TIDMPRTC
PureTech Health PLC
14 July 2022
14 July 2022
PureTech Health plc
PureTech Founded Entity Akili Announces the Journal Lupus
Publishes Investigator-Initiated Study Results Demonstrating
Improved Executive Function in Patients with Systemic Lupus
Erythematosus Following Use of AKL-T01 Product Candidate
Data show correlation between targeted activity in the brain and
improvement in motor speed and executive function, providing
further validation of Akili's technology platform and its potential
to improve select cognitive impairments across different
indications
Data also offer preliminary evidence of Akili's EVO(TM)
Monitor's ability to provide rapid mobile assessment of cognitive
function
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 publication of full
data from a randomized, unblinded study conducted by National
Jewish Health and the University of Colorado School of Medicine
Departments of Neurology, Psychiatry and Rheumatology that
evaluated the ability of Akili's digital therapeutic AKL-T01 to
improve cognitive dysfunction in patients diagnosed with Systemic
Lupus Erythematosus (SLE). Data from the study show that AKL-T01
resulted in significant improvement in motor speed and executive
functions. The study results were published in the medical journal
Lupus .
In the randomized, unblinded study of 60 SLE patients aged
18-65, participants showed a high adherence to the 4-week AKL-T01
treatment and showed significant improvement in visuomotor speed
(Trail Making A, p=0.025) and cognitive flexibility/sequencing
(Trail Making B, p=0.018) compared to the no contact control group.
Further, the study investigated the ability of the product EVO(TM)
Monitor(1) , built on the same technology platform, to serve as a
rapid mobile assessment of cognitive function.
At baseline, the multitasking threshold (reaction time
difference between single tasking and multitasking) from EVO(TM)
Monitor was associated with performance on tasks of cognitive
flexibility and psychomotor speed (Trail Making B, r=-0.37, p=0.001
and WAIS-IV coding, r=0.30, p=0.02). At follow up, the treatment
group also demonstrated significant improvement in EVO(TM) Monitor
compared to the control group (p=0.001). No additional between
groups differences were found in other neuropsychological,
behavioral, or health outcomes.
The full text of the announcement from Akili is as follows:
The Journal Lupus Publishes Investigator-Initiated Study Results
Demonstrating Improved Executive Function in Patients with Systemic
Lupus Erythematosus Following Use of Akili's AKL-T01 Product
Candidate
Data show correlation between targeted activity in the brain and
improvement in motor speed and executive function, providing
further validation of Akili's technology platform and its potential
to improve select cognitive impairments across different
indications
Data also offer preliminary evidence of EVO(TM) Monitor's
ability to provide rapid mobile assessment of cognitive
function.
BOSTON, Mass. - July 14, 2022 - Akili Interactive Labs, Inc.
("Akili"), a leading digital medicine company, today announced the
publication of full data from a randomized, unblinded study
conducted by National Jewish Health and the University of Colorado
School of Medicine Departments of Neurology, Psychiatry and
Rheumatology that evaluated the ability of Akili's digital
therapeutic AKL-T01 to improve cognitive dysfunction in patients
diagnosed with Systemic Lupus Erythematosus (SLE). Data from the
study show that AKL-T01 resulted in significant improvement in
motor speed and executive functions. The study results were
published in the medical journal Lupus .
Approximately 1.5 million people in the United States are living
with SLE.(2) Cognitive dysfunction occurs in 20% to 80% of patients
with SLE(3) , twice the prevalence of the general population,(4)
and substantially impacts their quality of life(5) .
In the randomized, unblinded study of 60 SLE patients aged
18-65, participants showed a high adherence to the 4-week AKL-T01
treatment and showed significant improvement in visuomotor speed
(Trail Making A, p=0.025) and cognitive flexibility/sequencing
(Trail Making B, p=0.018) compared to the no contact control group.
Further, the study investigated the ability of the product EVO(TM)
Monitor(1) , built on the same technology platform, to serve as a
rapid mobile assessment of cognitive function.
