Bristol Myers announces data from Phase 4 trial of Cobenfy

Bristol Myers (BMY) Squibb announced data from a Phase 4 clinical trial evaluating the symptom stability, safety and tolerability of Cobenfy 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. Data were presented at the 2026 Annual Congress of the Schizophrenia International Research Society, SIRS, taking place March 25-29 in Florence, Italy. 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, change from baseline to week 8 in the PANSS total score, CGI-S, Personal and Social Performance, and Medication Satisfaction Questionnaire. In the trial, approximately 86% of patients completed 8 weeks of treatment, with discontinuation rates of 15.1% and 13.5% 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.