03 in the control
group. Forty-seven percent of children met the prespecified
clinical responder analysis for TOVA API improvement, which was
greater than control (47% vs 32%, p=0. 0058 ). In addition to the
improvement in the TOVA API, treatment with AKL-T01 resulted in
significantly greater improvements across other objective TOVA
attention-related measures (sustained attention, attentional
consistency, and long attentional lapses). Overall, after treatment
with AKL-T01, 36% of children moved into the normative range and no
longer showed an attention deficit in at least one aspect of
attention functioning, statistically greater than control (36% vs
21%, P=0.0027).
In addition to these objective measures of attention, the study
also looked at secondary outcome measures comparing AKL-T01 to
control on parent- and clinician-reported ADHD impairment and
symptom ratings scales, including the Impairment Rating Scale
(IRS), ADHD Rating Scale (ADHD-RS-IV - Total, Inattentive,
Hyperactive subscales), Clinical Global Impressions-Improvement
(CGI-I) and the Behavior Rating Inventory of Executive Function
(BRIEF). Children using AKL-T01 showed statistically significant
improvement across all measures. Though there was not a
statistically significant separation on the mean magnitude of
effect between AKL-T01 and control, there was a trend towards
differential improvement in IRS and ADHD-RS-Inattentive for
children using AKL-T01.
Responder analyses of these parent- and clinician-reported
measures showed a significantly greater proportion of children
benefiting from AKL-T01 versus control in the IRS, a
parent-reported scale of ADHD-specific impairments, (48% vs 37%,
P=0--049). Additionally, 56% of parents said the intervention
helped their child's attention in real life, and 73% of children
reported feeling an improvement in their attention when asked via
an exit survey. Analysis of the full set of responder analyses
showed a trend favoring AKL-T01 across every outcome measure.
Consistent with the favourable safety profile reported in
previous studies, AKL-T01 was shown to be safe in this study, with
no serious adverse events observed, suggesting that AKL-T01 could
safely be added to the standard of care. All adverse events
reported were mild, including frustration (3%) and headache
(2%).
"These results build upon the growing body of evidence of
AKL-T01's impact on attention and related impairments in children
with ADHD," said Dr Anil Jina, Chief Medical Officer at Akili.
"Inattention and other underrecognised cognitive impairments can
significantly impact daily functioning and quality of life. We're
committed to pursuing novel, safe and effective approaches to help
those affected."
The STARS-ADHD study represents the company's largest clinical
trial of AKL-T01 which has to-date been studied across five
clinical trials including more than 600 children diagnosed with the
disorder. Further researching the clinical implications of the
attentional treatment on patients' daily lives, Akili recently
conducted the STARS-ADHD Adjunctive study evaluating AKL-T01 in
children with ADHD when used with and without stimulant medication
as well as evaluating the effects of increasing the duration of
AKL-T01 treatment. In the STARS-ADHD Adjunctive study, AKL-T01
showed a statistically significant improvement in the IRS when used
alone and as adjunct to stimulants, and parents and clinicians saw
increased improvements with a longer duration of AKL-T01 treatment
(nearly 70% saw improvements after two months of treatment).
Additional studies of AKL-T01 are underway, including a study to
measure frontal-midline theta (MFT) power through
electroencephalogram (EEG) in children with ADHD before and after
treatment with AKL-T01.
About AKL-T01 and STARS-ADHD
AKL-T01 is a digital therapeutic being evaluated as a potential
treatment for inattention in children living with ADHD. AKL-T01 is
built on Akili's Selective Stimulus Management engine (SSME(TM))
core technology, which presents a range of specific stimuli
designed to target and activate the fronto-parietal network in the
brain, known to play a key role in cognitive function and
attention. SSME has been shown to improve measures of attention in
a dozen different indications and has been studied in more than 30
clinical trials. The treatment is delivered through a captivating
action video game to help drive engagement and compliance. Akili
filed for clearance of AKL-T01 for the treatment of children with
ADHD with the United States Food and Drug Administration (FDA) in
2018. Clearance has not yet been granted, and Akili continues to
work with FDA in an effort to make the product available for
children living with ADHD as soon as possible.
The STARS-ADHD pivotal study of AKL-T01 was a randomised,
double-blind, active-controlled study conducted across 20 sites.
The study enrolled 348 children and adolescents ages 8-12 diagnosed
with ADHD. Patients were randomised 1:1 to AKL-T01 or an active
control. Both groups used the treatment/control at home on a tablet
device for four weeks. The control application was deployed in the
same format as AKL-T01, a mobile tablet, mimicked the reward and
engagement of AKL-T01, and had an expectation of benefit equivalent
to AKL-T01. After the four-week period, an in-clinic assessment
measured changes from baseline. The primary endpoint of the study
was change in the Attention Performance Index (API), a composite
score from the Test of Variables of Attention (T.O.V.A.(R)), an
FDA-cleared continuous performance test measuring sustained
attention and inhibitory control. Secondary outcomes included
subjective parent- and clinician-reported behavioral ratings. The
study was managed by Duke Clinical Research Institute.
About TOVA, IRS and ADHD-RS
The Test of Variables of Attention (T.O.V.A.(R)) is an objective
FDA-cleared continuous performance test that measures the key
components of attention and inhibitory control. The T.O.V.A.(R) is
used by qualified healthcare professionals as an aid in the
assessment of attention deficits, including
attention-deficit/hyperactivity disorder (ADHD), in children and
adults.
The Impairment Rating Scale (IRS) is a parent-reported scale of
ADHD-specific impairment across domains such as social functioning,
academic progress and self-esteem, including an overall impairment
rating. 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.
The ADHD Rating Scale (ADHD-RS) obtains parent ratings regarding
the frequency of ADHD symptoms based on DSM-IV criteria. Parents
are asked to determine symptomatic frequency that describes the
child's home behavior. The scale consists of two subscales:
inattention and hyperactivity-impulsivity.
About Akili
Akili is combining scientific and clinical rigour 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 rigourously 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 .
About PureTech Health
PureTech is a clinical stage biotechnology 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 affiliates, is comprised of 23 product
candidates and one product that has been cleared by the US Food and
Drug Administration (FDA). 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, 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 Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
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END
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