KarXT demonstrated statistically significant
and clinically meaningful improvements in positive and negative
symptoms of schizophrenia compared to placebo, as measured by
primary and secondary endpoints
KarXT was generally well tolerated and not
associated with many adverse events typically associated with
current antipsychotics, including somnolence, weight gain and
extrapyramidal symptoms
New Drug Application for KarXT for the
treatment of schizophrenia in adults was recently accepted with a
Prescription Drug User Fee Act (PDUFA) action date of September 26,
2024
If approved, KarXT, a dual M1/M4 muscarinic
agonist, would represent the first new pharmacological approach to
treating schizophrenia in several decades
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 that results from the Phase 3
EMERGENT-2 trial of KarXT (xanomeline-trospium) in adults with
schizophrenia were published in The Lancet. The manuscript shares
KarXT data showcasing a clinically meaningful and statistically
significant reduction in positive and negative symptoms of
schizophrenia among adult patients experiencing acute psychosis,
alongside a distinct tolerability profile.
“Having such robust data showcased in one of the world’s most
prestigious medical journals attests to the potential of KarXT’s
novel mechanism of action to redefine the treatment landscape for
the millions grappling with schizophrenia’s disabling symptoms,”
said Steve Paul, M.D., president of research and development and
chief scientific officer of Karuna Therapeutics and co-author on
the manuscript. “The data published in our manuscript continue to
reinforce our confidence in KarXT as we look ahead to the results
of our ongoing trials, including EMERGENT-4 and EMERGENT-5, which
will provide a longer-term view of the efficacy and safety of KarXT
in people living with schizophrenia.”
The Phase 3 EMERGENT-2 trial was a double-blind,
placebo-controlled, five-week inpatient trial that enrolled 252
adults with schizophrenia in the United States. Participants were
randomized 1:1 to receive a twice-daily, flexible dose of KarXT or
placebo. In the trial, KarXT demonstrated a statistically
significant and clinically meaningful 9.6-point reduction in
Positive and Negative Syndrome Scale (PANSS) total score compared
to placebo (-21.2 KarXT vs. -11.6 placebo, p<0.0001) at week 5,
the primary outcome measure of the study. Results published in The
Lancet also include data for all the pre-specified secondary
outcome measures: change in PANSS positive subscale, PANSS negative
subscale, PANSS Marder negative factor, Clinical Global
Impression-Severity score, and percentage of participants achieving
a ≥30% reduction from baseline to week 5 in PANSS total score,
where KarXT demonstrated statistically significant reductions
compared to placebo at week 5 (p<0.05) on each endpoint.
KarXT was generally well tolerated, with overall discontinuation
rates similar to placebo (KarXT 25% vs. placebo 21%).
Discontinuation rates due to treatment-emergent adverse events
(TEAEs) were also similar between KarXT and placebo (7% vs. 6%,
respectively). The most common KarXT TEAEs (≥5% and at least twice
the rate of placebo) were constipation, dyspepsia, nausea,
vomiting, hypertension, dizziness, and gastroesophageal reflux
disease (acid reflux). The majority of common TEAEs occurred in the
first two to three weeks of treatment, were transient, and resolved
before the end of the trial (week 5). The data from EMERGENT-2
suggests that KarXT may have a distinctive safety and tolerability
profile, as it was not associated with many of the adverse events
typically associated with current antipsychotic treatments,
including somnolence, weight gain and extrapyramidal motor
symptoms.
“Coming off the heels of our NDA acceptance of KarXT for the
treatment of schizophrenia, this publication in The Lancet further
validates KarXT’s potential as an alternative to currently
available treatment options that block dopamine receptors,” said
Inder Kaul, MD, MPH, senior vice president of clinical development
at Karuna Therapeutics and lead author of the manuscript. “For the
first time in decades, a potential new therapeutic option presents
the possibility of treating schizophrenia symptoms, perhaps without
the burden of many of the side effects commonly associated with
current antipsychotics.”
“New treatments and novel mechanisms are urgently needed for
people with schizophrenia because many don’t respond to their
therapy and others only have a partial improvement in symptoms or
intolerable side effects,” said Rishi Kakar, M.D., chief scientific
officer and medical director of Segal Trials, an author of the
manuscript, and lead investigator of the Phase 3 EMERGENT-2 trial.
“The antipsychotic activity and differentiated safety and
tolerability profile demonstrated in EMERGENT-2, and the other
completed EMERGENT trials, provide hope to the healthcare community
and patients that KarXT may provide a much-needed new way to treat
those living with schizophrenia.”
The published manuscript, titled “Efficacy and safety of the
muscarinic receptor agonist KarXT (xanomeline–trospium) in
schizophrenia (EMERGENT-2): results from a randomized,
double-blind, placebo-controlled, flexible-dose phase 3 trial in
the United States,” is available online and will appear in the
print issue of The Lancet at a later date.
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 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. 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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Investors: Alexis Smith (617) 352-9917
asmith@karunatx.com
Media: Julie Ciardiello (917) 647-0159
julie.ciardiello@karunatx.com
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