Bristol Myers Squibb Data from Phase 4 Cobenfy Trial

 

Open Label Outpatient Switch Study Demonstrates Symptom Stability During Transition from Oral Atypical Antipsychotics to Cobenfy

High treatment completion and no discontinuations due to lack of efficacy observed across faster and slower switch strategies

 Bristol Myers Squibb (NYSE: BMY) today announced data from a Phase 4 clinical trial evaluating the symptom stability, safety and tolerability of Cobenfy (xanomeline and trospium chloride) when switching adult outpatients with schizophrenia from an oral atypical antipsychotic to Cobenfy monotherapy. Through 8 weeks, patients remained stable with mean Positive and Negative Syndrome Scale (PANSS) total scores remaining below baseline, and no new safety signals were observed, regardless of cross-titration duration. These findings provide important evidence to help inform treatment switch strategies in clinical practice. Data were presented at the 2026 Annual Congress of the Schizophrenia International Research Society (SIRS) taking place March 25-29 in Florence, Italy.

“While transitioning patients is common in schizophrenia, clinicians have historically had limited data to help guide these decisions, especially for differentiated treatments like Cobenfy,” said David Walling, PhD, principal investigator and chief clinical officer at Cenexel – CNS. “The data presented today provide much-needed insight into what happens during a switch to Cobenfy, notably that patients remained stable through 8 weeks of treatment regardless of a slower or faster cross-titration, which will help healthcare professionals make informed treatment decisions for adults living with schizophrenia.”

This 8-week, open-label trial evaluated two cross-titration strategies in adults with schizophrenia (n=105): tapering the existing atypical antipsychotic down over the faster 2 week (n=52) or slower 4 week (n=53) period while simultaneously up-titrating Cobenfy to the target dose of 125/30 mg BID, over two weeks in both arms. Patients were required to have a PANSS total score at or below 80 at screening and baseline, Clinical Global Impression-Severity (CGI-S) score of ≤4, and to be on a stable dose of an oral atypical antipsychotic for at least 6 weeks.

The primary objective of the trial was to evaluate the rate of all-cause Cobenfy discontinuation over a period of 8 weeks. Key secondary endpoints included Cobenfy discontinuation due to a lack of efficacy, incidence of, and discontinuations due to adverse events (AEs), change from baseline (CFB) to week 8 in the PANSS total score, CGI-S, Personal and Social Performance (PSP), and Medication Satisfaction Questionnaire (MSQ).

In the trial, approximately 86% of patients completed 8 weeks of treatment, with discontinuation rates of 15.1% (n=8) and 13.5% (n=7) in the slower and faster transition groups. No patients discontinued treatment with Cobenfy due to lack of efficacy. Mean changes in PANSS total scores from baseline to week 8 were −4.2 in the slower transition group and −3.1 in the faster transition group. Mean change in CGI-S scores was −0.2 in both the slower and faster transition groups. From baseline to week 8, mean PSP scores improved by 1.1 and 0.7 in the slower and faster transition groups, respectively.

https://investors.bms.com/iframes/press-releases/press-release-details/2026/Open-Label-Outpatient-Switch-Study-Demonstrates-Symptom-Stability-During-Transition-from-Oral-Atypical-Antipsychotics-to-Cobenfy-xanomeline-and-trospium-chloride/default.aspx