Akili to license TALi’s technology for use in
the U.S. as part of the agreement
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company today
announced that its Founded Entity, Akili Interactive (“Akili”),
maker of EndeavorRx®, the first and only prescription video game
treatment, and Australian digital health company TALi® (ASX:TD1),
(“TALi”), completed an agreement for Akili to license TALi’s
technology designed to address early childhood attention
impairments.
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the full release here:
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PureTech’s Founded Entity, Akili
Interactive, maker of EndeavorRx®, the first and only prescription
video game treatment, and Australian digital health company TALi®
(ASX:TD1), completed an agreement for Akili to license TALi’s
technology designed to address early childhood attention
impairments. (Photo: Business Wire)
The license is intended to build on the companies’ collective
clinical development experience and Akili’s success in bringing
EndeavorRx through the U.S. regulatory process and to market. The
companies plan to work together to execute clinical trials of the
TALi technology in pediatric ADHD in the United States and pursue
U.S. Food and Drug Administration (“FDA”) regulatory clearance.
Under the terms of the agreement, Akili will lead potential U.S.
commercialization and roll-out.
Through this agreement, Akili expects to expand its leadership
in prescription digital therapeutics (“PDTs”) for cognitive
impairments and chart a path for a new patient demographic to
benefit from innovative technologies proven to improve attention.
TALi’s technology builds on Akili’s product portfolio and
complements its flagship product EndeavorRx, which is FDA-cleared
to improve attention function in children ages 8-12 with ADHD (full
indication below).
The full text of the announcement from Akili is as follows:
Akili Enters Strategic Licensing Agreement
with TALi, Extending Akili Portfolio and Industry Leadership in
Prescription Digital Therapeutics for Cognitive Impairments
Through their shared focus on rigorous clinical
validation and high-end user experience, the companies will
continue to revolutionize the treatment of children with
attention-deficit/hyperactivity disorder (ADHD)
Akili will license TALi’s technology for use in
the U.S. in a deal estimated at $37.5M in future contingent
milestone payments plus royalties
BOSTON, Mass. and Melbourne, Australia – August 17, 2021
– Akili Interactive (“Akili”), a leading prescription digital
therapeutics company and maker of EndeavorRx®, the first and only
prescription video game treatment, and Australian Securities
Exchange listed digital health company TALi® (ASX:TD1), (“TALi”),
today announced they have completed an agreement for Akili to
license TALi’s technology designed to address early childhood
attention impairments.
TALi’s patented technology utilizes new mechanisms specifically
engineered to assess, target, and improve attention in early
childhood (ages 3-8) and is delivered through an engaging video
game experience. Combining over 25 years of research in
developmental psychology and cognitive neuroscience, TALi’s
training program has demonstrated improved attention in both
neurodiverse and neurotypical children, specifically showing
improvements in numeracy skills, gains in selective attention
skills, and behavioral improvements in a classroom setting. Study
data have been published in multiple peer-reviewed papers. The
technology is currently available in Australia, India, Singapore
and Hong Kong, marketed as TALi DETECT® (screening) and TALi TRAIN®
(attention training).
The terms of the deal, estimated at $37.5M in future contingent
milestone payments plus royalties on potential revenues, are
structured to leverage each organization’s expertise. Building on
their collective clinical development experience and Akili’s
success in bringing EndeavorRx through the U.S. regulatory process
and to market, the companies will work together to execute clinical
trials of the TALi technology in pediatric ADHD and pursue U.S.
Food and Drug Administration (FDA) regulatory clearance. Under the
terms of the agreement, Akili will lead U.S. commercialization and
roll-out.
Through this agreement, Akili is expanding its leadership in
prescription digital therapeutics (PDTs) for cognitive impairments
and charting a path for a new patient demographic to benefit from
innovative technologies proven to improve attention. TALi’s
technology builds on Akili’s product portfolio and complements its
flagship product EndeavorRx®, which is FDA-cleared to improve
attention function in children ages 8-12 with ADHD (full indication
below).
“Akili is continuously seeking opportunities to expand our suite
of targeted treatments for cognitive impairments, including through
strategic collaborations with companies that share our commitment
to delivering high-quality patient experiences built on scientific
rigor,” stated Eddie Martucci, PhD, Akili’s co-founder and CEO.
“Focused on early childhood intervention targeting attention,
TALi’s impressive technology is an ideal addition to Akili’s
portfolio. We are committed to changing the way people think about
medicine, and strategic agreements like this will allow us to
expand our vision to treat cognitive impairments in entirely new
ways and usher in the next generation of digital therapeutics.”
“Akili is leading the digital therapeutics industry with its
ability to dramatically scale into mainstream medicine while
maximizing value to patients and to the business, making it an
ideal partner for expanding the reach and impact of our
technology,” said Glenn Smith, Managing Director of TALi. “We’re
looking forward to working with the Akili team to provide solutions
that deliver digital-first support to the millions of children
living with attention issues.”
Understanding Prescription Digital Therapeutics
Prescription Digital Therapeutics (PDTs) are clinically validated
software-based interventions that prevent, manage, or treat a
medical disease or disorder. PDTs are approved by regulators and
available by prescription for use alone or alongside other
medications or medical devices. Akili is creating PDTs informed by
decades of neuroscience and cognitive research and delivered
through high-quality video game experiences to treat cognitive
impairments across multiple diseases and disorders.
EndeavorRx® Indication and Overview EndeavorRx is
the first-and-only FDA-cleared treatment delivered through a video
game experience. 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. To learn more about EndeavorRx, please visit
www.EndeavorRx.com.
About TALi Digital TALi [TALi Digital Limited (ASX: TD1)]
is an Australian digital health company delivering diagnostic and
therapeutic solutions for cognitive function and behavior. TALi’s
patented technology initially targets attention in early childhood
through its breakthrough evidence and video game-based TALi
screening (DETECT®) and training (TRAIN®) products. The targeting
of attention and early intervention underpins the TALi technology
that is allowing the company to develop a series of products across
multiple diseases and disorders. TALi solutions aim to deliver
foundational advances in human cognitive function and behavior only
dreamt of a few short years ago. For more information, please visit
www.talidigital.com
About Akili Akili is combining scientific and clinical
rigor with the ingenuity of the tech and entertainment industries
to challenge the status quo of medicine. Akili is pioneering the
development of digital treatments and care solutions to help people
affected by cognitive impairments. 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 treatments 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 26
therapeutics and therapeutic candidates, including two that have
received FDA clearance and European marketing authorization, as of
the date of PureTech’s most recently filed Annual Report on Form
20-F. 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 the
company's future prospects, developments, 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, expectations regarding the potential therapeutic benefits of
Akili’s therapeutic candidates, expectations regarding the benefits
of Akili’s licensing agreement with TALi, expectations regarding
terms of Akili’s licensing agreement with TALi, including the
execution of clinical trials of the TALi technology in pediatric
ADHD and pursuit of FDA regulatory clearance, potential
commercialization and 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210817005533/en/
Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com
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