TIDMPRTC
RNS Number : 7283Q
PureTech Health PLC
23 June 2020
23 June 2020
PureTech Health plc
PureTech Founded Entity Akili Receives Approval to Market
EndeavorRx(TM) in Europe as a Digital Treatment for Children with
ADHD
Approval of CE Mark enables the marketing of EndeavorRx in
European Economic Area member countries
Delivered through a video game experience, EndeavorRx has been
studied across five clinical studies including a large, randomised
controlled trial
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 that it has received a Conformité Européenne
( CE) Mark for EndeavorRx (AKL-T01) as a prescription-only digital
therapeutic software intended for the treatment of attention and
inhibitory control deficits in paediatric patients with Attention
Deficit Hyperactivity Disorder (ADHD). While EndeavorRx is not yet
available in Europe, the CE Mark enables Akili to market EndeavorRx
in European Economic Area (EEA) member countries. ADHD is one of
the most common psychiatric disorders in childhood and nearly five
per cent of children in Europe are diagnosed with the disorder.
The CE Mark follows last week's US Food and Drug Administration
(FDA) decision, which made EndeavorRx the first FDA-cleared
prescription treatment delivered through a video game and the first
game-based therapeutic to be granted marketing authorisation by the
FDA for any type of condition. With a near-term focus on launching
the EndeavorRx prescription treatment in the US, Akili is exploring
expansion opportunities in Europe as part of its global strategy.
In March 2019, Akili announced a strategic partnership with
Shionogi & Co., Ltd. to develop and commercialise EndeavorRx in
Japan and Taiwan.
Daphne Zohar, founder and chief executive officer of PureTech
said: "Akili's European marketing authorisation today is an
important milestone for families in Europe looking to help their
children with ADHD. This is on the heels of the exciting news of
Akili's FDA clearance last week and Gelesis' receipt of a European
CE Mark for Plenity(R) earlier this month. We are so proud that two
products developed from our unique R&D engine have now received
marketing authorisation in both the US and Europe."
The full text of the announcement from Akili is as follows:
Akili Announces CE Mark Approval of EndeavorRx(TM) Digital
Treatment for Children with ADHD
Approval enables the future marketing of EndeavorRx in European
Economic Area member countries
Delivered through a video game experience, EndeavorRx has been
studied across five clinical studies including a large, randomised
controlled trial
BOSTON, Mass - June 23, 2020 - Akili today announced that it has
received Conformité Européenne ( CE) Mark certification for
EndeavorRx (AKL-T01), as a prescription-only digital therapeutic
software intended for the treatment of attention and inhibitory
control deficits in paediatric patients with Attention Deficit
Hyperactivity Disorder (ADHD). ADHD is one of the most common
psychiatric disorders in childhood and nearly five per cent of
children in Europe are diagnosed with the disorder.
The CE Mark follows last week's US Food and Drug Administration
(FDA) decision , which made EndeavorRx the first FDA-cleared
prescription treatment delivered through a video game.
"Following our recent FDA clearance, the CE Mark is another
important milestone for Akili," said Anil Jina, MD, chief medical
officer of Akili. "This approval provides a path for the future
expansion into Europe and will allow us to offer a new non-drug
treatment option to families of children living with ADHD."
The CE Mark confirms that EndeavorRx meets quality standards for
design, manufacture and final inspection. While EndeavorRx is not
yet available in Europe, the certification enables Akili to market
EndeavorRx in European Economic Area (EEA) member countries . With
a near-term focus on launching the EndeavorRx prescription
treatment in the US, the company is exploring expansion
opportunities in Europe as part of its global strategy. In March
2019, Akili announced a strategic partnership with Shionogi &
Co., Ltd. to develop and commercialise EndeavorRx in Japan and
Taiwan.
EndeavorRx is built on the Akili Selective Stimulus Management
engine (SSME(TM) ) proprietary technology that 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.
Clinical Evidence Supporting EndeavorRx
E ndeavorRx has been studied across 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. 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.
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 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) is a registered trademark of Akili Interactive
Labs, Inc. Digital assets of EndeavorRx are available here for
download, credit Akili Interactive.
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 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 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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