Karuna Therapeutics Announces Positive Results from Phase 1b Ambulatory Blood Pressure Monitoring Trial of KarXT in Schizophrenia
17 November 2023 - 8:01AM
Business Wire
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
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.
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