At baseline, the multitasking threshold (reaction time
difference between single tasking and multitasking) from EVO(TM)
Monitor was associated with performance on tasks of cognitive
flexibility and psychomotor speed (Trail Making B, r=-0.37,p=0.001
and WAIS-IV coding, r=0.30, p=0.02). At follow up, the treatment
group also demonstrated significant improvement in EVO(TM) Monitor
compared to the control group (p=0.001). No additional between
groups differences were found in other neuropsychological,
behavioral, or health outcomes.
"Cognitive difficulties such as attention and executive function
are linked to a number of autoimmune diseases, yet there are
limited assessments and few interventions to support them," said
Anil S. Jina M.D., Chief Medical Officer of Akili. "The results of
this study in patients with SLE are consistent with the cognitive
improvements seen in other studies after using our digital
therapeutic. We are excited to see this continued validation of our
technology platform as we advance our pipeline to deliver
clinically meaningful cognitive and quality-of-life improvements
across patient populations."
AKL-T01 is delivered through an action video game experience.
The 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 is built on Akili's Selective Stimulus Management Engine
(SSME(TM)), its most advanced proprietary therapeutic engine,
designed to target cognitive impairment at its source in the
brain.
SSME has been clinically validated across more than 20 research,
proof-of-concept and pivotal clinical studies in a number of
different disease areas to validate the efficacy and safety of
Akili's digital therapeutic solutions for the treatment of
cognitive impairments, including ADHD, multiple sclerosis (MS), and
Autism Spectrum Disorder (ASD).
Study Design
This was a randomized, unblinded study of 60 SLE patients aged
18-65. Study participants completed baseline neuropsychological
tests (of attention, psychomotor speed, and executive function), a
tablet-based digital assessment (EVO(TM) Monitor), and
biobehavioral measures. The patients were randomized into treatment
SLE (n=30) or no contact control SLE (n=30) groups, and returned
four weeks later for follow-up cognitive, EVO Monitor, and
biobehavioral testing. The SLE treatment group was trained on a
tablet-based digital treatment (AKL-T01) and were instructed to
complete 5 sessions at least 5 days per week for 4-weeks for a
total of approximately 25 minutes of gameplay per day.
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.
For more information, please visit www.akiliinteractive.com .
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(R) and digital medicine and the
benefits expected therefrom. 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 ability of Akili to successfully commercialize
EndeavorRx(R) and continue to advance its clinical development
pipeline, (ii) the ability of Akili to maintain relationships with
customers and suppliers and retain its management and key
employees, (iii) the evolution of the markets in which Akili
competes, (iv) the ability of Akili to defend its intellectual
property and satisfy regulatory requirements, (v) the impact of the
COVID-19 pandemic on Akili's business, (vi) Akili's expectations
regarding its market opportunities and (vii) the risk of downturns
and a changing regulatory landscape in the highly competitive
industry in which Akili operates. The foregoing list of factors is
not exhaustive. 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 assumes no obligation and
does not intend to update or revise these forward-looking
statements, whether as a result of new information, future events,
or otherwise. Akili does not give
any assurance that it 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 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.
(1) EVO(TM) Monitor incorporates a proprietary multi-tasking
assessment into a state-of-the-art mobile video game-like platform,
which deploys modern video game graphics, engaging reward loops,
and real-time adaptive mechanics to dynamically personalize
difficulty in order to assess the user's ability.
(2)
https://www.lupus.org/resources/lupus-facts-and-statistics.
(3) Hanly, JG, Harrison, MJ. Management of neuropsychiatric
lupus. Best Pract Res Cl Rh 2005; 19: 799-821.
(4) Ainiala, H, Loukkola, J, Peltola, J. The prevalence of
neuropsychiatric syndromes in systemic lupus erythematosus.
Neurology 2001; 57: 496-500.
(5) Mendelsohn S, Khoja L, Alfred S et al. Cognitive impairment
in systemic lupus erythematosus is negatively related to social
role participation and quality of life: a systematic review. Lupus
2021, 30:1617-1630
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 Sarkis
+1 774 278 8273
nichole@tenbridgecommunications.com
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