TIDMPRTC
RNS Number : 2260Y
PureTech Health PLC
04 December 2017
4 December 2017
PureTech Health plc
PureTech's Akili Achieves Primary Endpoint in Pivotal Study of
Investigational Digital Medicine for Paediatric ADHD
This successful outcome builds on recent clinical achievements
and value created at PureTech Health
PureTech Health plc ("PureTech", LSE: PRTC), an advanced,
clinical-stage biopharmaceutical company, is pleased to note that
Akili Interactive Labs, Inc., an affiliate of PureTech Health,
today announced positive results from its pivotal study in
paediatric attention-deficit/hyperactivity disorder (ADHD).
AKL-T01, the lead investigational digital medicine from the
Project:EVO(TM) platform, successfully showed a statistically
significant improvement compared to an active control (p = 0.006)
on the predefined primary endpoint, a composite score from the Test
of Variables of Attention (T.O.V.A.(R)), an objective measure of
sustained attention and inhibitory control.
Daphne Zohar, Co-founder and Chief Executive Officer of PureTech
Health, said: "This exciting result in paediatric ADHD is a
significant validation of Akili's technology. For PureTech Health
it represents a third valuable milestone in our clinically
validated programmes in recent months, in addition to the
advancement of the resTORbio Phase 2b programme and positive
results from the pivotal Gelesis100 weight loss study. Each of
these clinical milestones advances our mission to improve and
extend the lives of patients through the development of new
categories of medicine and to lay the foundation for driving
significant shareholder value."
Based on these results and the results of the previously
announced pivotal Gelesis100 weight loss study, PureTech Health
anticipates two regulatory filings with the U.S. Food and Drug
Administration in the first half of 2018.
The full text of the announcement from Akili is as follows:
Akili Achieves Primary Efficacy Endpoint in Paediatric ADHD
Pivotal Trial
Company Completes Large Multi-Centre, Randomised, Controlled
Study of Novel Digital Medicine and Plans Regulatory Filing
BOSTON, Mass - December 4, 2017 - Akili Interactive ("Akili" or
"Company"), an affiliate of PureTech Health (PRTC.L), today
announced top-line results from the Company's STARS-ADHD pivotal
study of its lead investigational digital medicine, AKL-T01, in
paediatric attention-deficit/hyperactivity disorder (ADHD). In a
randomised, controlled trial of 348 children and adolescents
diagnosed with ADHD, AKL-T01 showed a statistically significant
improvement compared to an active control (p=0.006) on the
predefined primary endpoint, a change in the Attention Performance
Index (API), a composite score from the Test of Variables of
Attention (T.O.V.A.(R)). The T.O.V.A.(R) is an objective measure of
sustained attention and inhibitory control. AKL-T01 was shown to be
safe in this study, with no serious adverse events observed.
Subjective secondary outcome measures showed statistically
significant positive improvements in both the treatment and active
control groups, though there was not a statistically significant
separation on those measures between groups. Full analysis is
underway and results of the study will be presented at an upcoming
scientific conference and will be submitted for publication in a
peer-reviewed journal. Based on the results of the study, Akili
plans to file AKL-T01 with the U.S. Food and Drug Administration
(FDA) for clearance as a novel treatment for children and
adolescents with ADHD.
"This innovative study represents, to my knowledge, the largest
and most rigorous evaluation of a digital medicine," said Dr. Scott
Kollins, Professor of Psychiatry, Director of the ADHD Program at
Duke University School of Medicine and principal investigator for
the study. "The objective improvements of attention observed in the
study suggest that AKL-T01 addresses a key deficiency in ADHD that
is not directly targeted by standard treatments. Since the active
control group in this study also played an engaging video game, we
are encouraged that the statistically significant group differences
were driven by the therapeutically active component in AKL-T01 and
not just the video game experience."
ADHD is a neurodevelopmental disorder affecting approximately 11
percent of school-age children and is characterised by
developmentally inappropriate cognitive function, with symptoms
including inattention, impulsivity and hyperactivity.
Pharmaceuticals are the standard of care for the treatment of
paediatric ADHD. However, many children are inadequately managed on
medication, including tolerability concerns, and additionally a
significant number of parents choose not to treat their children
with traditional pharmaceuticals.
"For children with ADHD, inattention can cause many challenges
both at school and at home. A treatment that can reduce a child
with ADHD's inattention holds the promise of improving their
lives," said Dr. Robert L. Findling, Vice President, Psychiatry
Services and Research, Kennedy Krieger Institute; Director, Child
and Adolescent Psychiatry, Johns Hopkins University.
In the 20-site multi-centre, randomised controlled trial, the
348 children and adolescents with ADHD and objective attention
deficits were evaluated before and after four weeks of at-home
treatment with either AKL-T01 or an active control which was
designed and tested to have a similar level of expectation of
benefits and engagement. Children and adolescents receiving AKL-T01
showed a statistically significant improvement in attentional
functioning on the Attention Performance Index (API), a composite,
objective measurement of attention and the pre-defined primary
endpoint of the study, compared to no improvement in the active
control group (p = 0.006). AKL-T01 was safe and well-tolerated with
only 11 treatment-related adverse events reported, primarily
headache and frustration. No serious adverse events were reported
and only one patient discontinued treatment. Both the treatment and
active control group showed statistically significant improvement
from baseline on a range of subjective behavioural secondary
outcome measures. Differences between the groups on the secondary
outcomes were not statistically significant. Full analysis of
pre-specified secondary and exploratory outcomes is underway and
the data will be presented in upcoming peer-reviewed publications
and medical meetings.
