Pivotal study follows successful Phase 2 trial,
which demonstrated improvements in attention function as compared
to both treatment as usual and single task video game groups
Pivotal Data Readout expected in 2H2023
PureTech Health plc (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
digital medicine company, today announced the start of a pivotal
Phase 3 randomized, controlled study of SDT-001 (a version of
AKL-T01 localized for Japanese language and culture), a product
candidate designed to improve measures of attention in children
diagnosed with attention-deficit/hyperactivity disorder (“ADHD”).
The study, conducted by Akili’s partner, global pharmaceutical
company Shionogi & Co., Ltd. (“Shionogi”), is designed to
evaluate the safety and efficacy of the product candidate in
children ages 6-17 with ADHD as a registration-enabling trial.
Clinical trial sites have begun enrolling patients, and results of
the study are expected in 2H2023.
This study represents the first pivotal study of Akili’s video
game-based cognitive treatment outside of the U.S. SDT-001 was
developed specifically for use in the Japanese market, adapting
Akili’s AKL-T01 for Japanese language and culture. The disease
agnostic proprietary technology is designed to treat impaired
cognitive function, specifically attention control. Delivered
through an action video game experience, this innovative 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 pivotal study of SDT-001 is being conducted across multiple
sites in Japan and is expected to enroll approximately 150 children
ages 6-17 years diagnosed with ADHD. The study design was informed
by Shionogi’s successful Phase 2 study of SDT-001.
Branded and marketed as EndeavorRx® in the U.S., AKL-T01 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 attention and inhibitory control deficits in
pediatric ADHD. Please see below for full indication and safety
information.
The full text of the announcement from Akili is as follows:
Shionogi Begins Phase 3 Study in Japan of
Akili’s Digital Treatment in Children with ADHD
Pivotal study follows successful Phase 2 trial,
which demonstrated improvements in attention function as compared
to both treatment as usual and single task video game groups.
Pivotal Data Readout expected in 2H2023
BOSTON, Mass. – August 1, 2022 – Akili Interactive
(“Akili”), a leading digital medicine company, today announced the
start of a pivotal Phase 3 randomized, controlled study of SDT-001
(a version of AKL-T01 localized for Japanese language and culture),
a product candidate designed to improve measures of attention in
children diagnosed with attention-deficit/hyperactivity disorder
(“ADHD”). The study, conducted by Akili’s partner, global
pharmaceutical company Shionogi & Co., Ltd. (“Shionogi”), is
designed to evaluate the safety and efficacy of the product
candidate in children ages 6-17 with ADHD as a
registration-enabling trial. Clinical trial sites have begun
enrolling patients, and results of the study are expected in
2H2023.
“ADHD has a significant impact on children and their families in
Asia, and caregivers and health care providers are looking for
innovative non-drug treatment options. Following our successful
Phase 2 study of SDT-001, we are excited to advance Akili’s product
candidate through the clinical process to potentially help the
millions of children living in Japan with ADHD,” said Takeki
Uehara, Corporate Officer, Senior Vice President, Drug Development
and Regulatory Science Division of Shionogi & Co., Ltd.
“We are thankful to our partners at Shionogi who share our
commitment to patients and have initiated this pivotal study ahead
of schedule,” said Anil S. Jina M.D., Chief Medical Officer of
Akili. “This trial is an important step towards our goal to help
all eligible children with ADHD across the globe, irrespective of
their language, culture, or geographic location.”
The pivotal study of SDT-001 is being conducted across multiple
sites in Japan and is expected to enroll approximately 150 children
ages 6-17 years diagnosed with ADHD. The study design was informed
by Shionogi’s successful Phase 2 study of SDT-001. It consists of
two parts, a comparison part and a repetition part.
- Comparison part: Qualifying participants are randomized to
either 1) receive SDT-001 in addition to treatment as usual
(“TAU”), consisting of psychoeducation and environmental support,
or 2) continue TAU.
- Repetition part: After completing the comparison part, both
groups receive SDT-001.
