TIDMPRTC
PureTech Health PLC
06 April 2017
6 April 2017
PureTech Health plc
PureTech's Akili Announces Results from a Project EVO(TM) Pilot
Study Demonstrating Improved Cognitive Control in Children with
Sensory Processing Dysfunction and Attentional Deficits
Results show neurological changes in prefrontal cortex,
providing additional evidence of targeted neurological mechanism of
proprietary technology platform
Study published by collaborators at the University of California
San Francisco
PureTech Health plc ("PureTech", LSE: PRTC), an advanced,
clinical-stage biopharmaceutical company, announced results from a
Project: EVO(TM) pilot study conducted by collaborators at the
University of California San Francisco (UCSF) and published in PLOS
ONE. The study found that Akili Interactive Labs' (a subsidiary of
PureTech Health) digital treatment candidate Project: EVO(TM)
improved cognitive control test scores of neurotypical children and
children with Sensory Processing Dysfunction (SPD) both with and
without attention impairments. Importantly, treatment with Akili's
Project: EVO(TM) also produced neurological changes in the
prefrontal cortex of the brain and improved attention symptoms of
children with SPD and inattention/hyperactivity.
Daphne Zohar, Co-Founder and Chief Executive Officer at PureTech
Health, said: "At PureTech Health we are committed to exploring and
understanding the full potential of our programmes through pilot
and mechanistic studies with our academic collaborators. The
results from this study are encouraging and positive, as they
provide additional support for the targeted neurological mechanism
of our proprietary Akili technology platform."
The full text of the announcement from Akili is as follows:
Akili Announces Results from Pilot Study Showing Treatment with
Project EVO(TM) Improves Cognitive Control in Children with Sensory
Processing Dysfunction and Attentional Deficits
Results show neurological changes in prefrontal cortex,
providing additional evidence of targeted neurological mechanism of
proprietary technology platform
BOSTON and SAN FRANCISCO, April 5, 2017 - Akili Interactive
Labs, Inc. ("Akili"), today announced results from a pilot study,
conducted by collaborators at the University of California San
Francisco ("UCSF"), evaluating the efficacy and possible
neurological mechanisms of Project: EVO(TM) , a digital treatment
being developed by Akili, in children with Sensory Processing
Dysfunction (SPD) with and without attention impairments compared
to typically developing children. Improvements on tests of
cognitive control were observed in all groups, but the children
with SPD and inattention/hyperactivity showed greater improvement
in the Vanderbilt Assessment Scale as well as neurological changes
in the prefrontal cortex of the brain. The results, published in
PLOS ONE, provide additional evidence of a neurological mechanism
underlying treatment response, and underscore the potential of a
new kind of neurological targeting approach to treat patients based
on specific clinical features.
In the open-label pilot study, 57 children received at-home
treatment with Project: EVO for four weeks and subsequently
underwent post-treatment cognitive, behavioural, and neurological
assessment. Although all children showed improvement in measures of
cognitive control after training, only the children with SPD and
inattention showed statistically significant improvements in real
world function using the Vanderbilt Assessment (n=20; p<0.001),
a gold-standard parent-rating scale of real-world symptoms and
function. Furthermore, a stimulus-locked EEG measure characterising
the brain's immediate response to specific stimuli showed robust
change in the SPD+IA group (p<0.001). After treatment, 33% of
this group showed a reduction of parent-reported symptoms large
enough that they no longer met the clinical criteria for
inattention. Follow-up analyses 9 months later showed maintenance
of the parent-reported benefits that correlated with the
neurological signal related to how the brain's prefrontal cortex
processes and controls incoming sensory information (p=0.042).
"These findings are quite exciting given that they both
reproduce critical elements of the study of this technology in
older adults and suggest that this treatment approach can have
powerful effects across the lifespan and in distinct populations
with specific cognitive deficits," said Joaquin A. Anguera, PhD,
Assistant Professor in the Departments of Neurology and Psychiatry
at UCSF and lead author of this study. The prototype technology was
originally published as the cover story in Nature, showing
neurological changes and cognitive improvements in healthy older
adults (Anguera et al., 2013; Nature).
The trial, which was conducted in two phases, initially assessed
cognitive, behavioural, and neurological measurements of 62
children to quantify attentional abilities and the neurological
underpinnings of these abilities. This study included a subset of
children with SPD (roughly 54% of the sample) who were also
stratified by an inattention/hyperactivity based on the Vanderbilt
Assessment. The study found that children with SPD and
inattention/hyperactivity performed worse at baseline on measures
of cognition as well as the neurological measure (midline frontal
theta power), compared to typically developing children and the SPD
children who did not meet the inattention criteria.
