RCS - PureTech Health PLC - Akili Depression Data Published in AJP

Puretech HealthAnnouncement

12/04/2022 12:15

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RNS Number : 0379I  PureTech Health PLC  12 April 2022

12 April 2022

PureTech Health plc

 

PureTech Founded Entity Akili Announces American Journal of Psychiatry
Publication of Data Demonstrating its Digital Therapeutic AKL-T03 Improves
Cognitive Impairments in Adults with Major Depressive Disorder When Combined
with Antidepressant Medication

 

AKL-T03 showed a statistically significant improvement in sustained attention
compared to control intervention

 

AKL-T03 is built on the same technology engine as Akili's digital therapeutic
EndeavorRx, which has been cleared by the U.S. Food and Drug Administration
(FDA) for use in children with ADHD (see full indication below)

 

PureTech Health plc (https://puretechhealth.com/) (Nasdaq: PRTC, LSE: PRTC)
("PureTech" or the "Company"), a clinical-stage biotherapeutics company noted
that its Founded Entity, Akili Interactive Labs, Inc. ("Akili"), a leading
cognitive medicine company improving health through game-changing
technologies, today announced that the American Journal of Psychiatry has
published (https://ajp.psychiatryonline.org/doi/abs/10.1176/appi.ajp.21020125)
findings from the STARS-MDD clinical trial evaluating Akili's AKL-T03 digital
therapeutic as a potential treatment for attention impairments in adults with
major depressive disorder (MDD) when used alongside antidepressant medication.

( )

More than 16 million people in the United States are living with MDD.(1)
Despite the positive benefits of antidepressant therapy on mood, most
pharmacologic treatments provide little or no benefit on cognitive impairments
in patients with MDD.(234) Many patients with MDD who have responded to
antidepressant treatment continue to report cognitive challenges, including
difficulties concentrating, decision making, slowed thinking, and
forgetfulness, which have been shown to have an impact on daily activities,
like education and work.(5)

 

The STARS-MDD study enrolled 80 adults, ages 25-55, who were stably treated
with an antidepressant medication yet were still experiencing mild to moderate
symptoms of depression as well as cognitive impairments. Patients were
randomized 1:1 to AKL-T03 or a digital control designed to have an equal
expectation of benefit. Results of the study demonstrated that the addition of
AKL-T03 to antidepressant therapy significantly improved sustained attention
in adults diagnosed with MDD compared to the control (p=0.005), as measured by
the Test of Variables of Attention (TOVA), which is a computerized test
cleared by FDA to assess attention deficits and evaluate the effects of
interventions in ADHD.

 

The full text of the announcement from Akili is as follows:

 

The American Journal of Psychiatry Publishes Data Demonstrating Akili
Interactive's Digital Therapeutic AKL-T03 Improves Cognitive Impairments in
Adults with Major Depressive Disorder When Combined with Antidepressant
Medication

 

AKL-T03 showed a statistically significant improvement in sustained attention
compared to control intervention

 

AKL-T03 is built on the same technology engine as Akili's digital therapeutic
EndeavorRx, which has been cleared by the U.S. Food and Drug Administration
(FDA) for use in children with ADHD (see full indication below)

 

BOSTON, Mass - April 12, 2022 - Akili Interactive ("Akili"), a leading
cognitive medicine company improving health through game-changing
technologies, today announced that the American Journal of Psychiatry
has published
(https://ajp.psychiatryonline.org/doi/abs/10.1176/appi.ajp.21020125)
 findings from the STARS-MDD clinical trial evaluating Akili's AKL-T03
digital therapeutic as a potential treatment for attention impairments in
adults with major depressive disorder (MDD) when used alongside antidepressant
medication.

