Bristol Myers Squibb Presents New Interim Long-Term Efficacy Data from the EMERGENT-4 Trial Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society
- More than 75% of participants achieved >30% improvement in symptoms from baseline
- KarXT showed significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks
- Patients previously on placebo in acute trials experienced significant reduction of symptoms beginning at week two
- KarXT demonstrated favorable impact on weight and long-term metabolic profile over 52 weeks
- KarXT was generally well tolerated with a side effect profile consistent with prior trials
- None.
The interim results from the Phase 3 EMERGENT-4 trial for KarXT bring promising news for the treatment of schizophrenia, a chronic mental health disorder. The data indicating that over 75% of participants achieved more than 30% improvement in their symptoms as measured by the PANSS total score is a significant clinical milestone. This is particularly noteworthy as the PANSS is a widely recognized tool for measuring the severity and improvement of schizophrenia symptoms, including positive symptoms like hallucinations and delusions, negative symptoms such as lack of emotion and general psychopathology.
The continuation of symptom improvement over a 52-week period suggests that KarXT could offer a sustainable long-term benefit, which is a critical factor in the management of schizophrenia, as many antipsychotics lose efficacy or are not tolerated over longer periods. The observed stability or improvements in metabolic parameters are also key, given the well-documented metabolic side effects associated with many antipsychotic drugs, which can lead to additional health complications like diabetes and heart disease. The favorable metabolic profile of KarXT could thus position it as a preferable option for long-term management, potentially influencing prescribing practices and market share within the antipsychotic drug segment.
The economic implications of the EMERGENT-4 trial results for KarXT are multifaceted. For healthcare systems, the prospect of a new treatment that is both efficacious and well-tolerated over the long term could mean fewer hospitalizations, reduced need for adjunctive therapies and potentially lower overall treatment costs for schizophrenia. A treatment that does not exacerbate metabolic issues could also decrease the long-term burden on healthcare resources by mitigating the risk of secondary conditions that are costly to treat.
From a payer perspective, a medication that improves patient outcomes while reducing the incidence of side effects could lead to shifts in formulary placements and insurance coverage decisions. This could enhance market access for KarXT and increase its adoption. However, the cost of the drug, the reimbursement landscape and the competitive market dynamics will ultimately influence its economic impact. The long-term data could also be leveraged in value-based contracting, where reimbursement is tied to patient outcomes, offering an innovative approach to pricing and reimbursement negotiations.
The announcement regarding KarXT's performance in the EMERGENT-4 trial is likely to have a positive impact on the market perception of Bristol Myers Squibb, potentially influencing investor confidence and stock valuation. The clinical success of KarXT in a long-term study not only strengthens the product's profile but also enhances the company's reputation in the neuroscience field. The market for antipsychotic drugs is competitive and a new entrant that demonstrates sustained efficacy and safety over a year-long period could disrupt the current market dynamics.
Investors will be particularly interested in the potential market size for KarXT, the scalability of its production and the strategic plans for its commercialization. Additionally, the anticipation of further conversations with the FDA suggests a trajectory towards potential approval, which is a critical milestone for any pharmaceutical product. The stock market often reacts positively to such progressive clinical developments, especially when they address a substantial unmet medical need, as is the case with long-term management of schizophrenia.
Long-term treatment with KarXT was associated with continued improvements in symptoms of schizophrenia across all efficacy measures at 52 weeks
More than
Participants previously on placebo in acute trials experienced significant reduction of symptoms beginning at week two and maintained throughout treatment
“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
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
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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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