Strong strategic and clinical progress in 2023,
with multiple catalysts expected in 2024
Launching of two new Founded Entities to
advance certain programs from the Wholly Owned Pipeline
Robust balance sheet position with estimated
Consolidated Cash, Cash Equivalents and Short-Term Investments at
year end of approximately $320 million1, extends operational runway
guidance into 2027
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company dedicated to
changing the lives of patients with devastating diseases, today
reports on the key progress made across its Wholly Owned Programs2
and Founded Entities3 in 2023, announces two new Founded Entities
and provides an update on cash and operational runway guidance.
Key Highlights:
- Strong progress in 2023 included the successful LYT-300
clinical trial of acute anxiety in healthy adults and initial data
from ongoing clinical trials of LYT-200 in solid tumors and acute
myeloid leukemia, along with Royalty Pharma deal of up to $500M, as
well as clinical and regulatory advances across multiple Wholly
Owned Programs and Founded Entities.
- PureTech continues to build and will further expand its Wholly
Owned Pipeline focus in pulmonary and rare diseases. Certain
GlyphTM intellectual property will remain at PureTech. Key
catalysts expected in 2024 include results from idiopathic
pulmonary fibrosis (IPF) late-stage trial of LYT-100 in Q4
2024.
- New clinical-stage neuroscience Founded Entity: Seaport
Therapeutics will advance certain central nervous system (CNS)
programs and relevant Glyph intellectual property. Rapid growth of
neuroscience pipeline, powered by Glyph platform, including new
therapeutic candidate announced today (LYT-320), and initiations of
two clinical trials in 2024 (LYT-300 and LYT-310).
- New clinical-stage oncology Founded Entity: Gallop Oncology to
advance LYT-200 and other galectin-9 intellectual property;
additional results from clinical trials in leukemia and solid
tumors expected in 2024.
- Robust balance sheet position with estimated Consolidated Cash,
Cash Equivalents and Short-Term Investments at year end of
approximately $320 million1, extends operational runway guidance
into 2027 based on the Company’s strategic operating plan.
- The PureTech Board may declare special dividends and/or share
buybacks as part of an overall returns strategy.
Daphne Zohar, Founder and Chief Executive Officer of PureTech,
commented: “PureTech has had a particularly productive year. One of
the advantages of the hub-and-spoke model we pioneered is that it
has enabled us to build an exciting pipeline of new medicines
poised for tremendous growth, without diluting our shareholders in
almost seven years. Our Founded Entities are a significant source
of value to us, and we have generated over $800 million in
non-dilutive proceeds to advance our pipeline and growth since
2020.
“A good example of how our successful model has funded our
pipeline and operations is our strategic deal with Royalty Pharma
acquiring an interest in our royalty in KarXT for up to $500
million, which provided us with upfront non-dilutive capital and
significant upside based on Karuna’s future regulatory and
commercial successes.
“I’m also proud of our track record which includes 80 percent4
success across clinical trials, with a probability of clinical
success that is six times better than the industry average5.
“Advancing programs to a key value inflection point before
determining the most expedient and cost-effective path forward is a
hallmark of our hub-and-spoke business model, and we’ve seen the
success of it realized in the U.S. FDA clearance of two medicines,
a third that has recently filed for approval, and several
additional therapeutic candidates being advanced through late-stage
clinical trials. This model allows us to create and advance new
medicines in a capital efficient manner. Importantly, the strategic
decision announced today to advance certain programs through two
new Founded Entities will make it easier for the true value of
these programs to be recognized and, as they continue to advance,
deliver the greatest value back to our shareholders.
“We are extremely proud of the numerous accomplishments made by
our team in 2023 and look forward to a productive and exciting
2024, where we expect to deliver multiple milestones to improve the
lives of patients and drive benefit to our shareholders.”
Additional highlights and progress include the following:
Outlook for 2024, new Founded Entities and execution of
corporate strategy
- Building on the success of early studies for LYT-100, and with
the important upcoming catalyst for IPF in 2024, PureTech will
continue to build on its internal expertise in pulmonary and rare
diseases and expanding its portfolio in those therapeutic areas.
Certain Glyph intellectual property will remain at PureTech.
