Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society
- KarXT demonstrated positive long-term metabolic outcomes with most patients experiencing weight reductions and stability over 52 weeks of treatment.
- The interim data showed a mean weight decrease of 2.6kg in patients after one year of treatment with KarXT.
- No significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores were observed over 52 weeks.
- KarXT was generally well tolerated with a side effect profile consistent with prior trials in schizophrenia.
- The trials included 718 patients with 134 completing one year of treatment, showing promising results for KarXT in schizophrenia treatment.
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The interim results from the Phase 3 EMERGENT program for KarXT present a significant advancement in the treatment of schizophrenia, particularly focusing on the metabolic effects and safety profile of the drug over a one-year period. The data indicating most patients experienced stability or improvements in metabolic parameters and a majority saw weight reductions, is a notable deviation from the typical antipsychotic medication profile, which often leads to weight gain and metabolic issues.
From a medical research perspective, the implications of these findings are multifaceted. For patients, the potential for a treatment option that does not exacerbate metabolic disorders is a considerable benefit, potentially improving adherence to medication and overall quality of life. For healthcare providers, it offers an alternative that may reduce the burden of managing the side effects associated with conventional antipsychotics. Moreover, this could lead to a shift in prescribing patterns if KarXT is approved, as its safety profile might be preferred over existing treatments.
For Bristol Myers Squibb, these positive results could translate into a competitive advantage in the antipsychotic drug market. The ability to offer a medication that mitigates common side effects could drive market share growth and bolster the company's revenue stream, assuming the drug receives regulatory approval and is well-received by the medical community.
The economic implications of the long-term use of KarXT, as per the EMERGENT program data, could be substantial for the healthcare system. The reduction in weight and the absence of significant metabolic side effects could translate into lower long-term healthcare costs associated with the management of weight-related comorbidities and metabolic disorders, which are common in patients treated with other antipsychotic drugs.
Moreover, the potential decrease in discontinuation rates due to adverse side effects, as suggested by the tolerability of KarXT, might lead to improved treatment outcomes and reduced hospitalization rates. These factors combined could offer substantial cost savings for both payers and patients and might influence reimbursement decisions and the positioning of KarXT within treatment guidelines.
It is also important to consider the broader economic impact, including the potential for increased productivity and reduced disability claims if patients experience fewer side effects and better manage their schizophrenia. This could have positive ripple effects on the economy, with patients potentially maintaining more consistent employment and requiring less social support.
The announcement of the interim long-term safety and metabolic outcomes data from Bristol Myers Squibb's Phase 3 EMERGENT program is likely to be closely watched by investors and market analysts. The results showing a favorable metabolic profile and weight reduction in patients treated with KarXT could position the drug as a strong contender in the antipsychotic market, which is valued at several billion dollars globally.
Given the chronic nature of schizophrenia and the size of the patient population, a drug that offers a better side effect profile could capture significant market share. The data presented could lead to a reassessment of Bristol Myers Squibb's stock valuation by analysts, potentially factoring in the future revenue streams from KarXT, should it gain regulatory approval.
Investors will be interested in the potential for KarXT to become a blockbuster drug, which is typically defined as a drug generating more than $1 billion in annual sales. The market's response to these interim results could be reflected in the short-term stock price movement of Bristol Myers Squibb, with long-term value being contingent upon successful commercialization and market adoption of KarXT.
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 (
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
“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 (
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
Across the long-term EMERGENT trials,
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
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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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