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™ 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 EVOTM
Monitor1, 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 EVOTM
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 EVOTM 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™
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 SLE3, twice the prevalence of the general population,4 and
substantially impacts their quality of life5.
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 EVOTM
Monitor1, 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 EVOTM
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 EVOTM 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™), 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 (EVOTM
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®
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® 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™ 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
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U.S. Media Nichole Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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