- PureTech is reinforcing the proven success of its model by
adding two new “spokes” to the PureTech “hub.” PureTech will be
advancing its programs in two important therapeutic areas
(neuroscience and oncology respectively) in two new clinical-stage
Founded Entities, Seaport Therapeutics and Gallop Oncology.
- The launch of Seaport Therapeutics will accelerate the
development of new neuroscience medicines in areas of high unmet
need with the addition of capital partners to bring nearer-term
patient benefit. It also builds on the success PureTech has
achieved in the neuroscience arena with the same strategy and team
at PureTech that invented KarXT. If approved, KarXT will be the
third therapeutic candidate to be taken from inception at PureTech
to FDA regulatory approval and will represent the first new
mechanism of action for patients with schizophrenia in over 50
years.
- The launch of Gallop Oncology builds on the promising clinical
and preclinical data from PureTech’s LYT-200 program in solid
tumors and hematological malignancies. The development of a novel
oncology medicine requires a dedicated effort that is best enabled
through a separate Founded Entity and external capital.
Wholly Owned Programs
- LYT-100 (deupirfenidone) is currently in development for
the treatment of IPF, which is a rare, progressive, and fatal
disease. While existing standard-of-care treatments are effective,
they cause significant side effects, and as a result, three out of
four people living with IPF in the U.S. forego treatment. LYT-100,
which has shown 50 percent reduction of the GI and overall adverse
events compared to pirfenidone in a head-to-head study, has the
potential to both supplant the current standard-of-care treatments
and to serve a larger population of patients who are unable to
tolerate current therapies.
- Progressed a Phase 2b dose-ranging trial of LYT-100 in patients
with IPF. Topline results are expected in Q4 2024. PureTech plans
to pursue a streamlined development program for LYT-100 in IPF and
is using the same validated endpoints that have supported past
approvals. PureTech believes the results of the ongoing trial,
together with an additional registration study in Phase 3, could
serve as the basis for registration in the U.S. and other
geographies.
- Presented expanded data at the CHEST Annual Meeting 2023 from a
completed trial of LYT-100 in healthy older adults, which informed
the two doses selected for the ongoing Phase 2b trial (ELEVATE
IPF). In addition to supporting the improved tolerability of
LYT-100 versus the FDA-approved dose of pirfenidone, the new data
presented supported the selection of a higher dose of LYT-100 with
the potential for improved efficacy that is now being evaluated in
ELEVATE IPF.
Newly Announced Founded Entities:
- Seaport Therapeutics:
- LYT-300 (oral Glyph-allopregnanolone) is an oral prodrug
of allopregnanolone, enabled by the Glyph platform, that is
currently in development for the treatment of both neuropsychiatric
and rare CNS conditions. Allopregnanolone has demonstrated benefit
in a range of CNS conditions, but it can only be administered via
IV, which has hindered its broad therapeutic use. Using the Glyph
platform, LYT-300 retains the activity and potency of endogenous
allopregnanolone in an oral form.
- Successful topline results from a Phase 2a proof-of-concept
trial of LYT-300 using a validated clinical model of anxiety in
healthy volunteers were reported recently. Oral administration of
LYT-300 achieved the trial's primary endpoint of a statistically
significant reduction versus placebo in the increase from baseline
to peak levels of the stress hormone salivary cortisol (p=0.0001)
with a treatment effect size versus placebo of 0.72, measured by
the Cohen’s D.
- LYT-300 is advancing into a Phase 2 clinical trial for the
treatment of Fragile X-associated Tremor/ Ataxia Syndrome (FXTAS),
which is a rare neurological disease. A Phase 2 trial is expected
to initiate in 2024. PureTech was chosen to receive up to $11.4
million from the U.S. Department of Defense through a highly
competitive grant process to advance LYT-300 in FXTAS.
- LYT-310 (oral Glyph-cannabidiol [CBD]), is currently in
development for the treatment of epilepsies and other neurological
indications. A different CBD-based product purified from plant
sources, has received regulatory approval in the U.S. and Europe to
treat seizures resulting from certain rare conditions, but it
requires a large volume of a sesame oil-based formulation, which
limits its use in broader indications and age groups.
