TIDMPRTC
RNS Number : 4600X
PureTech Health PLC
06 May 2016
6 May 2016
PureTech Health plc
Akili Interactive Labs Opens Enrolment for Pivotal Trial of
Novel ADHD Treatment
Large-scale trial designed to validate digital medicine
treatment for children with ADHD
PureTech Health plc ("PureTech", LSE: PRTC), a
cross-disciplinary healthcare company tackling fundamental
healthcare needs in disruptive ways, notes that Akili Interactive
Labs, Inc. ("Akili"), a company developing a novel,
non-pharmacological technology for cognitive disorders, today
announced open enrolment for its pivotal STARS-ADHD trial. The
trial will evaluate the safety and efficacy of the company's
proprietary platform, Project: EVO, for the treatment of children
with Attention Deficit Hyperactivity Disorder (ADHD).
Daphne Zohar, Co-Founder and Chief Executive Officer at
PureTech, said: "About 75% of young children with ADHD are taking
medication, yet there is a growing demand for non-pharmacological
interventions. With the initiation of open enrolment for this
pivotal trial, Akili is another step closer to bringing this
technology from the lab of Dr. Adam Gazzaley at the University of
California, San Francisco, to children with ADHD."
The full text of the announcement from Akili is as follows:
Akili Interactive Labs Opens Enrolment for Pivotal Trial of
Novel ADHD Treatment
Large-scale trial designed to validate digital medicine
treatment for children with ADHD
BOSTON, Massachusetts, May 6, 2016 - Akili Interactive Labs,
Inc. ("Akili"), a company developing a novel, non-pharmacological
technology for cognitive disorders, today announced open enrolment
for its pivotal STARS-ADHD trial. The trial will evaluate the
safety and efficacy of the company's proprietary platform, Project:
EVO, for the treatment of children with Attention Deficit
Hyperactivity Disorder (ADHD). This large-scale pivotal trial marks
an important inflection point in the advancement of digital
medicine as a clinically-validated treatment for diagnosed patient
populations.
ADHD is a neurological condition marked by inattention and/or
hyperactivity-impulsivity, and though about 75 percent of young
children with ADHD receive medication, there is a growing demand
for non-pharmacological interventions.
The mechanics of the Project: EVO platform are designed to
directly target an individual's core ability to process multiple
streams of information, which has the potential to change specific
neural networks and improve attention, inhibition and working
memory. STARS-ADHD is a double-blind, randomised, controlled,
parallel-group, interventional trial to evaluate the effects of
Project: EVO on attentional functioning and symptoms in
ADHD-diagnosed children. In a recent open-label study, Project: EVO
improved attention, inhibition and working memory in children with
ADHD. Akili seeks to further validate the benefits of Project: EVO
through the STARS-ADHD pivotal trial, which has been in piloting
phase since November. If the STARS-ADHD trial meets its endpoints,
the company plans to seek approval from the United States Food and
Drug Administration for this potential first-in-class treatment.
Akili has been conducting multiple clinical trials of its platform
across a variety of patient populations including autism spectrum
disorder (in collaboration with Autism Speaks), depression,
Alzheimer's disease (in collaboration with Pfizer, Inc.) and
traumatic brain injury, and it is also actively exploring clinical
collaborations in other neurodegeneration indications.
"Project: EVO has demonstrated strong clinical potential in
children with ADHD," said Eddie Martucci, Ph.D., Co-founder and
Chief Executive Officer of Akili. "The high-bar and rigor of a
pivotal trial is an important next step toward clinically
validating Project: EVO as a treatment. This validation is critical
for doctors, patients and parents to have confidence in the safety
and efficacy of this drug-free approach."
The STARS-ADHD study aims to enrol a minimum of 300 children
aged 8 to 12 years who have been diagnosed with ADHD. Eligible
individuals include those who are either not currently being
treated with pharmaceutical interventions, or are being treated
with a methylphenidate or amphetamine-based therapy and are willing
and deemed appropriate to discontinue use for the duration of the
study. Participants, who will be enrolled at up to ten sites across
the United States, will use the intervention software at home on a
tablet device for 4 weeks. After the 4-week period, an in-clinic
assessment will measure changes from baseline on a continuous
performance test, a standard measure of attention and impulsivity.
In addition to this primary outcome, several secondary outcomes -
including those measuring symptom relief, memory, function and
impairment - will be examined.
"Project: EVO has shown early promise to help improve attention
and neurocognition in cognitive disorders like ADHD," said
STARS-ADHD study principal investigator, Scott Kollins, Ph.D.,
M.S., Professor of Psychiatry and Director of the ADHD Program,
Duke University School of Medicine. "We look forward to enrolling
patients and advancing the study and validation of this potential
new treatment option for young patients with ADHD."
About Project: EVO
Akili's lead product candidate, Project: EVO, is based on a
platform technology exclusively licensed from the lab of Dr. Adam
Gazzaley at the University of California, San Francisco. The
mechanics of the platform are designed to directly target an
individual's core neurological ability to process multiple streams
of information, which has the potential to improve problem solving,
working memory and self-regulation. The innovative technology can
adapt difficulty automatically in real-time, allowing individuals
of wide-ranging ability levels to interact with the product without
the need for physician calibration. Akili is currently conducting
multiple clinical trials of its digital medicine platform across a
variety of patient populations, including paediatric ADHD, autism
spectrum disorder (in collaboration with Autism Speaks),
depression, Alzheimer's disease (in collaboration with Pfizer,
Inc.) and traumatic brain injury.
About Akili Interactive Labs
Akili is building clinically validated cognitive treatments and
assessments that are delivered in an action video game interface.
Leveraging medical-grade science and consumer-grade software
technology, the company is seeking to produce a new type of
healthcare product that is both highly-effective and
highly-engaging. The company was founded by PureTech Health
(PRTC.L), together with leading neuroscientists and game designers.
Akili has garnered investment from Shire PLC and has strategic
partnerships with Pfizer Inc. and Autism Speaks.
PureTech Health plc (PRTC.L) owns approximately 63% of the
company on a diluted basis (assuming the investment of the second
tranche of the January 2016 financing round).
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is a
cross-disciplinary healthcare company developing innovative
products that could improve the lives of billions of patients.
PureTech is focused on areas of growing scientific and technical
insights that it believes are at an important inflection point,
including the central nervous, gastro-intestinal and immune
systems, and the interactions and signalling between them. PureTech
has a pipeline of more than 30 programmes and has approximately 20
clinical studies across its pipeline, targeting multi-billion
dollar market opportunities. PureTech's advanced programmes include
five with human proof-of-concept and multiple with pivotal or
registration study readouts in the next two years. PureTech's
leading team and board, along with an advisory network of more than
60 expert founder-scientists and advisors across multiple
disciplines, gives PureTech access to potentially ground-breaking
science and technological innovation. With healthcare undergoing
major transformation, PureTech believes it is well positioned to
develop and launch medicines for the 21st century. For more
information, visit http://www.puretechhealth.com and connect with
us on Twitter.
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.
Enquiries
PureTech
Allison Mead, Associate Director, +1 617 651
Communications and Investor Relations 3156
FTI Consulting (Communications adviser
to PureTech)
Ben Atwell +44 (0) 20
Matthew Cole 3727 1000
This information is provided by RNS
The company news service from the London Stock Exchange
END
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