"We're encouraged to see not only the magnitude and duration of
what appears to be a meaningful treatment effect, but also
continued validation of the targeted neurological mechanism of our
technology," said Eddie Martucci Ph.D., Chief Executive Officer of
Akili. "We are currently in the midst of a large-scale, randomized,
controlled trial in ADHD, and we are excited to continue our
clinical research to validate our digital treatments in populations
where we can have a meaningful impact."
"Once again, we are reminded by this study that it is critical
to assess specific domains of function in our children with
neurodevelopmental differences, in this case attention/cognitive
control," said Elysa Marco, MD, Associate Professor in the
Departments of Neurology, Psychiatry, and Pediatrics at UCSF and an
author on the study. "Once an area of challenge is identified,
specifically targeting that skill or challenge can make a
difference not only in brain activity but also in the
classroom."
Akili's Project: EVO(TM) is currently being evaluated in a
large, multi-site, randomised controlled trial in patients with
paediatric ADHD that may serve the basis of the company's
submission to the FDA for clearance as a medical device treatment
for the paediatric disorder. The company is developing other
treatment and screening products that are based on the same
technology that targets cognitive control to address a significant
unmet need in various patient populations with cognitive
deficiencies.
Akili and the investigators of the trial are conducting ongoing
work to further study attention characterisation and treatment and
paediatric cognitive disorders.
About Akili's Products
Akili's technologies are based on a proprietary neuroscience
approach developed to target specific neurological systems through
sensory and digital mechanics. The company's lead, patent-pending
technology platform (used in this trial) is based on cognitive
science exclusively licensed from the lab of Dr. Adam Gazzaley at
the University of California, San Francisco, and proprietary
adaptive algorithms developed at Akili, all built into action video
game interfaces. The platform powers both assessment and treatment
products, which deploy real-time, adaptive cognitive challenges and
interventions, respectively. Both products target the brain's
interference processing system (an individual's core ability to
process multiple streams of information), a key function underlying
cognitive control.
Akili is currently conducting multiple clinical trials of its
leading digital medicine platform across a variety of patient
populations, including paediatric ADHD, autism spectrum disorder
(in collaboration with Autism Speaks), depression, Alzheimer's
disease and traumatic brain injury.
About Akili Interactive Labs, Inc.
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 medical
product that can offer safe and effective scalable treatment and
better monitoring for patients across a range of mental health and
neurological conditions. The company was founded by and is a
subsidiary of PureTech Health (PRTC.L), together with leading
neuroscientists and game designers. Akili's lead product candidate,
Project: EVO(TM) , is currently being evaluated in a pivotal trial
in patients with paediatric ADHD that may serve the basis of the
company's submission to the FDA for clearance as a medical device
treatment for the paediatric disorder. Akili has garnered
investment from Shire PLC, Amgen Ventures and Merck Ventures BV,
Amsterdam, The Netherlands, a subsidiary of Merck KGaA, Darmstadt,
Germany (known as M Ventures in the United States and Canada), and
it has strategic partnerships with Pfizer Inc. and Autism
Speaks.
PureTech Health plc (PRTC.L) owns 56.5% of the company as of 31
December 2016. This is calculated on a diluted basis, including
issued and outstanding shares, options outstanding warrants, , as
well as written commitments to issue options, but excluding
unallocated shares authorised to be issued pursuant to equity
incentive plans.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is a
cross-disciplinary, advanced, clinical-stage biopharmaceutical
company developing novel medicines that modulate the adaptive human
systems. PureTech's therapies target the dysfunctions in the
immune, nervous, and gastro-intestinal systems by addressing the
underlying pathophysiology of disease from a systems perspective
rather than through a single receptor or pathway. The company is
advancing a rich pipeline that includes multiple human
proof-of-concept studies and pivotal or registration studies
expected to read out over the next 12 to 18 months. PureTech
Health's growing research and development pipeline has been
developed in collaboration with some of the world's leading
scientific experts, who along with PureTech's experienced team and
a stellar board identify, analyse and advance very selectively the
opportunities the company believes hold the most promise for
patients. This experienced and engaged team places PureTech Health
at the forefront of ground-breaking science and technological
innovation and leads the company between and beyond existing
disciplines. 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.
For further information:
PureTech Health FTI Consulting
Allison Mead Ben Atwell, Matthew
+1 617 651 3156 Cole
amead@puretechhealth.com +44 (0) 20 3727
1000
This information is provided by RNS
The company news service from the London Stock Exchange
END
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