Long-term treatment with KarXT was
associated with continued improvements in symptoms of schizophrenia
across all efficacy measures at 52 weeks
More than 75% of participants achieved
>30% improvement in symptoms from
baseline, as measured by the Positive and Negative Syndrome Scale
(PANSS) total score, at one year
Participants previously on placebo in acute
trials experienced significant reduction of symptoms beginning at
week two and maintained throughout treatment
Bristol Myers Squibb (NYSE: BMY) today announced new interim
results from the Phase 3 EMERGENT-4 open-label extension trial
evaluating the long-term efficacy, safety and tolerability of KarXT
(xanomeline-trospium) in adults with schizophrenia. Long-term
efficacy data from the trial were presented in a poster titled,
“Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in
Schizophrenia” (Poster F264) at the Annual Congress of the
Schizophrenia International Research Society (SIRS) being held
April 3-7, 2024, in Florence, Italy.
“We are pleased to see a continued and consistent meaningful
reduction in symptoms of schizophrenia across 52-weeks in an
outpatient setting, beyond what was seen in the short-term,
in-patient five-week trials (EMERGENT-2 and EMERGENT-3),” said
Roland Chen, MD, senior vice president and head, Immunology,
Cardiovascular and Neuroscience development, Bristol Myers Squibb.
“We look forward to continued conversations with the FDA and to
sharing additional data from the EMERGENT program later this
year.”
EMERGENT-4 is a Phase 3, 52-week, outpatient, open-label
extension study evaluating the long-term safety, tolerability, and
efficacy of KarXT in adults with schizophrenia who previously
completed the treatment period of one of the Phase 3, five-week,
double-blind, placebo-controlled, efficacy and safety studies,
EMERGENT-2 or EMERGENT-3. At the time of the data cutoff of April
17, 2023, 110 patients were part of the interim efficacy analysis,
with 29 patients having completed 52 weeks of treatment.
In the interim analysis, KarXT was associated with significant
improvement in symptoms of schizophrenia across all efficacy
measures at 52 weeks. At the end of the open-label extension, more
than 75% of participants achieved >30% improvement in symptoms, with an average
reduction of 33.3-points from baseline (98.4), as measured by the
Positive and Negative Syndrome Scale (PANSS) total score. In
addition, participants had a mean 1.7-point change in Clinical
Global Impression-Severity (CGI-S) score from baseline (5.2),
representing an average shift from ‘markedly ill’ at baseline to
‘moderately’ or ‘mildly’ ill at one year.
Improvements in symptoms of schizophrenia continued throughout
the 52-week trial regardless of whether participants were
previously treated with KarXT or placebo during the acute trials.
Prior to enrolling in the open-label extension, participants who
previously received placebo in EMERGENT-2 and EMERGENT-3 had a
significantly higher mean PANSS total score compared to those who
received KarXT (placebo 86.5 vs. KarXT 76.1). When dosed with
KarXT, the patients previously on placebo had significant
improvements in symptoms within two weeks of treatment with KarXT.
After four weeks, PANSS total scores were comparable between those
who received KarXT or placebo in the acute trials.
“These interim data from EMERGENT-4 continue to validate the
potential of KarXT in the long-term management of schizophrenia,
with continued benefit across 52 weeks of treatment,” said Elan
Cohen, Ph.D., principal investigator, CenExel Hassman Research
Institute and investigator in the EMERGENT program. “The
consistency of efficacy results across all EMERGENT clinical trial
programs is encouraging and suggest KarXT could provide a
differentiated treatment approach for people living with
schizophrenia.”
In additional data presented at the congress, KarXT demonstrated
a favorable impact on weight and long-term metabolic profile where
most patients experienced stability or improvements on metabolic
parameters over 52 weeks of treatment. In long-term trials, KarXT
was generally well tolerated, with a side effect profile consistent
with prior trials of KarXT in schizophrenia. KarXT was not
associated with significant changes related to prolactin or
clinically meaningful changes in movement disorder scale scores
over 52 weeks (Oral Session: New Pharmacological Treatments and
Assessments and Poster F74).
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.
Bristol Myers Squibb: Delivering Breakthrough Science for
Meaningful Interventions in Neuroscience Neurological
conditions represent some of the greatest challenges of our time
because of their impact on society, including patients, caregivers,
families and healthcare systems. At Bristol Myers Squibb, we are
committed to advancing our robust pipeline of potential medicines
for neurological disorders with the goal of modifying disease and
improving quality of life. Leveraging genetics, biomarkers and
predictive sciences, we target key pathways involved in the
initiation and progression of neurological diseases to develop
therapies with the potential to optimize patient outcomes.
About Bristol Myers Squibb Bristol Myers Squibb is a
global biopharmaceutical company whose mission is to discover,
develop and deliver innovative medicines that help patients prevail
over serious diseases. For more information about Bristol Myers
Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter,
YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on current expectations and projections about our future
financial results, goals, plans and objectives and involve inherent
risks, assumptions and uncertainties, including internal or
external factors that could delay, divert or change any of them in
the next several years, that are difficult to predict, may be
beyond our control and could cause our future financial results,
goals, plans and objectives to differ materially from those
expressed in, or implied by, the statements. These risks,
assumptions, uncertainties and other factors include, among others,
that future study results may not be consistent with the results to
date, that KarXT (xanomeline-trospium) may not achieve its primary
study endpoints or receive regulatory approval for the indication
described in this release in the currently anticipated timeline or
at all, any marketing approvals, if granted, may have significant
limitations on their use, and, if approved, whether KarXT for such
indication described in this release will be commercially
successful. No forward-looking statement can be guaranteed.
Forward-looking statements in this press release should be
evaluated together with the many risks and uncertainties that
affect Bristol Myers Squibb’s business and market, particularly
those identified in the cautionary statement and risk factors
discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for
the year ended December 31, 2023, as updated by our subsequent
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and
other filings with the Securities and Exchange Commission. The
forward-looking statements included in this document are made only
as of the date of this document and except as otherwise required by
applicable law, Bristol Myers Squibb undertakes no obligation to
publicly update or revise any forward-looking statement, whether as
a result of new information, future events, changed circumstances
or otherwise.
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Bristol Myers Squibb (NYSE:BMY)
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