-
New today: Preclinical data demonstrated LYT-310 was
effective in preventing seizures in the Maximal Electroshock Model
(MES), a validated and highly translatable preclinical model
considered a gold standard for the assessment of anti-seizure
drugs. LYT-310 was tested against various formulations of CBD,
including an oral CBD formulation in sesame oil. LYT-310 showed
strong anti-seizure protection activity and was shown to be more
effective at preventing seizures at a dose three times lower than
an oral CBD formulation. Based on the data, LYT-310 has the
potential to expand the use of CBD to broader patient populations,
particularly in populations and conditions where higher doses are
required to achieve a therapeutic effect.
-
Initiation of a Phase 1 clinical trial of LYT-310 is expected in
the first half of 2024.
-
New today: LYT-320 (oral Glyph-agomelatine), was
nominated as a new therapeutic candidate powered by PureTech’s
Glyph platform. A novel prodrug of agomelatine, LYT-320 is in
development for the treatment of anxiety and mood disorders.
Anxiety disorders affect nearly 30 percent of U.S. adults6 and are
an area of significant unmet need.
- LYT-320 uses the Glyph platform to bypass first-pass metabolism
by the liver and thus has the potential to reduce liver exposure,
hepatotoxicity, and the need for liver function monitoring.
- Selective serotonin reuptake inhibitors (SSRIs) and serotonin
and norepinephrine reuptake inhibitors (SNRIs) are first-line
treatments for generalized anxiety disorder (GAD) and depressive
disorders but have side effects and efficacy limitations. A major
limitation of SSRIs and SNRIs are adverse events such as sexual
dysfunction and emotional blunting.
- Agomelatine acts through a completely different mechanism of
action and offers superior overall tolerability for patients
compared to standard-of-care. The drug has demonstrated clear human
efficacy in multiple studies of GAD where the gold-standard
Hamilton Anxiety Rating Scale (HAM-A) was used as the primary
endpoint. Agomelatine is approved for major depressive disorder
(MDD) in the European Union and for MDD and GAD in Australia.
Agomelatine has not been approved in the U.S., offering LYT-320
first-in-class potential for the U.S. market and best-in-class
potential in the rest of the world. However, agomelatine is
associated with hepatoxicity necessitating extensive liver function
monitoring that has held back its use. Agomelatine has very low
oral bioavailability (approximately one percent) due to extensive
hepatic first-pass metabolism, potentially contributing to
hepatoxicity.
- In multiple in vivo studies, LYT-320 showed oral
bioavailability and plasma exposures greater than 10-fold higher
than orally dosed agomelatine. Exposures comparable to approved
therapeutic agomelatine doses could thus be enabled by LYT-320
comprising a reduced dose of agomelatine, which in silico modeling
using the FDA-licensed DILIsym platform, has projected will greatly
reduce the risk of causing clinically significant liver enzyme
elevations.
- Initiation of first-in-human enabling studies is expected in
2024 and LYT-320 is expected to advance into clinical studies in
the first half of 2025.
-
Gallop Oncology:
- LYT-200 (anti-galectin-9 mAb) is in development for the
treatment of metastatic/locally advanced solid tumors, including
head and neck and urothelial cancers, and hematological
malignancies, such as acute myeloid leukemia (AML) and high-risk
myelodysplastic syndromes (MDS). A wide variety of preclinical data
support the potential clinical efficacy of LYT-200 and the
importance of galectin-9 as a target and suggests a potential
opportunity for biomarker development.
- Presented data from the ongoing Phase 1 clinical trial of
LYT-200 at the ESMO Immuno-Oncology Congress 2023. In the initial
results, LYT-200 demonstrated a favorable safety profile in all
cohorts, including the monotherapy and combination arms with
BeiGene’s tislelizumab, and showed disease control and suggestions
of initial anti-tumor activity. In the combination arm, 11 patients
have been dosed, and all evaluable patients treated so far include
four patients with head and neck cancers and two patients with
urothelial cancer. In the evaluable patients with head and neck
cancers, disease control was observed in three of the four
patients, with one patient experiencing a complete response after
nine months, one patient with a deepening partial response after
eight months, and one patient with disease stabilization at four
months so far, with treatment in these patients remains ongoing.