"This is an exciting milestone for our company, for the digital
therapeutic community, and for families and children affected by
ADHD. We look forward to advancing AKL-T01 through our planned
regulatory process and toward the market," said Eddie Martucci,
Ph.D., Akili's President and CEO. "The study results further
validate Akili's technology platform as we continue to advance our
pipeline of digital treatments targeting cognitive dysfunction in
ADHD and other patient populations, and work toward our vision of
re-defining medicine."
About AKL-T01
AKL-T01, Akili's ADHD treatment in development, is a
first-of-its-kind prescription digital medicine being evaluated as
a potential treatment for ADHD. Engineered as a therapeutically
active treatment for cognitive deficiency in paediatric patients
affected by ADHD, AKL-T01 is built on Akili's proprietary, patented
Project: EVO(TM) technology platform that enables selective
targeting and activation of specific cognitive neural systems in
the brain that exhibit deficiencies from various medical
conditions. AKL-T01 uses adaptive algorithms to deliver the
presentation of stimuli that engage targeted neural systems in the
prefrontal cortex, the front part of the brain known to play a key
role in cognitive control and known to be deficient in ADHD. In a
closed-loop system, the adaptive algorithms automatically adjust
the level - or dose - for a personalised treatment experience that
is tailored to the needs of each individual patient. Rather than
being administered through a pill, AKL-T01 is delivered through a
creative and immersive action video game experience. The treatment
looks and feels like a high-end video game, leveraging art, music,
storytelling, and reward cycles to keep patients engaged and
immersed for the delivery of therapeutic activity with excellent
compliance. The science behind AKL-T01 was developed at the
University of California, San Francisco by Adam Gazzaley, M.D.,
Ph.D., Founding Director of the University of California San
Francisco's Neuroscape and Akili's Chief Science Advisor.
About STARS-ADHD Trial
The STARS-ADHD pivotal study of AKL-T01 was a multi-centre,
randomised, double-blind, active-controlled study in 348 children
ages 8-12 diagnosed with ADHD. Patients were randomised 1:1 to
AKL-T01 or an active control. Both groups used the
treatment/control at home on a tablet device for four weeks. The
active control application was deployed in the same format as
AKL-T01, a mobile tablet, and mimicked the reward and engagement of
AKL-T01 but deployed different stimuli than the
therapeutically-active component. After the four-week period, an
in-clinic assessment measured changes from baseline on standard
measures of attention, memory and impulsivity. The primary endpoint
of the study was change in the Attention Performance Index (API), a
composite score from the Test of Variables of Attention
(T.O.V.A.(R)), an FDA-cleared continuous performance test measuring
sustained attention and inhibitory control. Secondary outcomes
included subjective parent-reported behavioural ratings. The study
was managed by the Duke Clinical Research Institute.
About T.O.V.A.(R)
The Test of Variables of Attention (T.O.V.A.(R)) is an
objective, accurate, and FDA-cleared continuous performance test
(CPT) that measures the key components of attention and inhibitory
control. The T.O.V.A.(R) is used by qualified healthcare
professionals as an aid in the assessment of attention deficits,
including attention-deficit/hyperactivity disorder (ADHD), in
children and adults. The T.O.V.A.(R) calculates response time
variability (consistency), response time (speed), commissions
(impulsivity), and omissions (focus and vigilance). These
calculations are then compared to a large age- and gender-matched
normative sample, as well as to a sample population of individuals
independently diagnosed with ADHD. The T.O.V.A.(R) provides
information that is not available through self-report or the report
of others. It is used along with a clinical interview and
subjective measures (such as behaviour ratings) for a more
comprehensive picture of academic, social, and personal performance
and impairment.
About Akili
Akili Interactive Labs, Inc. is a prescription digital medicine
company combining scientific and clinical rigour with the ingenuity
of the tech industry to reinvent medicine. Akili is pioneering the
development of digital treatments with direct therapeutic activity,
delivered not through a pill but through a high-quality action
video game experience. Akili is advancing a broad pipeline of
programmes to treat cognitive deficiency and improve symptoms
associated with medical conditions across neurology and psychiatry,
including attention-deficit hyperactivity/ disorder (ADHD), major
depressive disorder (MDD), autism spectrum disorder (ASD) and
multiple sclerosis (MS) and various inflammatory diseases. Akili is
also developing complementary and integrated clinical monitors and
measurement-based care applications. The company was founded by and
is an affiliate of PureTech Health (PRTC.L). For more information
visit: www.akiliinteractive.com.
Akili is a founding member of the Digital Therapeutics
Alliance.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is an advanced,
clinical-stage biopharmaceutical company developing novel medicines
targeting serious diseases that result from dysfunctions in the
nervous, immune, and gastrointestinal systems (brain-immune-gut or
the "BIG" axis), which together represent the adaptive human
systems. PureTech Health is at the forefront of understanding and
addressing the biological processes and crosstalk associated with
the BIG axis. By harnessing this emerging field of human biology,
the Company is pioneering new categories of medicine with the
potential to have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies that includes two pivotal stage programmes, multiple
human proof-of-concept studies and a number of early clinical and
pre-clinical programmes. PureTech's rich research and development
pipeline has been advanced in collaboration with some of the
world's leading scientific experts, who along with PureTech's team
of biopharma pioneers, entrepreneurs and seasoned Board, identify,
invent, and clinically de-risk new medicines. With this experienced
team pursuing cutting edge science, PureTech Health is building the
biopharma company of the future focused on improving and extending
the lives of people with serious disease. 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
PureTech'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. 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 PureTech Health 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:
PureTech Health FTI Consulting
Allison Mead Talbot Ben Atwell, Rob
+1 617 651 3156 Winder
amt@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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