RCS - PureTech Health PLC - PRTC: Akili Positive Ph3 & Japan PMDA Submission

Puretech HealthAnnouncement

27/02/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240227:nRSa5212Ea&default-theme=true

RNS Number : 5212E  PureTech Health PLC  27 February 2024

27 February 2024

PureTech Health plc

 

PureTech Founded Entity Akili Announces Positive Results from Shionogi's Phase
3 Clinical Trial of Localized Version of Akili's EndeavorRx ® for Pediatric
ADHD Patients in Japan

 

Japanese Product Now Under Review for Nationwide Marketing Approval

 

PureTech Health plc (https://puretechhealth.com/) (Nasdaq: PRTC, LSE: PRTC)
("PureTech" or the "Company"), a clinical-stage biotherapeutics company
dedicated to changing the lives of patients with devastating diseases, noted
that its Founded Entity Akili, Inc. (Nasdaq: AKLI) announced that its Japanese
partner Shionogi & Co. Ltd has submitted Akili's digital therapeutic
SDT-001 for marketing approval with the Ministry of Health, Labor, and
Welfare. SDT-001 is the Japanese, localized version of Akili's AKL-T01
(marketed as EndeavorRx® in the United States), which has previously been
authorized by the U.S. Food and Drug Administration (FDA) as the world's first
prescription digital therapeutic for improving attentional functioning in
pediatric ADHD patients aged 8 to 17.

 

"We are pleased by this additional validation of Akili's EndeavorRx," said
Eric Elenko, Ph.D., Chief Innovation Officer at PureTech. "This game-changing
technology is now poised to address the needs of pediatric patients with ADHD
in Japan if approved, and this exciting milestone is yet another example of
PureTech's contribution to changing the lives of patients in need."

 

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

 
Akili Announces Positive Results from Shionogi's Phase 3 Clinical Trial of Localized Version of Akili's EndeavorRx® for Pediatric ADHD Patients in Japan
 

Japanese Product Now Under Review for Nationwide Marketing Approval

 

BOSTON--Akili
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.akiliinteractive.com%2F&esheet=53900146&newsitemid=20240222202566&lan=en-US&anchor=Akili&index=1&md5=719099d8cbf99c31392503f75453ae5f)
, Inc. (Nasdaq: AKLI), a leading digital medicine company, today announced
that its Japanese partner Shionogi & Co. Ltd has submitted Akili's digital
therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor,
and Welfare. SDT-001 is the Japanese, localized version of Akili's AKL-T01
(marketed as EndeavorRx(®) in the United States), which has previously been
authorized by the U.S. Food and Drug Administration (FDA) as the world's first
prescription digital therapeutic for improving attentional functioning in
pediatric ADHD patients aged 8 to 17.

 

"The latest Japanese clinical trial of our patented, clinically proven
technology is an important milestone for many reasons," said Dr. Scott
Kollins, Chief Medical Officer at Akili. "It not only further validates the
efficacy and safety of EndeavorRx, it also moves us and our international
partner SHIONOGI a step closer to making the product available in Japan. And
if approved in Japan, it will provide an effective and safe option in a
country where some front line pharmaceutical therapies are not as widely
available to pediatric patients with ADHD."

 

The submission for marketing approval in Japan is based on the favorable
results of the Phase 3 clinical trial conducted by SHIONOGI in the country.
The trial aimed to evaluate the efficacy and safety of SDT-001 in 164
pediatric ADHD patients aged 6 to 17 who received conventional treatments such
as environmental adjustments and psychosocial therapies. The SDT-001 group,
undergoing approximately 25 minutes of treatment once daily for 6 weeks (1
cycle), demonstrated statistically significant improvements in the change from
baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale IV
(ADHD-RS-IV) Inattention score compared to the control group (continuing
conventional treatments) at the 6-week mark (p < 0.05), achieving the
primary endpoint of the trial. Moreover, statistically significant
improvements were observed in the change from baseline in the total ADHD-RS-IV
score and the hyperactivity/impulsivity score at the 6-week mark in the
SDT-001 group compared to the control group (p < 0.05). No safety concerns
or serious adverse events related to SDT-001 were observed. Furthermore,
symptom improvements were sustained even after two cycles of SDT-001 use, with
no safety concerns noted.

 

About Shionogi & Co. Ltd

SHIONOGI is committed to realizing the SHIONOGI Group Vision of "Building
Innovation Platforms to Shape the Future of Healthcare" by transforming into a
"Healthcare as a Service (HaaS)" company. While enhancing our strengths as a
research-based pharmaceutical company, we aim to provide diverse treatment
options beyond medicinal products, including collaborations with external
partners, to contribute to improving the quality of life for patients and
their families.

