TIDMPRTC
PureTech Health PLC
15 January 2020
15 January 2020
PureTech Health plc
PureTech Affiliate Akili Announces New AKL-T01 Study Achieved
Primary Endpoint in Children with ADHD
AKL-T01 showed statistically significant improvement in ADHD
Impairment Rating Scale (IRS), when used alone and as adjunct to
stimulants
Akili continues to pursue FDA clearance for AKL-T01 as a
potential treatment of inattention in paediatric ADHD
PureTech Health plc (LSE: PRTC) ("PureTech") is pleased to note
that its affiliate, Akili, today announced top-line results of its
multi-site open-label study (STARS-ADHD Adjunctive) to evaluate the
effects of AKL-T01 in children with Attention Deficit Hyperactivity
Disorder (ADHD) when used with and without stimulant medication.
The effects of increasing the duration of treatment were also
studied. The study achieved its predefined primary efficacy
outcome, demonstrating a statistically significant improvement in
the ADHD Impairment Rating Scale (IRS) from baseline after one
month of treatment (p<0.001) in both children taking stimulant
medications and in those not taking stimulants.
Eric Elenko, PhD, chief innovation officer at PureTech, said:
"We are pleased with these new results as they provide additional
support for AKL-T01 in paediatric ADHD - both as a monotherapy and
in combination with stimulant medications. This study also builds
on the previously reported cognition findings by demonstrating
efficacy on the IRS, which is a scale of ADHD-specific symptoms
that provides measures of the real-world consequences of ADHD
symptoms."
The STARS-ADHD Adjunctive study is the fifth clinical study
evaluating AKL-T01 in children with ADHD. In STARS-ADHD, AKL-T01
demonstrated a statistically significant improvement compared to
control (p=0.006) on the predefined primary endpoint, a composite
score from the Test of Variables of Attention (TOVA(R)), an
objective measure of attention, after one month of treatment.
Across all studies to-date, AKL-T01 has been shown to be safe and
well tolerated. 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 full text of the announcement from Akili is as follows:
Akili Study of AKL-T01 With and Without Stimulant Medication in
Children with ADHD Achieves Primary Efficacy Endpoint
AKL-T01 showed statistically significant improvement in ADHD
Impairment Rating Scale (IRS), when used alone and as adjunct to
stimulants
Parents and clinicians saw increased improvements with a longer
duration of AKL-T01 treatment
Akili continues to pursue FDA clearance for AKL-T01 as a
potential treatment of inattention in paediatric ADHD
BOSTON, Mass - January 15, 2020 - Akili Interactive ("Akili" or
"Company"), today announced top-line results of its multi-site
open-label study (STARS-ADHD Adjunctive) to evaluate the effects of
AKL-T01 in children with Attention Deficit Hyperactivity Disorder
(ADHD) when used with and without stimulant medication. The effects
of increasing the duration of treatment were also studied. The
study achieved its predefined primary efficacy outcome,
demonstrating a statistically significant improvement in the ADHD
Impairment Rating Scale (IRS) from baseline after one month of
treatment (p<0.001) in both children taking stimulant
medications and in those not taking stimulants.
STARS-ADHD Adjunctive is the first study to look at the efficacy
of AKL-T01 when used in combination with stimulant medications and
the first to evaluate AKL-T01 over a longer duration of treatment.
In the study, similar improvements were seen both in children
taking stimulant medications and in those not taking stimulants,
suggesting that the effect of AKL-T01 was independent of whether
the children were on or off ADHD medication. Additionally,
improvements increased after a second month of treatment, with both
parents and clinicians noticing additional improvement in these
children with a longer duration of treatment. AKL-T01 showed a
similar safety profile in this study as has been seen previously,
with no serious adverse events observed. Full analysis of the data
is underway, and results of the study will be presented at upcoming
scientific conferences and submitted for publication in
peer-reviewed journals.
"Following our successful pivotal STARS-ADHD study of AKL-T01 as
a potential treatment for inattention in children with ADHD not
taking stimulant medications, understanding the benefit of our
technology when used alongside ADHD medications has been a research
priority for us. Importantly, parents see improvements in their
children regardless of whether they are using the treatment alone
or alongside stimulants," said Eddie Martucci, CEO of Akili. "As we
continue to work toward FDA clearance for this novel therapeutic
for inattention in children with ADHD, these data and the benefits
expressed by parents and physicians in this study lend further
credence to the important role AKL-T01 can play in the treatment of
ADHD."
More than 5.5 million children diagnosed with ADHD struggle with
attention issues. Inattention and other "silent" cognitive issues
often go unrecognised in the face of other more overt disease
symptoms, yet they significantly impact daily functioning.
"Children with ADHD are joined by millions of others, both with and
without medical diagnoses, who experience challenges in their daily
lives due to inattention or other cognitive issues. We're committed
to driving greater awareness and recognition of the impact of these
cognitive issues and advancing novel approaches to help all those
affected," said Anil Jina, MD, Akili's Chief Medical Officer.
The three-month study enrolled 206 children, aged 8-14 years
with a diagnosis of ADHD. The children were separated into two
groups: one with children on stimulant medications and one with
children not taking ADHD medication. Both groups received a first
period of AKL-T01 treatment in the first month of the study,
followed by a pause in AKL-T01 treatment in the second month, and
then a second period of AKL-T01 treatment in the third month. The
primary efficacy outcome of the study was change in IRS, a
parent-reported clinician-administered ADHD impairment scale, after
one month of treatment. The study demonstrated statistically
significant improvement in the IRS from baseline after one month as
well as to the end of the three-month trial in both the children
on-stimulants and off-stimulants (both cohorts: p<0.001). The
second period of AKL-T01 treatment resulted in further increases in
efficacy on this primary outcome measure, beyond the effects
already seen after the first period of treatment. The magnitude of
improvement in IRS throughout the study was similar for children
independent of their ADHD medication use. Responder rates for IRS
(improvement of greater than 1 point or more on the IRS scale) were
41% and 55% at the end of the first period of treatment with
AKL-T01 in the off-stimulant and on-stimulant groups respectively.
This increased to 69% and 68% respectively by the end of the second
period of treatment. The treatment was safe and well-tolerated.
There were no serious adverse events and the most common
treatment-related adverse event reported was frustration.
The STARS-ADHD Adjunctive study is the fifth clinical study
evaluating AKL-T01 in children with ADHD. In December 2017, Akili
announced the results of a prospective, randomised, controlled,
one-month trial of AKL-T01 in 348 children with ADHD (STARS-ADHD)
who were not taking ADHD medications. In STARS-ADHD, AKL-T01
demonstrated a statistically significant improvement compared to
control (p=0.006) on the predefined primary endpoint, a composite
score from the Test of Variables of Attention (TOVA(R)), an
objective measure of attention, after one month of treatment. IRS
was also measured in the STARS-ADHD study; responder rates in the
STARS-ADHD study were similar to after one month of AKL-T01
treatment in the STARS-ADHD Adjunctive study and were statistically
greater than control. Across all studies to-date, AKL-T01 has been
shown to be safe and well tolerated. 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.
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 AKL-T01 and the STARS-ADHD Adjunctive Study
[NCT03649074]
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. The treatment is delivered through a captivating action
video game to help drive engagement and compliance.
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 STARS-ADHD Adjunctive study was a three-month
open-label, multi-site study of AKL-T01 in 206 paediatric
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 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 managed by the Duke Clinical Research
Institute.
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 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.
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.
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Contact:
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END
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