Japanese Product Now Under Review for
Nationwide Marketing Approval
PureTech Health plc (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, 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.
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.
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.
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 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.
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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
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