TIDMPRTC
PureTech Health PLC
11 December 2019
12 December 2019
PureTech Health plc
PureTech Affiliate Akili Announces AKL-T03 Achieved Primary
Endpoint, Improving Cognitive Impairments in Major Depressive
Disorder Trial
Data Presented at the 58(th) Annual Meeting of the American
College of Neuropsychopharmacology
PureTech Health plc (LSE: PRTC) ("PureTech"), a clinical stage
biotechnology company dedicated to discovering, developing and
commercialising highly-differentiated medicines for devastating
diseases, is pleased to note that its affiliate, Akili, today
announced the results of its randomised, controlled trial of
digital therapeutic AKL-T03 as a treatment for cognitive
impairments adjunct to anti-depressant medication in adults with
Major Depressive Disorder (MDD). In the study, AKL-T03 demonstrated
a statistically significant improvement in sustained attention
compared to control. AKL-T03 is designed to improve specific
cognitive functions and may play a complementary role to
antidepressants in the holistic treatment of MDD. Results of the
study were presented yesterday at the 58(th) Annual Meeting of the
American College of Neuropsychopharmacology.
Eric Elenko, PhD, chief innovation officer at PureTech, said:
"We are pleased with these results as they provide additional
support for the potential of Akili's proprietary digital treatment
platform across multiple indications."
The full text of the announcement from Akili is as follows:
Akili Technology Improves Cognitive Impairments in Adults with
Major Depressive Disorder
Primary Endpoint Achieved in Randomised, Controlled Trial of
Digital Therapeutic AKL-T03 in Major Depressive Disorder (MDD)
Data Presented at the 58(th) Annual Meeting of the American
College of Neuropsychopharmacology
BOSTON, December 12, 2019 - Akili Interactive ("Akili" or
"Company"), today announced results of its randomised, controlled
study of digital therapeutic AKL-T03 as a treatment for cognitive
impairments adjunct to anti-depressant medication in adults with
MDD. AKL-T03 demonstrated a statistically significant improvement
in sustained attention compared to control. Results of the study
were presented yesterday at the 58(th) Annual Meeting of the
American College of Neuropsychopharmacology (ACNP).
Cognitive impairment is a fundamental diagnostic criterion of
depression, and the majority of people living with MDD experience
substantial cognitive issues, including with attention,
decision-making and processing speed. Such cognitive impairments
have been shown to be a predictor of daily function. More than 16
million people are living with MDD, and a majority have cognitive
deficits on neuropsychological tests and/or self-report cognitive
issues, yet their options for treatment are limited.
"The majority of patients with MDD experience cognitive
impairments, significantly impacting their day-to-day function and
quality of life as well as in their risk of recurrence of
depression. These impairments are as important to treat as the
classical depressive symptoms and, for many patients, persist even
after successful antidepressant treatment," said Richard Keefe,
PhD, Professor of Psychiatry at Duke University Medical Center and
primary investigator of the study. "Based on the results of this
study, when combined with antidepressants, AKL-T03 potentially
represents a low-risk treatment option that appears to improve
cognitive impairments in MDD where few options are available for
patients today."
AKL-T03 is designed to improve specific cognitive functions and
may play a complementary role to antidepressants in the holistic
treatment of MDD. AKL-T03 was built on Akili's SSME technology
engine, which deploys sensory and motor stimuli to target and
activate the fronto-parietal network in the brain, known to play a
key role in cognitive function. The treatment is delivered through
a captivating action video game to drive enjoyment and
compliance.
"We believe cognitive issues represent one of the major unmet
medical needs of the next decade and have a debilitating effect on
the lives of millions of people, both with and without medical
diagnoses," said Eddie Martucci, CEO of Akili Interactive. "We're
very encouraged by the results of our study of AKL-T03, which add
to our growing body of data on our SSME technology engine's ability
to improve cognitive impairments across a number of populations in
need."
In the study, AKL-T03 showed a statistically significant
improvement in sustained attention compared to control (p=0.002) on
the predefined primary endpoint, as measured by the Test of
Variables of Attention (T.O.V.A.(R)), an FDA-cleared objective
measure of attention. Engagement with AKL-T03 also showed a strong
correlation with improved processing speed. AKL-T03 was shown to be
safe in this study, with no serious adverse events observed.
Results of the study will be submitted for publication in a
peer-reviewed journal.
For Patients
In this study, the potential digital treatment, AKL-T03, was
compared to a non-therapeutic product (the control) to evaluate
AKL-T03's safety and ability to improve certain cognitive
impairments and, specifically, sustained attention, which is
ability to focus on an activity over a long period of time. The
study showed that AKL-T03 significantly improved patients'
sustained attention as compared to the control which did not show
an improvement. Engagement with AKL-T03 was also shown to be
associated with improved processing speed, or the time required to
complete a specific task. At this time, AKL-T03 is not yet
available for patient use outside of clinical studies. For more
information on Akili's clinical studies, please visit
www.clinicaltrials.org and talk with your doctor.
Study Design
The study was a multi-centre, randomised, controlled trial of
AKL-T03 in over 80 adult participants diagnosed with
mild-to-moderate MDD symptoms and with mild-to-moderate cognitive
impairment. All participants were on stable antidepressant
medication. Participants were randomised 1:1 to AKL-T03 (video
game-based digital therapeutic) or a control (video game designed
with similar reward and engagement of AKL-T03). Both groups used
the treatment/control at home, 5 days per week for 25 minutes per
day, on a tablet device for six weeks. Following the treatment
period, an in-clinic assessment was conducted to assess key
outcomes. The primary outcome of the study assessed sustained
attention as measured by Test of Variables of Attention
(T.O.V.A.(R)). The study was managed by VeraSci.
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 is pioneering the development of
digital treatments and care solutions to help people affected by
cognitive impairments. Akili's treatments directly activate the
networks in the brain responsible for cognitive function and have
been rigorously tested in extensive clinical studies, including
prospective randomised, controlled trials. 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. For more information, please visit
www.akiliinteractive.com.
About PureTech Health
PureTech is a clinical stage biotechnology 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 affiliates, is comprised of 24 product
candidates and one product that has 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 Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
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END
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