Results demonstrate KarXT was not associated
with clinically meaningful increases in blood pressure in adults
with schizophrenia
KarXT demonstrated a mean change from baseline
to week 8 in 24-hour ambulatory systolic blood pressure of -0.59
mmHg, the primary endpoint in the trial
KarXT was generally well tolerated, with a side
effect profile consistent with prior trials in the EMERGENT program
evaluating KarXT in schizophrenia
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company, noted that
its Founded Entity, Karuna Therapeutics (NASDAQ: KRTX), announced
positive results from its Phase 1b open-label, eight-week inpatient
trial evaluating the effect of KarXT (xanomeline-trospium) on
24-hour ambulatory blood pressure in adults with schizophrenia
demonstrating that KarXT was not associated with increases in blood
pressure.
The primary endpoint in the trial was the change from baseline
at week 8 in 24-hour average ambulatory systolic blood pressure. In
the trial, KarXT demonstrated a mean change from baseline to week 8
in 24-hour ambulatory systolic blood pressure of -0.59 mmHg. The
upper bound of the two-sided 95% confidence interval for the mean
change from baseline to week 8 was 1.60 mmHg, thus ruling out a
clinically meaningful increase in blood pressure (defined per FDA
guidance as ≥3 mmHg change from baseline). Daytime and nighttime
systolic blood pressure measurements showed no meaningful change
and were generally consistent with the 24-hour average. Additional
vital sign measures collected in the trial, including 24-hour
average diastolic blood pressure and heart rate, were consistent
with prior trials of KarXT in schizophrenia. Further, KarXT was
generally well tolerated, with a side effect profile consistent
with prior trials in the EMERGENT program.
PureTech is a founder of Karuna and co-inventor of the KarXT
program. In September 2023, Karuna announced the submission of a
New Drug Application to the U.S. Food and Drug Administration for
KarXT for the treatment of schizophrenia. If approved, KarXT will
be the third therapeutic candidate to be taken from inception at
PureTech to FDA regulatory approval.
The full text of the announcement from Karuna is as follows:
Karuna Therapeutics Announces Positive
Results from Phase 1b Ambulatory Blood Pressure Monitoring Trial of
KarXT in Schizophrenia
Results demonstrate KarXT was not associated
with clinically meaningful increases in blood pressure in adults
with schizophrenia
KarXT demonstrated a mean change from baseline
to week 8 in 24-hour ambulatory systolic blood pressure of -0.59
mmHg, the primary endpoint in the trial
KarXT was generally well tolerated, with a side
effect profile consistent with prior trials in the EMERGENT program
evaluating KarXT in schizophrenia
BOSTON -- Nov. 16, 2023 -- Karuna Therapeutics, Inc.
(NASDAQ: KRTX), a biopharmaceutical company driven to discover,
develop, and deliver transformative medicines for people living
with psychiatric and neurological conditions, today announced
positive results from its Phase 1b open-label, eight-week inpatient
trial evaluating the effect of KarXT (xanomeline-trospium) on
24-hour ambulatory blood pressure in adults with schizophrenia
demonstrating that KarXT was not associated with increases in blood
pressure.
The primary endpoint in the trial was the change from baseline
at week 8 in 24-hour average ambulatory systolic blood pressure. In
the trial, KarXT demonstrated a mean change from baseline to week 8
in 24-hour ambulatory systolic blood pressure of -0.59 mmHg. The
upper bound of the two-sided 95% confidence interval for the mean
change from baseline to week 8 was 1.60 mmHg, thus ruling out a
clinically meaningful increase in blood pressure (defined per FDA
guidance as ≥3 mmHg change from baseline). Daytime and nighttime
systolic blood pressure measurements showed no meaningful change
and were generally consistent with the 24-hour average. Additional
vital sign measures collected in the trial, including 24-hour
average diastolic blood pressure and heart rate, were consistent
with prior trials of KarXT in schizophrenia. Further, KarXT was
generally well tolerated, with a side effect profile consistent
with prior trials in the EMERGENT program.
“The data from the trial confirms our findings from the EMERGENT
trials that suggested KarXT is not associated with a sustained
increase in blood pressure in adults with schizophrenia,” said
Steve Brannan, M.D., chief medical officer of Karuna Therapeutics.
“These results provide a more definitive characterization of the
cardiovascular safety profile of KarXT, which substantiates the
existing clinical data to date and will supplement our NDA as part
of the Day 120 safety update, along with additional safety data,
pending filing acceptance.”
The ambulatory blood pressure monitoring trial was designed in
line with FDA guidance (Assessment of Pressor Effects of Drugs,
Guidance for Industry, February 2022) to provide an accurate
assessment of the potential pressor effects of KarXT over a 24-hour
period using ambulatory monitoring at baseline and at week 8 in
adults with schizophrenia. A total of 133 adults (between the ages
of 30-65 years) with a confirmed diagnosis of schizophrenia were
enrolled in the trial. Trial participants received a flexible dose
of KarXT two times a day (BID) for up to eight weeks. Consistent
with the EMERGENT program, nearly 80% of trial participants
titrated to and remained at the highest dose level of KarXT 125/30
(125mg xanomeline/30mg trospium) BID.
About KarXT
KarXT (xanomeline-trospium) is an investigational muscarinic
antipsychotic in development for the treatment of schizophrenia and
psychosis related to Alzheimer’s disease. Through its novel
mechanism of action, KarXT acts as a dual M1/M4 muscarinic
acetylcholine receptor agonist in the central nervous system, which
is thought to improve positive, negative, and cognitive symptoms of
schizophrenia. Unlike existing treatments, KarXT does not directly
block dopamine receptors, representing a potential new approach to
treating schizophrenia.
About Schizophrenia
Schizophrenia is a persistent and often disabling mental illness
impacting how a person thinks, feels, and behaves, and affects
nearly 24 million people worldwide, including 2.8 million people in
the U.S. It is characterized by three symptom domains: positive
symptoms (hallucinations and delusions), negative symptoms
(difficulty enjoying life and withdrawal from others), and
cognitive impairment (deficits in memory, concentration, and
decision-making). In part due to limitations with current
treatments, people living with schizophrenia often struggle to
maintain employment, live independently, and manage relationships.
While current treatments can be effective in managing select
symptoms, approximately 30% of people do not respond to therapy,
with an additional 50% experiencing only a partial improvement in
symptoms or unacceptable side effects.
About Karuna Therapeutics
Karuna Therapeutics is a biopharmaceutical company driven to
discover, develop, 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 serious mental illness. 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 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. Such statements
include, but are not limited to, statements relating to our
acceptance by the FDA of our pending New Drug Application (NDA) and
statements relating to our belief in the clinical significance of
the data from this study to support the NDA submission. 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 and other risks
inherent in clinical development, the timing and scope of
regulatory approvals, changes in laws and regulations to which we
are subject, competitive pressures, our ability to identify
additional product candidates, risks relating to business
interruptions, and other risks set forth under the heading “Risk
Factors” of our Annual Report on Form 10-K for the year ended
December 31, 2022 and in our subsequent filings with the Securities
and Exchange Commission. 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 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 27 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 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 results of the Phase 1b Ambulatory Blood Pressure
Monitoring Trial of KarXT in Schizophrenia or their clinical
significance in relation to Karuna’s pending New Drug Application
(NDA) for KarXT, the FDA’s potential acceptance of Karuna’s pending
NDA, and Karuna's and PureTech's 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, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231116001299/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 Sarkis +1 774 278 8273
nichole@tenbridgecommunications.com
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