TIDMPRTC
PureTech Health PLC
07 April 2021
7 April 2021
PureTech Health plc
PureTech Founded Entity Akili Collaborates with Weill Cornell
Medicine, NewYork-Presbyterian Hospital and Vanderbilt University
Medical Center to Study Digital Therapeutic AKL-T01 as Potential
Treatment for Patients with COVID Brain Fog
AKL-T01 is the first and only digital therapeutic specifically
designed to improve attention function
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating
diseases , is pleased to note that its Founded Entity, Akili Interactive (Akili) today announced collaborations with Weill Cornell Medicine , NewYork-Presbyterian Hospital and Vanderbilt University Medical Center to evaluate Akili digital therapeutic AKL-T01 as a treatment for patients with cognitive dysfunction following COVID-19 (also known as "COVID brain fog"). There are currently no approved treatments for cognitive impairments in COVID-19 survivors.
Under each collaboration, Akili will work with research teams at
each institution to conduct two separate randomized, controlled
clinical studies evaluating AKL-T01's ability to target and improve
cognitive functioning in COVID-19 survivors who have exhibited a
deficit in cognition. AKL-T01 is the first and only digital
therapeutic specifically designed to improve attention function.
The organizations aim to begin clinical recruitment for the studies
in the next month.
Since being named a global pandemic by the World Health
Organization in March 2020, clinicians continue to learn about the
vast ways in which COVID-19 manifests in patients. Evidence is
mounting on long-term neurological and cognitive symptoms that can
persist in some COVID-19 patients after initial diagnosis, even
after the virus is no longer detected in the body. A study
published in Neuropsychopharmacology led by Drs. Abhishek Jaywant
and Faith Gunning at Weill Cornell Medicine and
NewYork-Presbyterian found that difficulties in attention,
multitasking, and processing speed were common in hospitalized
patients recovering from COVID-19(1) . Of the patients in their
study, 81% exhibited some degree of cognitive impairment(1) .
Recent research also shows these cognitive impairments may persist
post-hospitalization and commonly occur in "post-COVID long
haulers" or "long COVID" patients. These impairments can have a
significant impact on survivors' daily functioning and quality of
life, impacting the ability of most COVID-19 long haulers to work
for six months or more according to a recent study(2) . For more
information on COVID brain fog, click here .
The full text of the announcement from Akili is as follows:
Akili Collaborates with Weill Cornell Medicine,
NewYork-Presbyterian Hospital and Vanderbilt University Medical
Center to Study Digital Therapeutic AKL-T01 as Treatment for
Patients with COVID Brain Fog
AKL-T01 is the first and only digital therapeutic specifically
designed to improve attention function
BOSTON - April 7, 2021 - Akili Interactive ("Akili" or
"Company"), today announced collaborations with Weill Cornell
Medicine , NewYork-Presbyterian Hospital and Vanderbilt University
Medical Center to evaluate Akili digital therapeutic AKL-T01 as a
treatment for patients with cognitive dysfunction following
COVID-19 (also known as "COVID brain fog"). There are currently no
approved treatments for cognitive impairments in COVID-19
survivors.
Under each collaboration, Akili will work with research teams at
each institution to conduct two separate randomized, controlled
clinical studies evaluating AKL-T01's ability to target and improve
cognitive functioning in COVID-19 survivors who have exhibited a
deficit in cognition. AKL-T01 is the first and only digital
therapeutic specifically designed to improve attention function.
The organizations aim to begin clinical recruitment for the studies
in the next month.
"As frontline healthcare workers continue to fight the immediate
acute symptoms of COVID-19, certain longer-term consequences of the
illness are beginning to emerge, including serious cognitive
impairments," said Anil S. Jina, M.D., Chief Medical Officer at
Akili. "With more than 100 million infections globally and
counting, the potential impact of long-term cognitive impairments
in even a subset of these patients is devastating. We look forward
to working with leading researchers at Vanderbilt, Weill Cornell
and NewYork-Presbyterian to understand and improve COVID-19-related
cognitive deficits."
Since being named a global pandemic by the World Health
Organization in March 2020, clinicians continue to learn about the
vast ways in which COVID-19 manifests in patients. Evidence is
mounting on long-term neurological and cognitive symptoms that can
persist in some COVID-19 patients after initial diagnosis, even
after the virus is no longer detected in the body. A study
published in Neuropsychopharmacology led by Drs. Abhishek Jaywant
and Faith Gunning at Weill Cornell Medicine and
NewYork-Presbyterian found that difficulties in attention,
multitasking, and processing speed were common in hospitalized
patients recovering from COVID-19(1) . Of the patients in their
study, 81% exhibited some degree of cognitive impairment(1) .
Recent research also shows these cognitive impairments may persist
post-hospitalization and commonly occur in "post-COVID long
haulers" or "long COVID" patients. These impairments can have a
significant impact on survivors' daily functioning and quality of
life, impacting the ability of most COVID-19 long haulers to work
for six months or more according to a recent study(2) . For more
information on COVID brain fog, click here .
