TIDMPRTC
RNS Number : 4644K
PureTech Health PLC
22 April 2020
22 April 2020
PureTech Health plc
PureTech Founded Entity Akili AnnouncesEAVOR(TM) Digital
Attention Treatment is Now Available for Children with Attention
Deficit Hyperactivity Disorder (ADHD) under FDA's COVID-19
Enforcement Discretion Guidance
PureTech Health plc (LSE: PRTC) ("PureTech," or the "Company")
is pleased to note that its Founded Entity, Akili, today announced
thatEAVOR(TM) (AKL-T01) is now available in the US for use by
children with attention deficit hyperactivity disorder (ADHD) and
their families. Akili is pursuing US Food and Drug Administration
(FDA) clearance ofEAVOR as a prescription treatment for use in
paediatric ADHD. In parallel, the current release ofEAVOR is in
response to new guidance from FDA recognising the need for access
to certain low-risk clinically-validated digital health devices for
psychiatric conditions, including ADHD during the COVID-19
pandemic. Akili is releasingEAVOR to families with children
diagnosed with ADHD and struggling with chronic attention
issues.EAVOR is downloaded from the App Store, and a separate
companion app is also available to help parents track and better
understand changes in their child's behaviour. For a limited time,
Akili is providing access toEAVOR to those who qualify at no
cost.
Daphne Zohar, founder and chief executive officer of PureTech,
said: "The launch of Akili'sEAVOR is a milestone for the field of
digital medicine and for the millions of children with ADHD. When
we founded Akili, the PureTech team envisioned an effective and
evidence-based, non-pharmacological treatment for ADHD that
physicians and parents would be comfortable supporting and children
would enjoy using . We believe the large body of data generated to
date supports this vision and distinguishesEAVOR as a first of its
kind, non-pharmaceutical digital treatment to help children address
inattentiveness, one of the most pervasive symptoms of ADHD.
"Today's launch also highlights the importance of telehealth, a
broad theme carried across several of our Founded Entities. Remote
treatment and monitoring enable patients to access support from the
comfort and safety of their own homes, removing one of the steepest
barriers to care. As the parent of a child with ADHD, I have been
eagerly awaiting this day and I am proud to be associated with
Akili andEAVOR."
The full text of the announcement from Akili is as follows:
Akili AnnouncesEAVOR(TM) Attention Treatment is Now Available
for Children with Attention Deficit Hyperactivity Disorder (ADHD)
under FDA's COVID-19 Enforcement Discretion Guidance
BOSTON, Mass - April 22, 2020 - Akili today announced
thatEAVOR(TM) (AKL-T01) is now available for use by children with
attention deficit hyperactivity disorder (ADHD) and their families.
Delivered through a captivating video game experience,EAVOR is a
digital treatment that has been shown in a rigorously designed and
conducted clinical research programme 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. Attention impairments are a
component of ADHD in more than 85% of children diagnosed and can
significantly impact daily functioning.
Akili is pursuing US Food and Drug Administration (FDA)
clearance ofEAVOR as a prescription treatment for use in paediatric
ADHD. In parallel, the current release ofEAVOR is in response to
new guidance from FDA recognising the need for access to certain
low-risk clinically-validated digital health devices for
psychiatric conditions including ADHD during the COVID-19
pandemic.
"The current environment is hard for any child. Increased stress
and upended schedules and routines have a direct impact on our
cognition, increasing our distractibility and making it harder to
stay focused and to be organised," said Scott Kollins, PhD,
professor of psychiatry, director of the ADHD Program at Duke
University School of Medicine. "For children with attention issues
associated with ADHD, their daily challenges are exacerbated and
many of their support systems are no longer accessible."
Akili is releasingEAVOR to families with children diagnosed with
ADHD and struggling with chronic attention issues. For a limited
time, Akili is providing access toEAVOR to those who qualify at no
cost.
"At Akili, we've been steadfast in our commitment to build a
future where effective medicine is not only easily accessible but
also can treat patients in an entirely new and engaging way," said
Eddie Martucci, PhD, chief executive officer of Akili. "During this
time of increased need, we're proud to be able to immediately offer
our new clinically validated digital medicine experience to the
ADHD community."
