TIDMPRTC
PureTech Health PLC
29 September 2021
29 September 2021
PureTech Health plc
PureTech Founded Entity Akili Announces Topline Results from
Shionogi Phase 2 Study in Japan
Shionogi successfully completes first-ever clinical study of
Akili's video game-based cognitive treatment outside of the U.S.;
plans to advance technology to the next step
Data show Akili's digital treatment was well-received and
improved inattention in children with ADHD
Results demonstrate high engagement and similar magnitude of
improvements as seen in prior studies of AKL-T01 in ADHD
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company, is pleased to
note that its Founded Entity, Akili Interactive ("Akili"), today
announced topline results of a Phase 2 study of SDT-001 (Japanese
version of AKL-T01), a digital therapeutic designed to improve
measures of attention in children diagnosed with
attention-deficit/hyperactivity disorder (ADHD). The study,
conducted by Akili partner Shionogi & Co., Ltd. ("Shionogi"),
was designed to evaluate the feasibility, safety and efficacy of
the digital therapeutic in children with ADHD and to inform the
design of a potential pivotal study.
To enable this clinical trial, Akili localized its AKL-T01
technology for use in the Japanese market, which included adapting
for language and culture and establishing infrastructure in Japan
to support the product. Results show the treatment was
well-received by patients and demonstrated improvements in ADHD
inattention symptoms consistent with those seen across previous
studies of AKL-T01. Based on these results, Shionogi plans to
advance SDT-001 into consultation with the Japanese regulatory
authority PMDA regarding Phase 3 implementation.
Akili and Shionogi formed a strategic partnership in May 2019
for the commercialization of Akili's digital medicines, AKL-T01 and
AKL-T02, as treatments of cognitive impairments in children with
ADHD and Autism Spectrum Disorder (ASD), respectively, in Japan and
Taiwan. Under the terms of the agreement, Akili received upfront
payments totaling $20 million with potential milestone payments for
Japan and Taiwan commercialization of up to an additional $105
million, in addition to substantial royalties on product sales.
Shionogi will also help fund development costs. Shionogi has
exclusive rights to the clinical development and is responsible for
regulatory filings, sales and marketing of the technologies in
Japan and Taiwan. Akili is responsible for building and maintaining
R&D and commercial platforms designed specifically for digital
therapeutics, including all global product development activities,
distribution and technical support services. Akili will maintain
exclusive global rights to develop and commercialize AKL-T01 and
AKL-T02 in all territories outside of Japan and Taiwan.
AKL-T01, branded EndeavorRx , is cleared for use by the U.S.
Food and Drug Administration (FDA) and has received Conformité
Européenne (CE) Mark certification in Europe for use in pediatric
ADHD. Please see below for full indication information on
EndeavorRx and visit EndeavorRx.com to learn more.
The full text of the announcement from Akili is as follows:
Topline Results from Shionogi Phase 2 Study in Japan Show
Akili's Digital Treatment Was Well-received and Improved
Inattention Symptoms in Children with ADHD
Shionogi successfully completes first-ever clinical study of
Akili's video game-based cognitive treatment outside of the U.S.;
plans to advance technology to the next step
Results demonstrate high engagement and similar magnitude of
improvements as seen in prior studies of AKL-T01 in ADHD
BOSTON, Mass. September 29, 2021, -- Akili Interactive
("Akili"), a leading cognitive medicine company improving health
through game-changing technologies, today announced topline results
of a Phase 2 study of SDT-001 (Japanese version of AKL-T01), a
digital therapeutic designed to improve measures of attention in
children diagnosed with attention-deficit/hyperactivity disorder
(ADHD). The study, conducted by Akili partner Shionogi & Co.,
Ltd. ("Shionogi"), was designed to evaluate the feasibility, safety
and efficacy of the digital therapeutic in children with ADHD and
to inform the design of a potential pivotal study. Results show the
treatment was well-received by patients and demonstrated
improvements in ADHD inattention symptoms consistent with those
seen across previous studies of AKL-T01. Based on these results,
Shionogi plans to advance SDT-001 into consultation with the
Japanese regulatory authority PMDA regarding Phase 3
implementation.
"This study marks the first time a clinical trial of Akili's
technology has been conducted outside of the U.S., and we thank our
partners at Shionogi who are helping us to develop this new
treatment option for families of children with ADHD in Japan. We're
pleased to not only see a meaningful treatment effect that
continues to validate our core technology, but also high engagement
in the treatment," said Anil S. Jina M.D., Chief Medical Officer of
Akili. "Our goal is for all eligible children across the globe to
be able to access our attention treatment, regardless of their
spoken language and geographic location, this study represents an
incredibly important milestone."