"Clinicians are seeing an increase in cognitive impairments
among COVID-19 patients and though we don't yet know how long these
difficulties last, we are concerned about how these cognitive
difficulties may affect people in their daily lives," said Gunning
Ph.D., Vice Chair of Research in the Department of Psychiatry,
associate professor of psychology in psychiatry at Weill Cornell
Medicine, and associate attending psychologist at
NewYork-Presbyterian/Weill Cornell Medical Center, who is the study
coordinator. "It's critical that we identify therapeutics to help
the increasing number of people whose lives have been impacted by
cognitive impairments associated with COVID-19."
"The chronic symptoms of COVID-19 long haulers represent a
serious and growing public health concern that will linger long
after the acute nature of COVID-19 has passed," said James Jackson,
PsyD, Assistant Director of The ICU Recovery Center at Vanderbilt
and lead psychologist for the Critical Illness, Brain Dysfunction
and Survivorship (CIBS) Center at the Vanderbilt University Medical
Center . "We're excited by the potential of new therapeutics that
target cognitive impairments to help COVID-19 survivors."
AKL-T01 is built on the Akili Selective Stimulus Management
Engine (SSME(TM) ), a disease agnostic proprietary technology
designed to treat impaired cognitive function, specifically
attention control. Delivered through an action video game
experience, the first-in-class technology 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 personalize the
treatment experience for each individual patient. SSME has been
evaluated as a potential treatment for cognitive impairments
associated with a number of different disease areas and has been
studied in more than 2600 patients across 30 clinical trials.
AKL-T01, branded EndeavorRx (TM) , is cleared for use by the U.S.
Food and Drug Administration (FDA)(3) and has received Conformité
Européenne (CE) Mark certification in Europe for use in pediatric
ADHD(4) . Product screenshots and b-roll are available here .
Study Designs
The Akili, Weill Cornell Medicine and NewYork-Presbyterian
Hospital randomized, controlled study will evaluate AKL-T01 in
approximately 100 COVID-19 survivors ages 18-89 who have exhibited
a deficit in cognition. The study will take place over 10 weeks,
with 6 weeks of treatment and 4 weeks of follow-up. Half of the
study participants will receive the digital treatment and half will
serve as a control group. The primary endpoint of the study is mean
change in cognitive function, as assessed by a measure of attention
and processing speed. Secondary endpoints include additional
measures of cognitive functioning. The study will be conducted
remotely in patients' homes, and patients in the control arm will
have the option to receive the AKL-T01 intervention after the
conclusion of their participation in the control condition.
The Akili and Vanderbilt randomized, controlled study will
evaluate AKL-T01 in approximately 100 COVID-19 survivors ages 18
and older who have exhibited a deficit in cognition. The study will
recruit from subjects who have completed the SARS-CoV-2 Household
Transmission Study. Half of the study participants will receive the
digital treatment for 4 weeks and half will serve as a control
group. The primary endpoint of the study is mean change in
cognitive function, as measured by CNS Vital Signs (composite score
of cognitive function, especially attention and processing speed).
Secondary endpoints include additional measures of cognitive
functioning. The study will be conducted remotely in patients'
homes.
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 has pioneered the development of
video game-based digital medicine to improve cognitive function.
Akili's flagship product 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
.
_____________________________________________________________________________________
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing 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,
as of the date of PureTech's most recently filed Registration
Statement on Form 20-F, was comprised of 24 therapeutics and
therapeutic candidates, including two that have received FDA
clearance and European marketing authorization. All of the
underlying programs 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.
Cautionary Note Regarding Forward-Looking Statements
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, our expectations regarding the potential therapeutic benefits
of Akili's AKL-T01 as a treatment for patients with cognitive
dysfunction following COVID-19 , and 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
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
(1) Jaywant et al. Neuropsychopharmacol . (2021).
(2) David et al. Preprint . (2020).
(3) EndeavorRx is an FDA-cleared medical device. It is indicated
to improve attention function as measured by computer-based testing
in children ages 8-12 years old with primarily inattentive or
combined-type ADHD, who have a demonstrated attention issue.
Patients who engage with EndeavorRx demonstrate improvements in a
digitally assessed measure Test of Variables of Attention (TOVA) of
sustained and selective attention and may not display benefits in
typical behavioral symptoms, such as hyperactivity. EndeavorRx
should be considered for use as part of a therapeutic program that
may include clinician-directed therapy, medication, and/or
educational programs, which further address symptoms of the
disorder. EndeavorRx is available by prescription only. It is not
intended to be used as a stand-alone therapeutic and is not a
substitution for a child's medication.
(4) In June, 2020, EndeavorRx received Conformité Européenne
(CE) Mark certification as a prescription-only digital therapeutic
software intended for the treatment of attention and inhibitory
control deficits in pediatric patients with ADHD.
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