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 (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.
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
|