While often underrecognised in the face of more overt
externalising symptoms of ADHD, inattentiveness experienced by many
children living with ADHD can be substantial.
"The impact of inattentiveness on functioning in children with
ADHD is apparent to me on a daily basis in my practice. It affects
making and keeping friends, completing tasks, building confidence
and succeeding in school. In a clinical trial setting, I've
seenEAVOR have positive impacts on these areas, and my hope is that
this intervention could play a valuable role as part of an
integrated and comprehensive treatment approach for children with
attentional challenges," said Raun Melmed, MD, behavioral
pediatrician and director of Melmed Center, Scottsdale, Ariz. and
author of a series of books on mindfulness for children including
"Marvin's Monster Diary: ADHD Attacks!"
EAVOR is the centrepiece of the Endeavor Treatment System(TM) care
programme, which includesEAVOR, Akili Assist(TM) personal support
services, and the ADHD Insight(TM) companion app, designed to help
parents track and better understand changes in their child's
behaviour over time. Easily accessible from home,EAVOR is
downloaded from the App Store by families on their mobile devices
and does not require any additional equipment.
Driven by the core belief at Akili that effective medicine can
also be fun and engaging,EAVOR is delivered through an action video
game experience. UsingEAVOR, patients navigate a character through
different worlds while avoiding obstacles and collecting targets to
unlock new worlds and receive awards. The captivating experience
ofEAVOR is designed to drive engagement and compliance.
With neuroscience and technology as its foundation,EAVOR is
built on the Akili Selective Stimulus Management engine (SSME(TM) )
core technology, a proprietary technology designed for the targeted
activation of specific neural systems in the brain to treat
diseases with associated cognitive dysfunction. 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. The technology implements algorithms that adapt
in both real-time and between treatment sessions to automatically
adjust the difficulty level for a treatment experience that is
personalised to the needs of 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.
Clinical Studies ofEAVOR
Akili has rigorously testedEAVOR across five clinical trials,
which included more than 600 children diagnosed with ADHD. The
research programme included three studies in ADHD (STARS-ADHD,
STARS-Adjunct and ADHD-POC ) and two pilot studies in ADHD with
different comorbidities ( Sensory Processing Disorder and Autism
Spectrum Disorder ). The pivotal STARS-ADHD study was a
multi-centre, randomised, blinded, controlled study in 348 children
diagnosed with ADHD, and results were recently published in The
Lancet Digital Health journal. In the pivotal study,EAVOR showed a
statistically significant improvement compared to an
educational-style video game control (p=0.006) on a change in the
Attention Performance Index (API) of the Test of Variables of
Attention (TOVA(R)), a computerised test cleared by FDA to evaluate
the effects of interventions in ADHD. In the STARS-Adjunct
open-label study, statistically significant improvement was seen in
the IRS (a parent-reported clinician-administered scale of ADHD
impairments) from baseline to after 4-weeks of treatment in both
children on stimulants and off any ADHD medication. No serious
adverse events have been associated withEAVOR in any study to date.
Some study participants (9.3%) experienced non-serious
treatment-related adverse events withEAVOR, including frustration,
headache, dizziness, emotional reaction, nausea or aggression.
Access and Use ofEAVOR
The current release ofEAVOR is enabled by new guidance from FDA
in response to the COVID-19 public health emergency.EAVOR is
available today for qualified families with children diagnosed with
ADHD and struggling with chronic attention issues and who are
willing to commit to following theEAVOR instructions for use.EAVOR
is currently available for use on iOS devices. To check if they are
eligible, parents of children with ADHD can visit Akili's enrolment
site at GetEndeavor.com. Parents should contact a physician before
their child begins usingEAVOR.
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 has pioneered the development of
video game-based digital medicine to improve cognitive function.
Akili's flagship product, ENDEAVOR, is a digital treatment to
address inattention in children with attention deficit
hyperactivity disorder (ADHD). ENDEAVOR is currently available
under FDA's enforcement discretion policy for use during the
COVID-19 pandemic; it has not yet received FDA clearance. Akili's
patented technology serves as the foundation of its products and is
designed to directly activate the networks in the brain responsible
for cognitive function. 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 that
drive engagement and compliance. For more information, please visit
www.Akiliinteractive.com .
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 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.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
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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