Participants who receive SDT-001 treatment use the digital
intervention for approximately 25 minutes per day, seven days per
week for a total of six weeks of treatment. Following treatment,
participants’ attention function is assessed by physicians using
the ADHD-RS-IV inattentive subscale, a commonly used scale in
evaluating ADHD treatments, and compared to baseline.
This study represents the first pivotal study of Akili’s video
game-based cognitive treatment outside of the U.S. SDT-001 was
developed specifically for use in the Japanese market, adapting
Akili’s AKL-T01 for Japanese language and culture. The disease
agnostic proprietary technology is designed to treat impaired
cognitive function, specifically attention control. Delivered
through an action video game experience, this innovative 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.
AKL-T01 has been evaluated across five clinical studies in more
than 600 children diagnosed with ADHD, including a prospective,
randomized, controlled study published in The Lancet Digital
Health. The technology is also being studied by Akili in multiple
other indications with associated chronic and acute cognitive
impairments, including autism spectrum disorder (“ASD”), multiple
sclerosis, major depressive disorder, COVID-19 brain fog,
cancer-related cognitive impairment and postoperative cognitive
dysfunction. Branded and marketed as EndeavorRxⓇ in the U.S.,
AKL-T01 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 attention and inhibitory control
deficits in pediatric ADHD. Please see below for full indication
and safety information.
In September 2021, Akili and Shionogi announced the results of a
Phase 2 study of SDT-001 in Japan. The study enrolled a total of
261 children ages 6-17 years diagnosed with ADHD and evaluated
their attention impairment using the ADHD RS-IV Inattention scale,
comparing those who received the Akili treatment to those receiving
TAU and those who received a control app (single task video game).
The SDT-001 treatment group showed larger improvements across the
clinical endpoints compared to both the TAU and the control app
groups. In the total population, the improvements seen over the
control app did not meet statistical significance, but post hoc
analysis applying the propensity score suggested that SDT-001
improvements over TAU were statistically significant. 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.
Akili and Shionogi formed a strategic partnership in May 2019
for the commercialization of Akili’s AKL-T01 and AKL-T02, as
potential treatments of cognitive impairments in children with ADHD
and ASD, respectively, in Japan and Taiwan. The partnership
leverages each party’s distinct expertise to build a novel
commercial model and seek to 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® Indication and Overview EndeavorRx is the
first prescription video game treatment granted marketing
authorization by the FDA. 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®)
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.
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.
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
document that serves as a prospectus and proxy statement of SCS,
referred to as a proxy statement/prospectus. The Registration
Statement became effective on July 21, 2022. SCS has mailed a
definitive proxy statement/prospectus and other relevant documents
to its shareholders of record as of July 14, 2022, the record date
established for the extraordinary general meeting of SCS
shareholders relating to the proposed transaction. The proxy
statement/prospectus has been distributed to SCS’s shareholders in
connection with SCS’s solicitation of proxies for the vote by SCS’s
shareholders with respect to the proposed transaction. SCS may also
file other documents regarding the proposed transaction with the
SEC. BEFORE MAKING ANY VOTING DECISION, 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.
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. 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 and
include statements regarding Akili’s expectations for EndeavorRx®
and digital medicine, the development of its platform and the
launch of EndeavorRx®, its partnership with Shionogi and the
benefits expected therefrom, including the timing and results
expected from its pivotal Phase 3 trial of SDT-001. 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, (xx) the risk of
downturns and a changing regulatory landscape in the highly
competitive industry in which Akili operates and (xxi) the timing
and results expected from Akili and its partners' clinical trials.
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 quarterly report on Form 10-Q for the quarter ended March 31,
2022 filed with the SEC on May 16, 2022, the Registration
Statement, 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 27
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
Annual 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 unique insights in immunology and drug development.
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 the Phase 3
study of Akili’s SDT-001 to be conducted by Shionogi and
expectations related to the timing of results from the study,
Akili’s proposed business combination transaction with Social
Capital Suvretta Holdings Corp. I, and Akili’s 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, 2021
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 Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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