Bristol Myers Squibb to Present Data at the 2024 American Society of Clinical Psychopharmacology Annual Meeting
Consistent with short-term studies, KarXT was not associated with clinically meaningful changes in movement disorder scale scores and a low incidence rate of extrapyramidal symptoms was reported over long-term trials in adults with schizophrenia
In-trial qualitative interviews found that the majority of participants treated with KarXT in the long-term EMERGENT-5 trial perceived improvements in positive, negative and cognitive symptoms of schizophrenia
“The presentation of additional data from the EMERGENT program continues to illustrate the potential of KarXT as a novel treatment for schizophrenia, with its differentiated mechanism of action and safety and efficacy profile,” said
Research to be presented at the meeting continues to demonstrate the potential of KarXT as a differentiated treatment option for adults living with schizophrenia. Notable data poster presentations include:
Low Long-Term Risk of Extrapyramidal Symptoms (EPS) with Muscarinic Agonist KarXT (Xanomeline and Trospium) (W86)
- Among pooled interim data from the Phase 3 outpatient, 52-week, open-label EMERGENT-4 and EMERGENT-5 studies, the incidence of extrapyramidal symptoms (EPS) adverse events (AEs) deemed to be treatment-related was 1% and the most commonly reported treatment-related EPS AE was akathisia (0.6%). KarXT was not associated with clinically meaningful changes from baseline in movement disorder scale scores on the Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS) over short or long-term studies.
Assessing Participant Experience with KarXT Treatment Using In-Trial Qualitative Interviews: Initial Findings from a Long-Term Phase 3 Trial in Schizophrenia (W24)
- In the Phase 3 outpatient, 52-week, open-label EMERGENT-5 trial evaluating the safety, tolerability and efficacy of KarXT in adults with schizophrenia, in-trial interviews were conducted with participants to provide qualitative insights to characterize their experience during the trial to better understand changes in symptoms and define meaningful treatment. Initial findings showed participants perceived an improvement in positive, negative, and cognitive symptoms of schizophrenia since initiating KarXT.
Complete abstracts may be accessed online here, and a full overview of abstracts to be presented at ASCP by BMS can be found below.
Abstract Title |
Primary
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Type/# |
Session
|
Time (ET) |
|
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Assessing Participant Experience with KarXT Treatment Using In-Trial Qualitative Interviews: Initial Findings from a Long-Term Phase 3 Trial in Schizophrenia |
Horan, W. |
Poster W24 |
Poster
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Characterizing the Safety Profile of KarXT Relative to Anticipated D2-Dopamine-based Antipsychotic Medications in FAERS |
Ramsay, I. |
Poster W52 |
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Low Long-Term Risk of EPS with Muscarinic Agonist KarXT (Xanomeline and Trospium) |
Novak, K. |
Poster W86 |
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KarXT (Xanomeline and Trospium) for the Treatment of Schizophrenia: Number Needed to Treat, Number Needed to Harm, and likelihood to Be Helped or Harmed |
Citrome, L. |
Poster T58 |
Poster
|
|
Responses to KarXT in Short-Term Placebo-Controlled Trials in Schizophrenia |
Ramsay, I. |
Poster T76 |
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Measurement of Positive and Negative Symptoms Through Speech Analysis from PANSS Interview Recordings in Patients with Schizophrenia |
Abbas, A. |
Poster T78 |
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
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
About
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 may not 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
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