 

About EndeavorRx and EndeavorOTC

Akili's suite of cognitive treatment products for ADHD includes EndeavorRx and
EndeavorOTC(®). EndeavorRx is indicated to improve attention function as
measured by computer-based testing in children ages 8 to 17 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 trials 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. To learn more about EndeavorRx, please
visit EndeavorRx.com
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2FEndeavorRx.com&esheet=53900146&newsitemid=20240222202566&lan=en-US&anchor=EndeavorRx.com&index=3&md5=e662ba4c91ebd68efb919e52a64589e5)
.

 

EndeavorOTC is a digital therapeutic indicated to improve attention function,
ADHD symptoms and quality of life in adults 18 years of age and older with
primarily inattentive or combined-type ADHD. EndeavorOTC utilizes the same
proprietary technology underlying EndeavorRx, a prescription digital
therapeutic indicated to improve attention function in children ages 8-17.
EndeavorOTC is available under the U.S. Food and Drug Administration's current
Enforcement Policy for Digital Health Devices for Treating Psychiatric
Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency. EndeavorOTC has not been cleared or authorized by the U.S. Food and
Drug Administration for any indications. It is recommended that patients speak
to their health care provider before starting EndeavorOTC treatment. No
serious adverse events have been reported in any of our clinical studies. To
learn more, visit EndeavorOTC.com
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2FEndeavorOTC.com&esheet=53900146&newsitemid=20240222202566&lan=en-US&anchor=EndeavorOTC.com&index=4&md5=f2d01891069ac4243d3dbdae35373b41)
.

 

About Akili

Akili is pioneering the development of cognitive treatments through
game-changing technologies. Akili's 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. For more information, please
visit www.akiliinteractive.com
(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.akiliinteractive.com&esheet=53900146&newsitemid=20240222202566&lan=en-US&anchor=www.akiliinteractive.com&index=5&md5=5b076d72758998c3d601b372e9a44868)
.

 

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995, as amended. These
forward-looking statements generally are identified by the words "believe,"
"project," "expect," "anticipate," "estimate," "intend," "strategy," "future,"
"opportunity," "plan," "prepare," "pursue," "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. These
forward-looking statements include, without limitation, statements in this
press release related to: initial results from the Phase 3 trial conducted by
our partner SHIONOGI of our SDT-001 digital therapeutic; our expectations
regarding our partner SHIONOGI's plans, and regarding PMDA's potential
authorization of, our SDT-001 digital therapeutic in Japan; and our
expectation regarding SDT-001's potential, if approved, to provide a safe and
effective treatment option to pediatric patients with ADHD in Japan; and other
risks identified in our current filings and any subsequent filings made with
the Securities and Exchange Commission (SEC). We caution you not to place
undue reliance on any forward-looking statements, which speak only as of the
date hereof and should not be relied upon as representing our views as of any
subsequent date. We disclaim any obligation to publicly update or revise any
such statements to reflect any change in expectations or in events, conditions
or circumstances on which any such statements may be based, or that may affect
the likelihood that actual results will differ from those set forth in the
forward-looking statements.

 

Akili, EndeavorRx, and EndeavorOTC are registered trademarks of Akili, Inc.
Other trademarks are trademarks or registered trademarks of their respective
owners. All rights reserved.

 

About PureTech Health

PureTech is a clinical-stage biotherapeutics company dedicated to giving life
to new classes of medicine to change the lives of patients with devastating
diseases. The Company has created a broad and deep pipeline through its
experienced research and development team and its extensive network of
scientists, clinicians and industry leaders that is being advanced both
internally and through its Founded Entities. PureTech's R&D engine has
resulted in the development of 28 therapeutics and therapeutic candidates,
including two (Plenity® and EndeavorRx®) that have received both US
FDA clearance and European marketing authorization and a third (KarXT) that
has been filed for FDA approval. A number of these programs are being advanced
by PureTech or its Founded Entities in various indications and stages of
clinical development, including registration enabling studies. 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.

 

For more information, visit www.puretechhealth.com
(http://www.puretechhealth.com/)  or connect with us on X (formerly 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 related to initial results from the Phase 3
trial conducted by Akili's partner SHIONOGI of Akili's SDT-001 digital
therapeutic; Akili's expectations regarding its partner SHIONOGI's plans and
regarding PMDA's potential authorization of Akili's SDT-001 digital
therapeutic in Japan; and Akili's expectation regarding SDT-001's potential,
if approved, to provide a safe and effective treatment option to pediatric
patients with ADHD in Japan, and our future prospects, developments 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, 2022 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@puretechhealth.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 Bobbyn

 +1 774 278 8273

 nichole@tenbridgecommunications.com

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAZZGZZGVLGDZZ