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

Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, taking place May 28-31, 2024 in Miami, FL.

“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 Alyssa Johnsen, MD, PhD, senior vice president and head of clinical development, Immunology, Cardiovascular and Neuroscience, Bristol Myers Squibb. “The impact of KarXT for patients and their care partners is promising, and we look forward to continuing our conversations with the U.S. Food & Drug Administration this year.”

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 Author

Type/#

Session Title

Time (ET)

Wednesday, May 29, 2024

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 Session I

11:15 AM – 1:15 PM

Characterizing the Safety Profile of KarXT Relative to Anticipated D2-Dopamine-based Antipsychotic Medications in FAERS

Ramsay, I.

Poster W52

Low Long-Term Risk of EPS with Muscarinic Agonist KarXT (Xanomeline and Trospium)

Novak, K.

Poster W86

Thursday, May 30, 2024

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 Session II

12:30 PM - 2:15 PM

Responses to KarXT in Short-Term Placebo-Controlled Trials in Schizophrenia

Ramsay, I.

Poster T76

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 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 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 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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