TIDMPRTC
PureTech Health PLC
25 February 2021
25 February 2021
PureTech Health plc
PureTech Founded Entity Karuna Therapeutics Announces New
England Journal of Medicine Publication of Data from EMERGENT-1
Phase 2 Trial Evaluating KarXT in Schizophrenia
KarXT demonstrated statistically significant and clinically
meaningful improvements in primary and key secondary efficacy
measures compared with placebo
Incidences of somnolence, weight gain and extrapyramidal
symptoms were similar in KarXT and placebo treatment groups
KarXT is in Phase 3 clinical development for the treatment of
psychosis in adults with schizophrenia
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases , is pleased to note that its
Founded Entity, Karuna Therapeutics, Inc. (NASDAQ: KRTX), a
clinical-stage biopharmaceutical company driven to create and
deliver transformative medicines for people living with psychiatric
and neurological conditions, announced that results from the
EMERGENT-1 Phase 2 clinical trial evaluating KarXT for the
treatment of schizophrenia were published in the New England
Journal of Medicine (NEJM).
The published manuscript titled "Muscarinic Cholinergic Receptor
Agonist and Peripheral Antagonist for Schizophrenia" is available
online and appears in the February 25, 2021 issue of NEJM.
The full text of the announcement from Karuna is as follows:
Karuna Therapeutics Announces New England Journal of Medicine
Publication of Data from EMERGENT-1 Phase 2 Trial Evaluating KarXT
in Schizophrenia
KarXT demonstrated statistically significant and clinically
meaningful improvements in primary and key secondary efficacy
measures compared with placebo
Incidences of somnolence, weight gain and extrapyramidal
symptoms were similar in KarXT and placebo treatment groups
KarXT is in Phase 3 clinical development for the treatment of
psychosis in adults with schizophrenia
BOSTON, February 24, 2021 - Karuna Therapeutics, Inc. (NASDAQ:
KRTX), a clinical-stage biopharmaceutical company driven to create
and deliver transformative medicines for people living with
psychiatric and neurological conditions, today announced that
results from the EMERGENT-1 Phase 2 clinical trial evaluating KarXT
for the treatment of schizophrenia were published in the New
England Journal of Medicine (NEJM).
"The publication of the EMERGENT-1 Phase 2 trial results in the
peer-reviewed New England Journal of Medicine reinforces earlier
clinical and preclinical data that KarXT's modulation of muscarinic
receptor function in the brain improves the symptoms of psychosis
in schizophrenia, and underscores the potential of KarXT to offer a
novel approach to treating this serious and disabling condition,"
said Steve Brannan, M.D., chief medical officer of Karuna
Therapeutics and lead author of the manuscript. "These findings
support the potential for KarXT to treat symptoms of psychosis in
schizophrenia without producing the common problematic side effects
of current therapies, such as weight gain and extrapyramidal
symptoms. Given these encouraging results, we have advanced KarXT
into Phase 3 clinical development in our efforts to provide a
meaningful, new, non-dopaminergic treatment option for this serious
neuropsychiatric disorder affecting more than 21 million people
worldwide."
The double-blind, placebo-controlled, five-week inpatient
EMERGENT-1 Phase 2 trial enrolled 182 adults with an acute
exacerbation of schizophrenia. In this trial, a twice-daily,
flexible-dose treatment with KarXT demonstrated a statistically
significant and clinically meaningful 11.6-point reduction in the
Positive and Negative Syndrome Scale (PANSS) total score compared
to placebo at Week 5, the primary outcome measure of the study,
with an effect size of 0.75 (p<0.0001). Results published in
NEJM also include data for pre-specified secondary outcome
measures. Four of the five pre-specified secondary outcome
measures, including PANSS positive symptom subscore, PANSS negative
symptom subscore, PANSS Marder negative symptom subscore, and
Clinical Global Impression - Severity frequency counts, showed
statistically significant reductions following treatment with KarXT
compared to placebo at Week 5 (p<0.001).
KarXT was generally well-tolerated, with similar discontinuation
rates between KarXT and placebo arms, both overall (20% vs. 21%)
and due to treatment-emergent adverse events (2% in both arms). The
most common adverse events associated with KarXT, including
constipation, nausea, dry mouth, dyspepsia and vomiting, were
mild-to-moderate in severity and were not associated with treatment
discontinuation. Rates of nausea, vomiting, and dry mouth decreased
over the course of the trial, while rates of constipation remained
essentially constant. Incidences of somnolence, weight gain and
extrapyramidal symptoms, which are common problematic side effects
of current antipsychotic therapies, were similar in the placebo and
KarXT treatment groups.
