KarXT demonstrated a favorable
long-term metabolic profile where most patients experienced
stability or improvements on metabolic parameters over 52 weeks of
treatment
A majority of patients (65%) experienced
reductions in weight over the course of the trial, with a mean
weight decrease of 2.6kg observed at one year
Data show no significant changes related to
prolactin or clinically meaningful changes in movement disorder
scale scores over 52 weeks
KarXT was generally well tolerated, with a
side effect profile consistent with prior trials of KarXT in
schizophrenia
Bristol Myers Squibb (NYSE: BMY) today announced interim
long-term safety, tolerability and metabolic outcomes data from its
Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in
adults with schizophrenia. These data were presented in a poster
titled, “Long-Term Safety of KarXT (Xanomeline and Trospium) in
Schizophrenia” (Poster F74) and in the Oral Session “Long-Term
Metabolic Outcomes Associated With KarXT (Xanomeline and Trospium):
Interim Results From Pooled, Long-Term Safety Studies EMERGENT-4
and EMERGENT-5” at the Annual Congress of the Schizophrenia
International Research Society (SIRS) being held April 3-7, 2024,
in Florence, Italy.
“These long-term safety results and metabolic outcomes from the
EMERGENT program are extremely encouraging, allowing us to further
understand the tolerability profile of KarXT in people living with
schizophrenia,” said Roland Chen, MD, senior vice president and
head, Immunology, Cardiovascular and Neuroscience development,
Bristol Myers Squibb. “It is promising to see that over one year of
treatment, KarXT was not associated with burdensome side effects,
specifically weight gain and metabolic dysfunction, as well as
extrapyramidal symptoms, which underscores its potential to provide
a meaningful and differentiated option for people living with
schizophrenia.”
Pooled Interim Long-Term Metabolic Outcomes Associated with
KarXT (EMERGENT-4 and EMERGENT-5)
The EMERGENT-4 and EMERGENT-5 trials are Phase 3, outpatient,
52-week, open-label trials evaluating the safety, tolerability, and
efficacy of KarXT in adults with schizophrenia. At the time of the
data cutoff of August 18, 2023, the interim pooled data analysis
included 718 patients who received at least one dose of KarXT, with
134 patients having completed one year of treatment.
In the pooled analysis, KarXT demonstrated a favorable impact on
weight and long-term metabolic profile where most patients
experienced stability or improvements on key metabolic parameters
over 52 weeks of treatment. The majority of patients (65%)
experienced an overall reduction in weight over the course of the
trial, with more patients (18%) experiencing potentially clinically
significant (≥7% change) decreases in weight vs. 4% of patients
experiencing increases in weight (≥7% change). In patients who
completed 52 weeks of treatment with KarXT, an average reduction in
weight of 2.6kg was observed, with a larger mean reduction in
weight of 4.1kg observed in clinically obese patients (BMI
> 30 kg/m2). Total cholesterol,
triglyceride and HbA1c levels did not meaningfully change over one
year of treatment.
Interim Long-Term Pooled Safety Outcomes Associated with
KarXT (EMERGENT-4 and EMERGENT-5)
In the long-term studies, KarXT was generally well-tolerated
across 52 weeks of treatment, with a side effect profile consistent
with prior trials of KarXT in schizophrenia. The overall
discontinuation rate in the trial was 53% and primary reasons for
discontinuation included withdrawn consent (19%), treatment-related
adverse events (15%), participant lost to follow-up (8%), and
participant failed to adhere to protocol requirements (7%).
Across the long-term EMERGENT trials, 62% of participants
reported at least one treatment-related adverse event. The most
common treatment-related adverse events (≥5%) were nausea,
vomiting, constipation, dry mouth, dyspepsia, dizziness,
hypertension, and diarrhea, of which nearly all were mild or
moderate in severity and transient in nature.
KarXT was not associated with significant changes related to
prolactin or clinically meaningful changes in movement disorder
scale scores over 52 weeks.
“People living with schizophrenia and their care partners have
long carried the burden of the condition, with a lack of treatment
options that adequately treat the symptoms of schizophrenia without
common debilitating side effects. To see that the long-term
tolerability profile of KarXT remains consistent with earlier
studies, where the cholinergic side effects of KarXT remained
mainly mild or moderate in severity, and were transient and
resolving with continued treatment is very encouraging,” said Rishi
Kakar, M.D., chief scientific officer and medical director of Segal
Trials and investigator in the EMERGENT program. “These results are
extremely promising and add to the growing body of data which
suggest that, if approved, KarXT could provide a long-desired,
differentiated treatment option for people living with
schizophrenia.”
In additional interim long-term data presented at the congress,
KarXT was associated with significant improvements in symptoms of
schizophrenia across all efficacy measures at 52 weeks in the
EMERGENT-4 trial. Improvements in symptoms of schizophrenia
continued throughout the open-label extension regardless of whether
participants were previously treated with KarXT or placebo during
the acute trials, EMERGENT-2 or EMERGENT-3 (Poster F264).
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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