The randomized, controlled study of SDT-001 was conducted in
Japan and enrolled children ages 6-17 years diagnosed with ADHD
whose ADHD RS-IV Inattention score was 15 or over . A total of 262
patients were enrolled across three study groups: 1) participants
who received the Akili SDT-001 digital treatment, 2) participants
who continued treatment as usual (TAU), consisting of
psychoeducation and environmental support, and 3) participants who
received a version of the treatment with reduced cognitive tasks
and adaptability ("Sham"). The SDT-001 treatment group showed
larger improvements across the clinical endpoints compared to both
the TAU and the Sham groups. In the total population, the
improvements seen over Sham did not meet statistical significance,
but post hoc analysis applying the propensity score suggested that
SDT-001 improvements over TAU were statistically significant. While
full data are still being analyzed, early data showed additional
SDT-001 efficacy compared to both Sham and TAU groups in specific
subsets of children, including those with inattentive-type
ADHD.
SDT-001 was well-tolerated and there were no serious adverse
events. Adverse events reported were consistent with previous
clinical studies of the digital treatment. Adverse device reactions
were reported in 4 patients (3.7%) treated with SDT-001 and were
mild in severity including irritability, somnolence, tinnitus and
nausea.
To enable this clinical trial, Akili localized its AKL-T01
technology for use in the Japanese market, which included adapting
for language and culture and establishing infrastructure in Japan
to support the product. The technology is a disease agnostic
proprietary technology designed to treat impaired cognitive
function, specifically attention control. Delivered through an
action video game experience, this first-in-class technology
presents specific sensory stimuli and simultaneous motor challenges
designed to target and activate the neural systems that play a key
role in attention function while using adaptive algorithms to
personalize the treatment experience for each individual patient.
The technology has been evaluated as a potential treatment for
cognitive impairments associated with nearly a dozen different
disease areas and has been studied in more than 2600 patients
across 30 clinical trials. AKL-T01, branded EndeavorRx , is cleared
for use by the U.S. Food and Drug Administration (FDA) and has
received Conformité Européenne (CE) Mark certification in Europe
for use in pediatric ADHD. Please see below for full indication
information on EndeavorRx and visit EndeavorRx.com to learn
more.
Akili and Shionogi formed a strategic partnership in May 2019
for the commercialization of Akili's digital medicines, AKL-T01 and
AKL-T02, as treatments of cognitive impairments in children with
ADHD and Autism Spectrum Disorder (ASD), respectively, in Japan and
Taiwan. The partnership leverages each party's distinct expertise
to build a novel commercial model and launch the new class of
treatment to patients. Under the terms of the agreement, Shionogi
has exclusive rights to the clinical development and is responsible
for regulatory filings, sales and marketing of the technologies in
Japan and Taiwan. Akili is responsible for building and maintaining
R&D and commercial platforms designed specifically for digital
therapeutics, including all global product development activities,
distribution and technical support services. Akili maintains
exclusive global rights to develop and commercialize AKL-T01 and
AKL-T02 in all territories outside of Japan and Taiwan.
EndeavorRx (R) Indication and Overview
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. To learn more
about EndeavorRx, please visit EndeavorRx.com .
About Shionogi
Shionogi & Co., Ltd. is a major research-driven
pharmaceutical company dedicated to bringing benefits to patients
based on its corporate philosophy of "supplying the best possible
medicine to protect the health and wellbeing of the patients we
serve." Shionogi's research and development currently target two
therapeutic areas: infectious diseases and psycho-neurological
diseases. Shionogi is committed to "improve social productivity and
extend healthy lifespans" as the key focus. We will endeavor to
deliver breakthrough treatments for the patients of
psycho-neurological diseases including ADHD, which still have high
unmet medical needs, and contribute to improving the QOL of
patients and their families. For more details, please visit
www.shionogi.com/global/en/ .
About Akili
Akili is pioneering the development of game-changing
technologies to usher in a new era of cognitive medicine. Focused
on delivering cutting-edge digital diagnostics, treatments and
monitors for cognitive impairments across disease and disorders,
Akili is combining scientific and clinical rigor with the ingenuity
of the tech and entertainment industries and challenging the status
quo of medicine. Akili's treatments are designed to directly
activate the networks in the brain responsible for cognitive
function and have been rigorously tested in extensive clinical
studies, including prospective randomized, controlled trials.
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 .
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, including statements that relate to our
expectation regarding the use of Akili's AKL-T01 technology in the
Japanese market, Shionogi's plans to initiate a Phase 3 trial for
SDT-001 in Japan and the associated timing, and Akili's future
prospects, development plans, and strategies. The forward-looking
statements are based on current expectations and are subject to
known and unknown risks and uncertainties that could cause actual
results, performance and achievements to differ materially from
current expectations, including, but not limited to those risks and
uncertainties described in the risk factors included in the
regulatory filings for PureTech Health plc. 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, neither the company
nor any other party intends to update or revise these
forward-looking statements, whether as a result of new information,
future events or otherwise.
Contact:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
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