The two evaluable patients with urothelial cancer experienced
disease stabilization for seven months and three months, so far,
and both remain on treatment. The combination arm continues to
enroll patients with head and neck and urothelial cancers.
Completion of the trial and results are expected by the end of
2024.
- New today: In the ongoing Phase 1b trial evaluating
LYT-200 as a single agent in relapsed/refractory AML and MDS
patients, three dose escalation cohorts have completed to date at
weekly doses of 2 mg/kg (cohort 1), 4 mg/kg (cohort 2) and 7.5
mg/kg (cohort 3). In a heavily pre-treated patient population, the
early data demonstrates a favorable safety and tolerability profile
of LYT-200 with no dose limiting toxicities. In the first cohort,
disease stabilization was observed in two of the five patients
treated, with one patient achieving red blood cell transfusion
independence. In the second cohort, disease stabilization was
observed in two of the four patients treated. In the third cohort,
disease stabilization was observed in all four of the patients
treated, with a reduction in bone marrow blasts observed in two of
the four patients and the clearance of peripheral blasts observed
in one patient. Two patients achieved more than 50 percent bone
marrow blast reduction, with one of these patients observing an
increase in platelet count without transfusions. The fourth cohort,
evaluating a weekly regimen of LYT-200 at the 12 mg/kg dose, is
still ongoing. The part 2 portion of the Phase 1b trial evaluating
LYT-200 in combination with venetoclax and hypomethylating agents
is also ongoing. PureTech plans to present additional data from the
trial in a scientific forum in 2024.
Founded Entities:
- Karuna Therapeutics (Nasdaq: KRTX) (Karuna)
- Announced the U.S. Food and Drug Administration has accepted
its New Drug Application (NDA) for KarXT (xanomeline-trospium) for
the treatment of schizophrenia in adults. The application has been
granted a Prescription Drug User Fee Act (PDUFA) date of September
26, 2024.
- Announced positive results from its Phase 1b open-label,
eight-week inpatient trial evaluating the effect of KarXT on
24-hour ambulatory blood pressure in adults with schizophrenia
demonstrating that KarXT was not associated with increases in blood
pressure.
- The transaction of Karuna shares as described in this paragraph
constitutes a class 2 transaction for the purposes of the UK
Financial Conduct Authority’s Listing Rules. Since October 12,
2023, PureTech has raised aggregate proceeds of approximately $31.9
million, net of transaction fees, through the sale of shares of
Karuna in on-market transactions and the completion of call options
(collectively, the “Transaction”). PureTech also notes that it may,
but is not committing to, undertake sales of Karuna shares to
generate additional proceeds consistent with prior transactions at
its discretion. The proceeds of the Transaction are held by
PureTech as Cash and Cash Equivalents, and PureTech intends to use
the proceeds from the Transaction to further the advancement and
growth of the Company. Following the Transaction, PureTech holds
892,852 shares of Karuna common stock, which is equal to
approximately 2.4 percent of Karuna’s outstanding shares as of
October 31, 2023, with a market value of approximately $195.6
million as of December 19, 2023. Any future changes in our holdings
will be reflected through standard updates of our corporate
presentation and our other reporting. PureTech is also eligible to
receive up to $400 million in potential future milestone payments
from its deal with Royalty Pharma and retains the right to certain
royalty payments based on the sales of KarXT, as well as 20 percent
sublicense income covered by PureTech’s license agreement with
Karuna.
- Vedanta
- Dosed the first patient in the Phase 2 COLLECTiVE202 clinical
study of VE202 for the treatment of ulcerative colitis. The FDA
also granted Fast Track designation to VE202.
- Expects to initiate the Phase 3 RestoratiVE303 pivotal study of
VE303, designed for the prevention of recurrent Clostridioides
difficile infection, in the coming months.
- Vor (Nasdaq: VOR)
- Presented updated clinical data from patients treated in
VBP101, its Phase 1/2a multicenter, open-label, first-in-human
study of trem-cel (VOR33) in patients with acute myeloid leukemia
(AML) at the ASTCT/EBMT 6th International Conference on Relapse
After Transplant and Cellular Therapy (HSCT²). The additional data
demonstrated successful engraftment of trem-cel in all seven
patients treated to date with trem-cel. All three patients treated
with Mylotarg experienced hematologic protection and CD33-negative
donor cell enrichment with multiple cycles.
