Electroencephalography data (EEG) demonstrate
enhancement of brain activity specific to attention function in
children 8-12 with ADHD following AKL-T01 (EndeavorRx)
treatment
Data show correlation between targeted activity
in the brain and objective improvements in attention
function
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company noted today
that its Founded Entity, Akili Interactive Labs, Inc. (“Akili”), a
leading digital medicine company pioneering the development of
cognitive treatments through game-changing technologies, announced
the publication of full data from a single arm, unblinded study
conducted by Dr. Elysa Marco at Cortica Healthcare and Drs. Joaquin
Anguera and Courtney Gallen at the University of California, San
Francisco. The study measured electroencephalography (EEG) data
alongside behavioral and clinical metrics of attention in children
with ADHD using AKL-T01 (EndeavorRx). Data from the study show that
EndeavorRx treatment resulted in increased brain activity related
to attention function, as measured by EEG, which correlated with
improvements in objective behavioral measures of attention.
In this study, attention in children with ADHD was evaluated
using a well-established EEG-based measure of attentional control,
midline frontal theta (MFT) activity. Data show that EndeavorRx
enhanced MFT activity, suggesting that patients who used EndeavorRx
for 4 weeks showed changes in measurable brain function. Study
results also demonstrated a correlation between MFT activity and
attention functioning, suggesting that children who experienced the
largest gains in MFT activity as measured by EEG also showed the
greatest improvements in computerized performance tests designed to
measure attention. Additionally, parents reported significantly
fewer inattention symptoms in children treated with EndeavorRx, as
measured by the Vanderbilt ADHD Diagnostic Rating Scale.
The study results were published in the medical journal PLOS
ONE.
The full text of the announcement from Akili is as follows:
PLOS ONE Publishes Clinical Study Results
and EEG Data Showing Akili Digital Therapeutic EndeavorRx®
Activates Systems in Brain Key to Attentional Functioning
Electroencephalography data (EEG) demonstrate
enhancement of brain activity specific to attention function in
children 8-12 with ADHD following AKL-T01 (EndeavorRx)
treatment
Data show correlation between targeted activity
in the brain and objective improvements in attention function
BOSTON, Mass – February 17, 2022 – Akili Interactive
Labs, Inc. (“Akili”), a leading digital medicine company pioneering
the development of cognitive treatments through game-changing
technologies, today announced the publication of full data from a
single arm, unblinded study conducted by Dr. Elysa Marco at Cortica
Healthcare and Drs. Joaquin Anguera and Courtney Gallen at the
University of California, San Francisco. The study measured
electroencephalography (EEG) data alongside behavioral and clinical
metrics of attention in children with ADHD using AKL-T01
(EndeavorRx). Data from the study show that EndeavorRx treatment
resulted in increased brain activity related to attention function,
as measured by EEG, which correlated with improvements in objective
behavioral measures of attention. The study results were published
in the medical journal PLOS ONE.
In this study, attention in children with ADHD was evaluated
using a well-established EEG-based measure of attentional control,
midline frontal theta (MFT) activity. Data show that EndeavorRx
enhanced MFT activity, suggesting that patients who used EndeavorRx
for 4 weeks showed changes in measurable brain function. Study
results also demonstrated a correlation between MFT activity and
attention functioning, suggesting that children who experienced the
largest gains in MFT activity as measured by EEG also showed the
greatest improvements in computerized performance tests designed to
measure attention. Additionally, parents reported significantly
fewer inattention symptoms in children treated with EndeavorRx, as
measured by the Vanderbilt ADHD Diagnostic Rating Scale.
“While the previous multicenter trials have demonstrated
attention improvement for children using EndeavorRx, this is the
first study to look at the brain activity in children with a
primary concern of ADHD. It is exciting to see measurable
improvement on the EEGs that correlates with the behavioral
benefits,” said Elysa Marco, M.D., Principal Investigator of the
study, and Clinical Executive for Neurodevelopmental Medicine at
Cortica Healthcare.
“EndeavorRx was designed to target and activate attention
networks in the brain with the aim of driving clinically meaningful
cognitive changes in patients,” said Anil S. Jina M.D., Chief
Medical Officer of Akili. “What’s especially exciting about this
data is that, for the first time, we can see how the neural systems
of a child with ADHD are impacted with EndeavorRx treatment. We
look forward to continuing to learn about how the digital
therapeutic can help children with ADHD in their daily lives.”
EndeavorRx is the first-and-only FDA-cleared treatment delivered
through a video game experience. In the U.S., EndeavorRx 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. The
most common side effect observed in children in EndeavorRx’s
clinical trial was a feeling of frustration, as the game can be
quite challenging at times. No serious adverse events were
associated with its use. EndeavorRx is recommended to be used for
approximately 25 minutes a day, 5 days a week, over initially at
least 4 consecutive weeks, or as recommended by your child’s health
care provider. The U.S. commercial launch of EndeavorRx is planned
for the second half of 2022.