 

More than 16 million people in the United States are living with MDD.(1)
Despite the positive benefits of antidepressant therapy on mood, most
pharmacologic treatments provide little or no benefit on cognitive impairments
in patients with MDD.(234) Many patients with MDD who have responded to
antidepressant treatment continue to report cognitive challenges, including
difficulties concentrating, decision making, slowed thinking, and
forgetfulness, which have been shown to have an impact on daily activities,
like education and work.(5)

 

"Society is facing a growing mental health crisis, with depression rates in
the U.S. increasing about 20% during the pandemic. While mood symptoms are
most often associated with MDD, equally concerning are the frequent associated
cognitive impairments," said Richard Keefe, Ph.D., Professor of Psychiatry at
Duke University Medical Center, and primary investigator of the study. "More
than ever, we need safe and effective ways to support these patients - new
tools that can be easily and broadly accessed. Based on the results of this
study, AKL-T03 has the potential to play a meaningful role in the treatment of
MDD patients."

 

The STARS-MDD study enrolled 80 adults, ages 25-55, who were stably treated
with an antidepressant medication yet were still experiencing mild to moderate
symptoms of depression as well as cognitive impairments. Patients were
randomized 1:1 to AKL-T03 or a digital control designed to have an equal
expectation of benefit. Results of the study demonstrated that the addition of
AKL-T03 to antidepressant therapy significantly improved sustained attention
in adults diagnosed with MDD compared to the control (p=0.005), as measured by
the Test of Variables of Attention (TOVA), which is a computerized test
cleared by FDA to assess attention deficits and evaluate the effects of
interventions in ADHD.

 

No treatment-related serious adverse events were reported, and two patients
(5.5%) reported headaches following treatment with AKL-T03. Results from the
STARS-MDD study were first presented at the 58th Annual Meeting of the
American College of Neuropsychopharmacology (ACNP) and are consistent with
those of prior research of Akili's study of AKL-T01 in patients with MDD,
published in Translational Psychiatry.(6)

 

"Addressing cognitive impairments associated with depression has been an area
of interest from healthcare professionals and companies over recent years, yet
options remain limited for patients,"  said Anil S. Jina M.D., Chief Medical
Officer of Akili. "Akili's technology is designed to target specific neural
networks related to attention function and this study demonstrates the
important role it could play in the treatment of patients with cognitive
dysfunction in depression."

 

AKL-T03 is an investigational medical device which has not been cleared by
FDA. It is built on Akili's SSME(TM) technology engine, which is designed to
address impairments in attention independent of disease. SSME presents
specific sensory stimuli and simultaneous motor challenges designed to target
the fronto-parietal cortex, an area of the brain which plays a key role in
attention function. This is the same technology embedded in AKL-T01, which has
been branded as EndeavorRx® and cleared by FDA to treat attention symptoms in
children ages 8-12 diagnosed with ADHD (see full indication below). AKL-T03
was adapted from AKL-T01 with a new game interface designed specifically for
an adult patient population.

 

About STARS-MDD

The Software Treatment for Actively Reducing the Severity of Cognitive
Deficits in Major Depressive Disorder (STARS-MDD)  study (NCT03310281) is a
randomized, double-blind, controlled study designed to assess the safety and
efficacy of AKL-T03 versus an expectation-matched digital control intervention
in an at-home setting. The study enrolled 80 adult patients between the ages
of 25 and 55 with a confirmed diagnosis of MDD according to DSM-5 criteria and
confirmed via the Mini International Neuropsychiatric Interview, version
7.0.2. Other key inclusion criteria included confirmation of a score between
14 and 22 on the 17-item Hamilton Depression Rating Scale (HAM-D) during the
screening phase (day -28) and at baseline (day 0) and  a symbol coding
T-score < 50 on the Brief Assessment of Cognition. Participants were
required to have been on antidepressant medication for > 8 weeks prior to
screening/baseline with a stable dosage for > 4 weeks prior to baseline.
Patients were randomized 1:1 to AKL-T03 or a digital control, both of which
were administered using Apple iPad mini 2 tablets. Participants in the AKL-T03
arm were instructed to complete five sessions, at least five days per week for
six weeks, for a total of approximately 25 minutes of game-play per day. The
software automatically locked after the five sessions were completed, to
preclude excessive use of the intervention. Participants assigned to the
control arm also were instructed to complete 25 minutes of game-play for at
least five days per week for six weeks; this software also automatically
locked after 25 minutes. The primary endpoint was a change from baseline in
cognitive performance following AKL-T03 intervention compared with the control
group, as measured by change in sustained attention using the TOVA reaction
time to rare target stimuli, normalized by age and sex. The TOVA is a
validated computerized continuous performance test of attention and inhibitory
control. Change from baseline scores from the first half of the TOVA between
day 0 (baseline) and day 42 (study exit) was compared between the two
intervention groups.