- Entrega
- Advanced its platform for the oral administration of biologics,
vaccines and other drugs that are otherwise not efficiently
absorbed when taken orally. Entrega's technology platform uses a
proprietary, customizable hydrogel dosage form to control local
fluid microenvironments in the GI tract to both enhance absorption
and reduce the variability of drug exposure. Peptide therapeutics
(e.g., the emerging GLP-1 agonist class) are ideally suited to
benefit from Entrega's approach.
- Demonstrated increased oral peptide bioavailability of two- to
three-fold over standard permeation enhancer formulations.
- Akili, Inc. (Nasdaq: AKLI) (Akili)
- Announced it received authorization from the U.S. FDA to expand
the label for EndeavorRxⓇ7 from 8 to 12 year-old patients with
primarily inattentive or combined-type
attention-deficit/hyperactivity disorder (ADHD) who have a
demonstrated attention issue to include older children aged 13-17.
This increased age range is expected to more than double the number
of pediatric patients with ADHD who are now eligible for
EndeavorRx.
- Announced its strategic plan to transition from a prescription
to a non-prescription business model. Akili also submitted a 510(k)
application to the FDA for EndeavorOTC8 as an over-the-counter
treatment for adults with ADHD.
- Announced it plans to submit data to the FDA to convert its
pediatric prescription product, EndeavorRx, to OTC in 2024.
- Announced topline results of the STARS-ADHD-Adult clinical
trial evaluating the efficacy and safety of EndeavorRx (AKL-T01) in
adults with ADHD. The results demonstrated attention improved in
more than 80 percent of adults with ADHD, and over one-third of
participants no longer exhibited an attention deficit following
treatment. Improvements in attention were nearly seven times larger
than those seen in the pivotal trial that supported EndeavorRx’s
FDA authorization for 8 to 12 year-olds with ADHD. Additionally,
nearly half of adults treated with EndeavorRx met a prespecified
threshold for clinically meaningful improvement in their quality of
life. EndeavorRx treatment was well-tolerated, with minimal side
effects and no serious device-related adverse events reported.
- Sonde Health
- Continued to scale its sales and revenue growth through
partnerships with several top health companies, providers, pharma
and device original equipment manufacturers. Sonde’s voice-based
artificial intelligence platform has now generated over 1.2 million
voice samples from more than 85,000 individuals on four
continents.
As part of PureTech’s distinctive approach to drug development,
which includes efficient de-risking and deprioritizing of programs
that don’t reach pre-specific thresholds for advancement, the
Company is no longer advancing its Alivio™ platform, including
therapeutic candidates LYT-500 and LYT-510, to pivot resources
towards the programs with the highest probability of success.
Additionally, PureTech announced in October that it would not be
moving forward with the previously contemplated plan of merger with
Gelesis.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to giving life to new classes of medicine to change the lives of
patients with devastating diseases. The Company has created a broad
and deep pipeline through its experienced research and development
team and its extensive network of scientists, clinicians and
industry leaders that is being advanced both internally and through
its Founded Entities. PureTech's R&D engine has resulted in the
development of 28 therapeutics and therapeutic candidates,
including two (Plenity® and EndeavorRx®) that have received both US
FDA clearance and European marketing authorization and a third
(KarXT) that has been filed for FDA approval. A number of these
programs are being advanced by PureTech or its Founded Entities in
various indications and stages of clinical development, including
registration enabling studies. 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.