EndeavorRx has been rigorously evaluated across five clinical
studies in more than 600 children diagnosed with ADHD, including
STARS-ADHD, a prospective, randomized, controlled study published
in The Lancet Digital Health. This is the first study to use EEG
data to illustrate how EndeavorRx impacts activity in the brain for
children with ADHD. In addition to FDA clearance, the digital
therapeutic has received Conformité Européenne (CE) Mark
certification in Europe for use in pediatric ADHD. The
disease-agnostic proprietary technology underlying EndeavorRx is
also being studied by Akili in multiple other medical conditions
with associated chronic and acute cognitive impairments, including
autism spectrum disorder, multiple sclerosis, major depressive
disorder, COVID-19 brain fog, cancer-related cognitive impairment
and postoperative cognitive dysfunction.
Study Design This was a single arm, unblinded study of 25
children, 8-12 years old, with a confirmed diagnosis of ADHD. Study
participants were instructed to use EndeavorRx for approximately 25
minutes a day at least 5 days a week for 4 weeks. Assessments to
detect intervention-related changes were performed before (Day 0)
and after (Day 28) EndeavorRx treatment and included
stimulus-locked EEG to detect changes in neural signals, two
computerized tasks to index objective improvements in attentional
control, and a subjective questionnaire asking parents about their
children’s ADHD symptoms.
About Akili Akili is pioneering the development of
cognitive treatments through game-changing technologies. Our
approach of leveraging technologies designed to directly target the
brain establishes a new category of medicine – medicine that is
validated through clinical trials like a drug or medical device,
but experienced like entertainment. Akili’s platform is powered by
proprietary therapeutic engines designed to target cognitive
impairment at its source in the brain, informed by decades of
research and validated through rigorous clinical programs. Driven
by Akili’s belief that effective medicine can also be fun and
engaging, Akili’s products are delivered through captivating action
video game experiences.
On January 26, 2022, Akili entered into a definitive agreement
to become publicly traded via a merger with Social Capital Suvretta
Holdings Corp. I (Nasdaq: DNAA), a special purpose acquisition
company. The transaction is expected to close in mid-2022, subject
to satisfaction of the closing conditions, after which Akili will
be listed on the Nasdaq stock market under the new ticker symbol
“AKLI.”
For more information, please visit www.akiliinteractive.com.
Additional Information and Where to Find It In connection
with the proposed business combination transaction between Social
Capital Suvretta Holdings Corp. I (“SCS”) and Akili, SCS filed a
registration statement on Form S-4 (as amended, the “Registration
Statement”) with the SEC on February 14, 2022, which includes a
preliminary prospectus and proxy statement of SCS, referred to as a
proxy statement/prospectus. The Registration Statement has not yet
become effective. When available, a final proxy
statement/prospectus will be sent to all SCS shareholders. SCS will
also file other documents regarding the proposed transaction with
the SEC. SHAREHOLDERS OF SCS ARE ADVISED TO READ THE REGISTRATION
STATEMENT, THE PROXY STATEMENT/PROSPECTUS AND ALL OTHER RELEVANT
DOCUMENTS FILED OR THAT WILL BE FILED WITH THE SEC IN CONNECTION
WITH THE PROPOSED TRANSACTION AS THEY BECOME AVAILABLE BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION. Shareholders will be able to
obtain free copies of the Registration Statement, the proxy
statement/prospectus and all other relevant documents filed or that
will be filed with the SEC by SCS (when available) through the
website maintained by the SEC at http://www.sec.gov.
The documents filed by SCS with the SEC also may be obtained
free of charge at SCS’s website at
https://socialcapitalsuvrettaholdings.com/dnaa or upon written
request to 2850 W. Horizon Ridge Parkway, Suite 200, Henderson, NV
89052.
Participants in the Solicitation SCS and Akili and their
respective directors and executive officers may be deemed to be
participants in the solicitation of proxies from SCS’s shareholders
in connection with the proposed transaction. A list of the names of
such directors and executive officers and information regarding
their interests in the proposed transaction between Akili and SCS
are contained in the proxy statement/prospectus. You may obtain
free copies of these documents as described in the preceding
paragraph.
No Offer or Solicitation This communication shall not
constitute a solicitation of a proxy, consent or authorization with
respect to any securities or in respect of the proposed
transaction. This communication shall not constitute an offer to
sell or the solicitation of an offer to buy any securities, nor
shall there be any sale of securities in any states or
jurisdictions in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of such state or jurisdiction. No offering of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act or an
exemption therefrom. This press release may be deemed to be
solicitation material in respect of the proposed transactions
contemplated by the proposed business combination between Akili and
SCS.
Forward-Looking Statements This communication may contain
certain forward-looking statements within the meaning of the
federal securities laws with respect to the proposed transaction
between Akili and SCS. These forward-looking statements generally
are identified by the words “believe,” “project,” “expect,”
“anticipate,” “estimate,” “intend,” “strategy,” “future,”
“opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,”
“will continue,” “will likely result,” and similar expressions.
Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
communication, including but not limited to: (i) the risk that the
proposed transaction may not be completed in a timely manner or at
all, which may adversely affect the price of SCS’s securities, (ii)
the risk that the proposed transaction may not be completed by
SCS’s business combination deadline and the potential failure to
obtain an extension of the business combination deadline if sought
by SCS, (iii) the failure to satisfy the conditions to the
consummation of the proposed transaction, including the adoption of
the Merger Agreement by the shareholders of SCS and the
satisfaction of the minimum cash condition, (iv) the lack of a
third party valuation in determining whether or not to pursue the
proposed transaction, (v) the inability to complete the PIPE
Investment, (vi) the occurrence of any event, change or other
circumstance that could give rise to the termination of the Merger
Agreement, (vii) the effect of the announcement or pendency of the
transaction on Akili’s business relationships, operating results,
and business generally, (viii) risks that the proposed transaction
disrupts current plans and operations of Akili or diverts
management’s attention from Akili’s ongoing business operations and
potential difficulties in Akili employee retention as a result of
the announcement and consummation of the proposed transaction, (ix)
the outcome of any legal proceedings that may be instituted against
Akili or against SCS related to the Merger Agreement or the
proposed transaction, (x) the ability to maintain the listing of
SCS’s securities on a national securities exchange, (xi) the price
of SCS’s securities may be volatile due to a variety of factors,
including changes in the competitive and highly regulated
industries in which SCS plans to operate or Akili operates,
variations in operating performance across competitors, changes in
laws and regulations affecting SCS’s or Akili’s business, and
changes in the combined capital structure, (xii) the ability to
implement business plans, forecasts, and other expectations after
the completion of the proposed transaction, and identify and
realize additional opportunities, (xiii) the ability of Akili to
successfully commercialize EndeavorRx® and continue to advance its
clinical development pipeline, (xiv) the ability to recognize the
anticipated benefits of the proposed transaction, which may be
affected by, among other things, competition, the ability of the
combined company to grow and manage growth profitably, maintain
relationships with customers and suppliers and retain its
management and key employees, (xv) the evolution of the markets in
which Akili competes, (xvi) the ability of Akili to defend its
intellectual property and satisfy regulatory requirements, (xvii)
the costs related to the proposed transaction, (xviii) the impact
of the COVID-19 pandemic on Akili’s business, (xix) Akili’s
expectations regarding its market opportunities and (xx) the risk
of downturns and a changing regulatory landscape in the highly
competitive industry in which Akili operates. The foregoing list of
factors is not exhaustive. You should carefully consider the
foregoing factors and the other risks and uncertainties described
in the “Risk Factors” section of SCS’s registration on Form S-1
(File Nos. 333-256723 and 333-257543), SCS’s quarterly report on
Form 10-Q for the quarter ended September 30, 2021 filed with the
SEC on November 15, 2021, the Registration Statement on Form S-4,
including those under “Risk Factors” therein, and other documents
filed by SCS from time to time with the SEC. These filings identify
and address other important risks and uncertainties that could
cause actual events and results to differ materially from those
contained in the forward-looking statements. Forward-looking
statements speak only as of the date they are made. Readers are
cautioned not to put undue reliance on forward-looking statements,
and Akili and SCS assume no obligation and do not intend to update
or revise these forward-looking statements, whether as a result of
new information, future events, or otherwise. Neither Akili nor SCS
gives any assurance that either Akili or SCS, or the combined
company, will achieve its expectations.
About PureTech Health PureTech is a clinical-stage
biotherapeutics company dedicated to discovering, developing and
commercializing highly differentiated medicines for devastating
diseases, including inflammatory, fibrotic and immunological
conditions, intractable cancers, lymphatic and gastrointestinal
diseases and neurological and neuropsychological disorders, 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, is comprised of 25
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization, as of the date of PureTech's most recently filed
Half Year Report and corresponding Form 6-K. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic 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 within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
without limitation those statements that relate to expectations
around EndeavorRx launch timing, expectations around the potential
physiological effects of EndeavorRx, the competitive environment in
which Akili operates, and Akili and PureTech’s future prospects,
development plans, and strategies. The forward-looking statements
are based on current expectations and are subject to known and
unknown risks, uncertainties and other important factors that could
cause actual results, performance and achievements to differ
materially from current expectations, including, but not limited
to, those risks, uncertainties and other important factors
described under the caption “Risk Factors” in our Annual Report on
Form 20-F for the year ended December 31, 2020 filed with the SEC
and in our other regulatory filings. 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, we disclaim any
obligation to update or revise these forward-looking statements,
whether as a result of new information, future events or
otherwise.
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PureTech Public Relations
publicrelations@puretechealth.com Investor Relations
IR@puretechhealth.com
EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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