A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia.
Bristol Myers Squibb announced results from its Phase III EMERGENT-4 trial analyzing the long-term efficacy, safety, and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia, which was showcased at the Annual Congress of the Schizophrenia International Research Society (SIRS). Additionally, the company revealed promising pooled data from EMERGENT-4 and EMERGENT-5 for the long-term safety, tolerability, and metabolic effects of KarXT in schizophrenia over 52 weeks.
EMERGENT-4 is a 52-week, open-label extension trial assessing long-term efficacy, safety, and tolerability of KarXT in adults who completed earlier phases of the trial for schizophrenia. Investigators found that over 75% of patients administered KarXT achieved a 30% improvement in symptoms.1
“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, SVP, head, immunology, cardiovascular and neuroscience development, Bristol Myers Squibb, in a press release. “We look forward to continued conversations with the FDA and to sharing additional data from the EMERGENT program later this year.”
According to the pooled data from EMERGENT-4 and EMERGENT-5, 65% of patients experienced significant weight reduction, although no major changes were found in total cholesterol, triglycerides, and HbA1c levels. Further, KarXT was found to be well-tolerated with minor adverse effects (AEs). However, 53% of the study’s patients discontinued participation as a result of withdrawn consent and treatment-related AEs. Common AEs included nausea, vomiting, constipation, dry mouth, dyspepsia, dizziness, hypertension, and diarrhea. Further, 62% of patients reported experiencing at least one of these symptoms.2
“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, MD, chief scientific officer, medical director, Segal Trials, investigator in the EMERGENT program, in a press release. “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.”
According to the World Health Organization (WHO), people with schizophrenia are more likely to die at an earlier age than the overall population, as a result of multiple physical illnesses. They also struggle with cognitive or thinking skills.3
“Schizophrenia affects approximately 24 million people or 1 in 300 people (0.32%) worldwide,” reports WHO. “This rate is 1 in 222 people (0.45%) among adults (2). It is not as common as many other mental disorders. Onset is most often during late adolescence and the twenties, and onset tends to happen earlier among men than among women.”
References
1. 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. Bristol Myers Squibb. April 6, 2024. Accessed April 9, 2024. https://news.bms.com/news/corporate-financial/2024/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/default.aspx
2. 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. Bristol Myers Squibb. April 6, 2024. Accessed April 9, 2024. https://news.bms.com/news/corporate-financial/2024/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/default.aspx
3. Schizophrenia. WHO. January 10, 2022. Accessed April 9, 2024. https://www.who.int/news-room/fact-sheets/detail/schizophrenia
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Cell and Gene Therapy Check-in 2024
January 18th 2024Fran Gregory, VP of Emerging Therapies, Cardinal Health discusses her career, how both CAR-T therapies and personalization have been gaining momentum and what kind of progress we expect to see from them, some of the biggest hurdles facing their section of the industry, the importance of patient advocacy and so much more.
ROI and Rare Disease: Retooling the ‘Gene’ Value Machine
November 14th 2024Framework proposes three strategies designed to address the unique challenges of personalized and genetic therapies for rare diseases—and increase the probability of economic success for a new wave of potential curative treatments for these conditions.
Tirzepatide Demonstrates Significant Benefits for Patients with Pre-Diabetes, Obesity Over 176 Weeks
November 14th 2024Results from the Phase III SURMOUNT-1 study show that tirzepatide, a dual GIP and GLP-1 receptor agonist, achieved substantial average weight loss of 22.9% in patients with pre-diabetes and obesity.