Long-term treatment with KarXT was associated with continued improvements in schizophrenia symptoms across all efficacy measures at 52 weeks
More than 75% of participants achieved a greater than 30% improvement in symptoms from baseline, as measured by the Positive and Negative Syndrome Scale (PANSS) total score, at one year
Participants previously taking placebo in acute studies experienced a significant reduction in symptoms starting in the second week and maintained throughout treatment
PRINCETON, NJ–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the EMERGENT-4 open-label Phase 3 extension study evaluating efficacy, safety and long-term tolerability term of KarXT (xanomelin -trospium) in adults with schizophrenia. The study’s long-term efficacy data were presented in a poster titled Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia (Poster F264) at the Schizophrenia International Research Society (SIRS) Annual Congress held 3-3 April 7. , 2024, in Florence, Italy.
We are pleased to see a significant, continuous and consistent reduction in schizophrenia symptoms over 52 weeks in an outpatient setting, beyond what was seen in the short-term, five-week inpatient studies (EMERGENT-2 and EMERGENT-3). , said Roland Chen, MD, senior vice president and head of development, immunology, cardiovascular and neuroscience, Bristol Myers (NYSE:) Squibb. We look forward to continuing conversations with the FDA and sharing additional data from the EMERGENT program later this year.
EMERGENT-4 is a 52-week, open-label, outpatient, Phase 3 extension study evaluating the long-term safety, tolerability, and efficacy of KarXT in adults with schizophrenia who have previously completed the of treatment in one of five Phase 3 studies. One-week, double-blind, placebo-controlled efficacy and safety studies, EMERGENT-2 or EMERGENT-3. At the time of the April 17, 2023 data cutoff, 110 patients were part of the interim efficacy analysis, including 29 patients who had completed 52 weeks of treatment.
In the interim analysis, KarXT was associated with significant improvement in schizophrenia symptoms across all efficacy measures at 52 weeks. At the end of the open-label extension, more than 75% of participants achieved the desired results >Symptom improvement of 30%, with an average reduction of 33.3 points compared to baseline (98.4), as measured by the Positive and Negative Syndrome Scale (PANSS) total score. Additionally, participants had an average change of 1.7 points in Clinical Global Impression-Severity (CGI-S) score from baseline (5.2), representing an average shift from “markedly ill” at baseline to “moderately ill” ” or “mildly” ill at baseline. one year.
The improvements in schizophrenia symptoms continued throughout the 52-week study, regardless of whether participants had previously been treated with KarXT or placebo during the acute studies. Prior to enrollment in the open-label extension, participants who had previously received placebo in the EMERGENT-2 and EMERGENT-3 studies had a significantly higher mean PANSS total score than those who had received KarXT (placebo 86.5 vs. KarXT 76 ,1). When treated with KarXT, patients previously treated with 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 studies.
This interim data from EMERGENT-4 continues to validate the potential of KarXT in the long-term management of schizophrenia, with continued benefit through 52 weeks of treatment, said Elan Cohen, Ph.D., principal investigator, CenExel Hassman Research Institute and research scientist in the EMERGING program. The consistency of efficacy results across EMERGENT clinical trial programs is encouraging and suggests that KarXT may provide a differentiated treatment approach for people living with schizophrenia.
In additional data presented at the conference, KarXT demonstrated a favorable impact on weight and long-term metabolic profile, with the majority of patients experiencing stability or improvements in metabolic parameters over 52 weeks of treatment. In long-term studies, KarXT was generally well tolerated, with a side effect profile consistent with previous studies of KarXT in schizophrenia. KarXT was not associated with significant prolactin-related changes or clinically significant changes in Movement Disorder Scale scores over 52 weeks (Oral Session: New Pharmacological Treatments and Evaluations and Poster F74).
About KarXT
KarXT (xanomelin-trospium) is an investigational muscarinic antipsychotic under development for the treatment of schizophrenia and Alzheimer’s disease-related psychosis. Through its novel mechanism of action, KarXT acts as a dual agonist at the M1/M4 muscarinic acetylcholine receptor in the central nervous system, which is believed 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.
Speaking of schizophrenia
Schizophrenia is a persistent and often disabling mental illness that affects how a person thinks, feels, and behaves and affects nearly 24 million people worldwide, including 2.8 million people in the United States. 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). Partly because of the limitations of current treatments, people with schizophrenia often have difficulty maintaining employment, living independently, and managing relationships. While current treatments may be effective in managing select symptoms, approximately 30% of people do not respond to therapy, with an additional 50% experiencing only partial improvement in symptoms or unacceptable side effects.
Bristol Myers Squibb: Delivering innovative science for meaningful interventions in neuroscience
Neurological conditions represent some of the greatest challenges of our time due to 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 disease-modifying and improving quality of life. By 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 BMS.com or follow us on LinkedIn, TwitterYouTube, Facebook (NASDAQ:) 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 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, deviate or change any of them in the foreseeable future. several years, which 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 or implied in the statements. Such risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with results to date, that KarXT (xanomelin-trospium) may not meet the study’s primary endpoints or receive Regulatory approval for the indication described. in this release in the currently anticipated timeframe or at all, any marketing approvals, if granted, may have significant limitations on their use and, if approved, whether KarXT for that indication described in this release will be commercially successful. No forward-looking statements can be guaranteed. Forward-looking statements in this press release should be evaluated in conjunction with the many risks and uncertainties affecting Bristol Myers Squibb’s business and markets, particularly those identified in the cautionary statement and discussion of risk factors in Bristol Myers’ annual report Squibb 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 herein are made only as of the date hereof and, except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information , future events, changed circumstances or otherwise.
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