"Many people living with schizophrenia have persistent symptoms,
experience poor quality of life and impaired ability to function,
despite treatment with current antipsychotic drugs," said Jeffrey
Lieberman, M.D., professor and chairman of the Department of
Psychiatry, Columbia University, College of Physicians and
Surgeons, member of Karuna's scientific advisory board, and
co-author of the manuscript. "The clinical trial results with KarXT
highlight its potential to be a differentiated treatment option
with a completely new mechanism of action for people living with
schizophrenia, offering relief from acute psychotic symptoms
without the debilitating side effects associated with the current
standard of care."
The published manuscript titled "Muscarinic Cholinergic Receptor
Agonist and Peripheral Antagonist for Schizophrenia," is available
online , and will appear in the February 25, 2021 issue of
NEJM.
About KarXT
KarXT, a proprietary oral modulator of muscarinic cholinergic
receptors, is Karuna's lead product candidate. It combines
xanomeline, a novel muscarinic agonist, with trospium, an
FDA-approved muscarinic antagonist that does not appreciably cross
the blood-brain-barrier, to preferentially stimulate muscarinic
receptors in the central nervous system. This novel product
candidate, if approved, has the potential to usher in a new
treatment paradigm and dramatically impact patients with
schizophrenia and other psychotic disorders by providing a
differentiated mechanism of action relative to current D2 dopamine
and serotonin receptor-targeting antipsychotic drugs.
About Schizophrenia
Schizophrenia is a chronic and often disabling brain condition
affecting how a person thinks, feels and behaves. It is estimated
to affect more than 21 million people worldwide, and has a young
age at onset, typically presenting during late adolescence to early
adulthood. Symptoms of schizophrenia generally fall into three
categories - positive (delusions, hallucinations, and difficulty
organizing and expressing thoughts), negative (difficulty enjoying
life and withdrawal from others) and cognitive (deficits in memory,
concentration and decision making). Given the nature of these
symptoms, schizophrenia can affect all areas of patients' lives.
Many people living with schizophrenia have difficulty finding an
effective treatment and continue to experience distressing
symptoms. With the help of a dedicated treatment team, it is
possible for people with schizophrenia to live full lives. New
therapeutic options with different mechanisms of action will enable
more patients to find an effective and safe treatment regimen.
About Karuna
Karuna Therapeutics is a clinical-stage biopharmaceutical
company driven to create and deliver transformative medicines for
people living with psychiatric and neurological conditions. At
Karuna, we understand there is a need for differentiated and more
effective treatments that can help patients navigate the challenges
presented by these severe and disabling disorders. Utilizing our
extensive knowledge of neuroscience, we are harnessing the untapped
potential of the brain in pursuit of novel pathways to develop
medicines that make meaningful differences in peoples' lives. For
more information, please visit www.karunatx.com .
Forward Looking Statements
This press release contains forward looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, including statements regarding our expectations about the
timing of advancing of our planned clinical trials and regulatory
filings, our goals to develop and commercialize our product
candidates, and other statements identified by words such as
"could," "expects," "intends," "may," "plans," "potential,"
"should," "will," "would," or similar expressions and the negatives
of those terms. Forward-looking statements are not promises or
guarantees of future performance, and are subject to a variety of
risks and uncertainties, many of which are beyond our control, and
which could cause actual results to differ materially from those
contemplated in such forward-looking statements. These factors
include risks related to our limited operating history, our ability
to obtain necessary funding, our ability to generate positive
clinical trial results for our product candidates, the timing and
scope of regulatory approvals, changes in laws and regulations to
which we are subject, competitive pressures, risks relating to
business interruptions resulting from the coronavirus (COVID-19)
pandemic, and other risks set forth under the heading "Risk
Factors" of our Annual Report on Form 10-K for the year ended
December 31, 2019 and our Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020. Our actual results could differ
materially from the results described in or implied by such
forward-looking statements. Forward-looking
statements speak only as of the date hereof, and, except as
required by law, we undertake no obligation to update or revise
these forward-looking statements.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
intractable cancers, lymphatic and gastrointestinal diseases,
central nervous system disorders and inflammatory and immunological
diseases, 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,
as of the date of PureTech's most recently filed Registration
Statement on Form 20-F, was comprised of 24 products and product
candidates, including two that have received FDA clearance and
European marketing authorization. All of the underlying programs
and platforms that resulted in this pipeline of product 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, our expectations regarding the potential therapeutic benefits
of our product candidates, our expectations regarding the results
from Karuna's EMERGENT-1 Phase 2 clinical trial evaluating KarXT
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.
Contact:
Investors EU media
Allison Mead Talbot Ben Atwell, Rob Winder
+1 617 651 3156 +44 (0) 20 3727 1000
amt@puretechhealth.com ben.atwell@FTIconsulting.com
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