 

EndeavorRx® Indication and Overview

EndeavorRx® is indicated to improve attention function as measured by
computer-based testing in children ages 8 to 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. EndeavorRx associated adverse events in clinical trials
included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional
reaction (0.4%), nausea (0.4%), and aggression (0.2%). 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. To
learn more about EndeavorRx®, please visit EndeavorRx.com
(https://www.endeavorrx.com/) .

 

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
(http://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/) http://www.sec.gov (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 annual report on Form
10-K for the year ended December 31, 2021 filed with the SEC on March 24,
2022, 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 AKL-T03, Akili's
SSME(TM) technology engine, expectations around EndeavorRx, the proposed
business combination agreement between Akili and Social Capital Suvretta
Holdings Corp. I (Nasdaq: DNAA) or matters related thereto, 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.

 

(1) Anxiety and Depression Association of America
(https://adaa.org/understanding-anxiety/facts-statistics#:~:text=The%20leading%20cause%20of%20disability,older%20in%20a%20given%20year.)

(2 )Keefe RSE, McClintock SM, Roth RM, Doraiswamy PM, Tiger S, Madhoo M:
Cognitive effects of pharmacotherapy for major depressive disorder: A
systematic review. J Clin Psychiatry 2014; 75(8): 864-876.
(https://doi.org/10.4088/jcp.13r08609) https://doi.org/10.4088/jcp.13r08609
(https://doi.org/10.4088/jcp.13r08609)

(3 )Knight MJ, Mills NT, Baune BT: Contemporary methods of improving cognitive
dysfunction in clinical depression. Expert Rev Neurother 2019; 19(5):431-443.
(https://doi.org/10.1080/14737175.2019.1610395)
https://doi.org/10.1080/14737175.2019.1610395
(https://doi.org/10.1080/14737175.2019.1610395)

(4 )McIntyre R, Harrison J, Loft H, Jacobson W, Olsen CK:  The effects of
vortioxetine on cognitive function in patients with major depressive disorder:
A meta-analysis of three randomized controlled trials. Int J
Neuropsychopharmacol 2016; 19(10):pyw055.
(https://doi.org/10.1093/ijnp/pyw055) https://doi.org/10.1093/ijnp/pyw055
(https://doi.org/10.1093/ijnp/pyw055)

(5 )Gonda X, Pompili M, Serafini G, Carvalho A, Rihmer Z, Dome P: The role of
cognitive dysfunction in the symptoms and remission from depression. Ann Gen
Psychiatry 2015; 14:27. (https://doi.org/10.1186/s12991-015-0068-9)
https://doi.org/10.1186/s12991-015-0068-9
(https://doi.org/10.1186/s12991-015-0068-9)

(6 )Gunning F, Anguera J, Victoria L, Areán
(https://www.nature.com/articles/s41398-021-01386-8#auth-Patricia_A_-Are_n) P:
A digital intervention targeting cognitive control network dysfunction in
middle age and older adults with major depression, Translational Psychiatry
2021. (https://www.nature.com/articles/s41398-021-01386-8)
https://www.nature.com/articles/s41398-021-01386-8
(https://www.nature.com/articles/s41398-021-01386-8)

 

 Contact:

 PureTech

 Public Relations

 publicrelations@puretechhealth.com (mailto:publicrelations@puretechhealth.com)

 Investor Relations

 IR@puretechhealth.com (mailto:IR@puretechhealth.com)

 EU Media

 Ben Atwell, Rob Winder

 +44 (0) 20 3727 1000

 ben.atwell@FTIconsulting.com (mailto:ben.atwell@FTIconsulting.com)

 U.S. Media

 Nichole Sarkis

 +1 774 278 8273

 nichole@tenbridgecommunications.com
 (mailto:nichole@tenbridgecommunications.com)

 

 

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