For more information, visit www.puretechhealth.com or connect
with us on X (formerly 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 related to the Company’s LYT-100
development program and the timing for results from ongoing
clinical trials of LYT-100, the LYT-200 development program and the
timing for results from ongoing clinical trials of LYT-200, the
planned initiation of clinical trials for LYT-300, LYT-310 and
LYT-320, the potential therapeutic benefits of the therapeutic
candidates within Company’s Wholly Owned Programs, the Company’s
plan related to the prioritization of programs and activities
associated with its pipeline, the Company’s approach to potential
partnerships or spinouts of its platforms or candidates, the
Company’s plans to maintain a minimum of three years of cash on
hand, the Company’s plans to return capital to shareholders and its
future prospects, developments 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 the following: our history of incurring significant
operating losses since our inception; our need for additional
funding to achieve our business goals, which may not be available
and which may force us to delay, limit or terminate certain of our
therapeutic development efforts; our limited information about and
limited control or influence over our Founded Entities; the
generally lengthy and expensive process of preclinical and clinical
drug development, which has an uncertain outcome and potential for
substantial delays; potential difficulties with enrolling patients
in clinical trials, which could delay our clinical development
activities; side effects, adverse events or other safety risks
which could be associated with our therapeutic candidates and delay
or halt their clinical development; our ability to obtain
regulatory approval for and commercialize our therapeutic
candidates; our ability to realize the benefits of our
collaborations, licenses and other arrangements; our ability to
maintain and protect our intellectual property rights; our reliance
on third parties, including clinical research organizations,
clinical investigators and manufacturers; our vulnerability to
natural disasters, global economic factors, geo-political actions
and unexpected events; our ability to achieve future monetization
events; limitations on our ability to pay cash to shareholders;
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, 2022 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 The preliminary selected financial
results reported by the Company are unaudited, subject to
adjustment, and provided as an approximation in advance of the
Company’s announcement of complete financial results in April
2024.
2 References to “Wholly Owned Programs”
refer to the Company’s five therapeutic candidates (LYT-100,
LYT-200, LYT-300, LYT-310 and LYT-320), Glyph platform and
potential future therapeutic candidates and platforms that the
Company may develop or obtain. References to "Wholly Owned
Pipeline" refer to LYT-100, LYT-200, LYT-300, LYT-310 and LYT-320.
Certain of the Wholly Owned Programs and certain assets within the
Wholly Owned Pipeline are being advanced through the newly
announced Founded Entities Seaport Therapeutics, Inc. and Gallop
Oncology, Inc.
3 Founded Entities represent companies
founded by PureTech in which PureTech maintains ownership of an
equity interest and, in certain cases, is eligible to receive
sublicense income and royalties on product sales. As of the date of
this release, PureTech maintained control over Entrega, Inc. by
virtue of majority voting control and the right to elect
representation to the entity’s Board of Directors. PureTech also
controls Seaport Therapeutics, Inc. and Gallop Oncology, Inc. As of
the date of this release, PureTech did not have a controlling
interest in Karuna Therapeutics, Inc., Akili, Inc., Sonde Health,
Inc., Vedanta Biosciences, Inc. and Vor Biopharma Inc.
4 The percentage includes number of
successful trials out of all trials run for all therapeutic
candidates advanced through at least Phase 1 by PureTech or its
Founded Entities from 2009 onward.
5 Industry average data measures the
probability of clinical trial success of therapeutics by
calculating the number of programs progressing to the next phase
vs. the number progressing and suspended (Phase 1=52%, Phase 2=29%,
Phase 3=58%). BIO, PharmaIntelligence, QLS (2021) Clinical
Development Success Rates 2011 –2020. This study did not include
therapeutics regulated as devices.
6 Any Anxiety Disorder. (n.d.). National
Institute of Mental Health (NIMH).
https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder
7 EndeavorRx is the first-and-only
FDA-authorized treatment delivered through a video game experience.
EndeavorRx is indicated to improve attention function as measured
by computer-based testing in children ages 8 to 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 trials 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.
8 EndeavorOTC is a digital therapeutic
indicated to improve attention function, ADHD symptoms and quality
of life in adults 18 years of age and older with primarily
inattentive or combined-type ADHD. EndeavorOTC utilizes the same
proprietary technology underlying EndeavorRx, a prescription
digital therapeutic indicated to improve attention function in
children ages 8-12. EndeavorOTC is available under the U.S. Food
and Drug Administration's current Enforcement Policy for Digital
Health Devices for Treating Psychiatric Disorders During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
EndeavorOTC has not been cleared or authorized by the U.S. Food and
Drug Administration for its indications. It is recommended that
patients speak to their health care provider before starting
EndeavorOTC treatment. No serious adverse events have been reported
in any of our clinical studies. To learn more, visit
EndeavorOTC.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231219893762/en/
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 Bobbyn +1 774 278 8273
nichole@tenbridgecommunications.com
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