Analyses of pooled efficacy data from the
EMERGENT program demonstrate significant improvements in
schizophrenia symptoms
Analyses extend prior findings that KarXT is
generally well tolerated with a low risk of common adverse events
associated with current antipsychotics, including somnolence,
weight gain, and movement disorders
Company submitted New Drug Application (NDA)
for KarXT for the treatment of schizophrenia to the U.S. Food &
Drug Administration (FDA) in September 2023
KarXT, a dual M1/M4 muscarinic agonist, would
represent the first new mechanism of action to treat schizophrenia
in several decades, if approved
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 it will be presenting new efficacy,
safety, and tolerability analyses from its EMERGENT program
evaluating KarXT (xanomeline-trospium) in adults with schizophrenia
at the upcoming Neuroscience Education Institute (NEI) Congress, to
be held November 9-12, 2023, in Colorado Springs, CO.
“In many patients, existing antipsychotics provide unreliable
relief from schizophrenia’s disabling symptoms and carry
undesirable side effects, amplifying the challenges of treatment
adherence and leaving such patients open to relapse. These new
findings bolster KarXT’s earlier data, demonstrating clinically
meaningful symptom reduction along with strong tolerability,” said
Stephen Brannan, M.D., chief medical officer of Karuna
Therapeutics. “Karuna will continue to gather data through our
EMERGENT clinical trial program to understand how KarXT’s novel
mechanism of action could meaningfully bridge current treatment
gaps for patients and their care partners.”
Details of the presentations are as follows:
- Poster Title: Efficacy of KarXT (Xanomeline–Trospium) in
Schizophrenia: Pooled Results From the Randomized, Double-Blind,
Placebo-Controlled EMERGENT Trials
- Poster Number: 32
- Date & Time: Friday, November 10, 3:15 – 4:45 p.m.
MT (5:15 – 6:45 p.m. ET)
- Presenter: Judy Kando, PharmD, BCPP, Executive Director,
Field Medical Lead, Medical Affairs, Karuna Therapeutics
- Poster Title: Safety and Tolerability of KarXT
(Xanomeline–Trospium): Pooled Results From the Randomized,
Double-Blind, Placebo-Controlled EMERGENT Trials
- Poster Number: 99
- Date & Time: Friday, November 10, 3:15 – 4:45 p.m.
MT (5:15 – 6:45 p.m. ET)
- Presenter: Judy Kando, PharmD, BCPP, Executive Director,
Field Medical Lead, Medical Affairs, Karuna Therapeutics
- Poster Title: Pooled Analysis of EPS-Like Symptoms in
the EMERGENT Program of KarXT in Schizophrenia
- Poster Number: 85
- Date & Time: Friday, November 10, 3:15 – 4:45 p.m.
MT (5:15 – 6:45 p.m. ET)
- Presenter: Peter Weiden, M.D., clinical professor of
psychiatry, Renaissance School of Medicine, Stony Brook
University
The company will also sponsor a symposium during the congress on
Friday, November 10th, from 6:45 – 7:45 p.m. MT (8:45 – 9:45 p.m.
ET), titled, “Forging a New Path: Targeting Muscarinic Receptor
Circuits in Schizophrenia.” The event will describe the complex
neurocircuitry of schizophrenia and the evolving class of
investigational therapeutics, which target acetylcholine muscarinic
receptors, and their potential to address unmet needs within the
treatment landscape.
In September 2023, the company filed an NDA for KarXT for the
treatment of schizophrenia in adults to the U.S. FDA. The NDA
submission is supported by efficacy and long-term safety data from
the EMERGENT program, the clinical program evaluating KarXT as a
treatment for schizophrenia. The EMERGENT program includes the
three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3
trials evaluating the efficacy and safety of KarXT compared to
placebo, and the EMERGENT-4 and EMERGENT-5 trials evaluating the
long-term safety of KarXT.
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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version on businesswire.com: https://www.businesswire.com/news/home/20231101134171/en/
Investors: Alexis Smith (617) 352-9917
asmith@karunatx.com
Media: Julie Ciardiello (917) 647-0159
julie.ciardiello@karunatx.com
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