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 (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia. Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.

“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 75% of participants achieved >30% improvement in symptoms, with an average reduction of 33.3-points from baseline (98.4), as measured by the Positive and Negative Syndrome Scale (PANSS) total score. In addition, participants had a mean 1.7-point change in Clinical Global Impression-Severity (CGI-S) score from baseline (5.2), representing an average shift from ‘markedly ill’ at baseline to ‘moderately’ or ‘mildly’ ill at one year.