TIDMPRTC
PureTech Health PLC
17 February 2022
17 February 2022
PureTech Health plc
PureTech Founded Entity Akili Announces PLOS ONE Publication of
Clinical Study Results and EEG Data Showing Akili Digital
Therapeutic EndeavorRx (R) 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
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 (R) 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(R)) 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 (R) 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.
Contact:
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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