TIDMPRTC
RNS Number : 0347Q
PureTech Health PLC
16 June 2020
16 June 2020
PureTech Health plc
PureTech Founded Entity Akili Announces FDA Clearance of
EndeavorRx(TM) for Children with ADHD, the First Prescription
Treatment Delivered Through a Video Game
Shown to improve attention function, EndeavorRx is backed by
data from five clinical studies, including a prospective,
randomised controlled trial
EndeavorRx is the second product developed from PureTech's
unique R&D model to achieve FDA clearance
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 announce that its Founded
Entity, Akili, has been granted US Food and Drug Administration
(FDA) clearance for EndeavorRx (TM) (AKL-T01) as a prescription
treatment for children with attention-deficit/hyperactivity
disorder (ADHD). Delivered through a captivating 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. See full indication below. Persistent
attention issues have a significant impact on the daily lives of
millions of people. Attention impairments are a key component of
ADHD for many children.
Daphne Zohar, founder and chief executive officer of PureTech
said: "The FDA clearance of EndeavorRx is a tremendous milestone as
it represents an entirely new class of medicine for children and
their families. EndeavorRx is the first digital therapeutic
intended to improve symptoms associated with ADHD, and it is also
the first game-based therapeutic to be granted marketing
authorisation by the FDA for any type of condition. EndeavorRx is
now the second product developed from PureTech's unique R&D
model to receive FDA clearance and is further validation of our
approach to inventing, identifying, and advancing truly innovative
medicines for patients."
E ndeavorRx was granted clearance based on data from five
clinical studies in more than 600 children diagnosed with ADHD,
including a prospective, randomised, controlled study published in
The Lancet Digital Health journal, which showed EndeavorRx improved
objective measures of attention in children with ADHD. After four
weeks of EndeavorRx treatment, one-third of children no longer had
a measurable attention deficit on at least one measure of objective
attention. Further, about half of parents saw a clinically
meaningful change in their child's day-to-day impairments after one
month of treatment with EndeavorRx; this increased to 68% after a
second month of treatment. Improvements in ADHD impairments
following a month of treatment with EndeavorRx were maintained for
up to a month.
EndeavorRx was reviewed through FDA's de novo pathway and its
clearance creates a new class of digital therapeutics. EndeavorRx
is designed to directly target and activate neural systems through
the presentation of sensory stimuli and motor challenges to improve
cognitive functioning. The EndeavorRx treatment will be available
with a prescription to families soon.
EndeavorRx is the second product developed from PureTech's
unique R&D model to achieve FDA clearance. In April 2019,
Gelesis announced the FDA clearance of Plenity(TM) as an aid in
weight management in overweight and obese adults with a BMI of
25-40 kg/m(2) , when used in conjunction with diet and exercise.
Gelesis also recently received approval to market Plenity in
Europe. For the safe and proper use of Plenity, refer to the US
Instructions for Use or the EU Instructions for Use .
The full text of the announcement from Akili is as follows:
Akili Announces FDA Clearance of EndeavorRx(TM) for Children
with ADHD, the First Prescription Treatment Delivered Through a
Video Game
Shown to improve attention function, EndeavorRx is backed by
data from five clinical studies, including a prospective,
randomised controlled trial
BOSTON, Mass - June 15, 2020 - Akili today announced that the
U.S. Food and Drug Administration (FDA) has granted clearance for
EndeavorRx (TM) (AKL-T01) as a prescription treatment for children
with attention-deficit/hyperactivity disorder (ADHD). Delivered
through a captivating 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. See full indication below. Persistent
attention issues have a significant impact on the daily lives of
millions of people. Attention impairments are a key component of
ADHD for many children yet are often overshadowed by more overt
symptoms of ADHD.
EndeavorRx was reviewed through FDA's de novo pathway and its
clearance creates a new class of digital therapeutics. EndeavorRx
is designed to directly target and activate neural systems through
the presentation of sensory stimuli and motor challenges to improve
cognitive functioning.
"We're proud to make history today with FDA's decision, said
Eddie Martucci, PhD, chief executive officer of Akili. "With
EndeavorRx, we're using technology to help treat a condition in an
entirely new way as we directly target neurological function
through medicine that feels like entertainment. Families are
looking for new ways to help their children with ADHD. With today's
decision by FDA, we're excited to offer families a
first-of-its-kind non-drug treatment option and take an important
first step toward our goal to help all people living with cognitive
issues."
E ndeavorRx was granted clearance based on data from five
clinical studies in more than 600 children diagnosed with ADHD,
including a prospective, randomised, controlled study published in
The Lancet Digital Health journal, which showed EndeavorRx improved
objective measures of attention in children with ADHD. After four
weeks of EndeavorRx treatment, one-third of children no longer had
a measurable attention deficit on at least one measure of objective
attention. Further, about half of parents saw a clinically
meaningful change in their child's day-to-day impairments after one
month of treatment with EndeavorRx; this increased to 68% after a
second month of treatment. Improvements in ADHD impairments
following a month of treatment with EndeavorRx were maintained for
up to a month.
"For children living with ADHD, improving their ability to focus
and resist distraction is critical to their daily functioning and
performance in school," said Elysa Marco, MD, cognitive and
behavioural child neurologist and Clinical Executive for
Neurodevelopmental Medicine at Cortica Healthcare. "Unlike
traditional ADHD medications, EndeavorRx is designed to
specifically target inattention. Based on the benefits my research
participants and patients have experienced, I am thrilled that
EndeavorRx is moving from the lab to the clinic to play an
essential role as part of a comprehensive treatment plan for
children with ADHD."
The EndeavorRx treatment will be available with a prescription
to families soon. Akili believes that cognitive impairments require
the same constant attention and care as with any other chronic
condition. EndeavorRx will be released as the centrepiece of the
Endeavor Care Program, which includes the EndeavorRx treatment and
Akili Care,(TM) a mobile tracking app and personal support services
for caregivers. Easily accessible from home, EndeavorRx is
downloaded from the App Store by families on their mobile devices
and does not require any additional equipment.
"The clearance of EndeavorRx marks the culmination of nearly a
decade of research and development and was fuelled by the
commitment of our team and collaborators to challenge the status
quo of medicine. This would not have been possible without the
dedication of our clinical research partners and hundreds of
families who gave their time and energy to participate in our
clinical trials," said Scott Kellogg, senior vice president of
medical devices at Akili.
For families who have accessed EndeavorRx through FDA's COVID-19
enforcement discretion guidance , Akili is committed to a seamless
transition for them to the prescription program as appropriate.
About EndeavorRx
EndeavorRx 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 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.
Clinical Evidence Supporting EndeavorRx
The EndeavorRx research program includes 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, EndeavorRx
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 with EndeavorRx in any study to
date. Some study participants (9.3%) experienced non-serious
treatment-related adverse events with EndeavorRx, including
frustration, headache, dizziness, emotional reaction, nausea or
aggression.
EndeavorRx Indication for Use
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 Tests 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.
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, EndeavorRx, is a prescription digital
treatment to address inattention in children with attention deficit
hyperactivity disorder (ADHD). 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 AkiliInteractive.com
.
EndeavorRx(TM) and Akili Care(TM) are trademarks or registered
trademarks 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 22 product candidates and two products that have
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 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
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END
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