Bristol Myers Squibb recently unveiled positive topline results from two Phase 3 open-label trials, EMERGENT-4 and EMERGENT-5. These trials assessed the long-term efficacy, safety, and tolerability of COBENFY (xanomeline and trospium chloride) in adults with schizophrenia over a 52-week treatment period. The data were presented at the 2024 Psych Congress in Boston.
EMERGENT-4, a 52-week open-label extension study, involved 156 adults with schizophrenia who had completed either the EMERGENT-2 or EMERGENT-3 trial. COBENFY demonstrated sustained improvement in schizophrenia symptoms across various measures, including the Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity (CGI-S) score, and PANSS positive and negative subscale scores. Notably, participants who initially received placebo in the earlier trials experienced rapid symptom improvement upon starting COBENFY. By the study’s conclusion, 69% of participants achieved a 30% or greater improvement in PANSS total score from their initial baseline. COBENFY’s long-term use was generally well-tolerated, with no new safety or tolerability concerns identified. The most frequent treatment-emergent adverse events (TEAEs) included nausea, vomiting, dyspepsia, dry mouth, and hypertension, which were typically mild to moderate and resolved without requiring treatment discontinuation. The overall discontinuation rate due to TEAEs was 11%. Furthermore, COBENFY did not show clinically significant changes in body weight, prolactin levels, or movement disorder scale scores.
The EMERGENT-5 trial, also a 52-week open-label study, evaluated COBENFY in 566 adults with schizophrenia in the U.S. These participants had stable symptoms on a previous antipsychotic and no prior COBENFY exposure. The trial included individuals with mild to moderate illness based on PANSS and CGI-S scores. COBENFY demonstrated improvements across all efficacy measures, including PANSS total, CGI-S, and PANSS subscale scores, confirming its sustained effectiveness. By week 52, 30% of participants achieved a 30% or greater reduction in PANSS total score from baseline. Long-term COBENFY treatment was generally well-tolerated in this trial as well, with no new safety or tolerability issues arising. The most frequent TEAEs were similar to those observed in EMERGENT-4, mostly mild to moderate in intensity, and did not generally lead to treatment discontinuation. The discontinuation rate due to TEAEs in EMERGENT-5 was 18%. Similar to EMERGENT-4, COBENFY was not associated with significant changes in body weight, movement disorder scales, or prolactin levels.
A qualitative interview-based survey was conducted within the EMERGENT-5 trial to assess patient-reported experiences and perceived changes in Quality of Life (QoL) with COBENFY treatment. Interviews were conducted at six weeks and six months after starting COBENFY. At baseline, most participants reported negative QoL impacts across physical, social, emotional, and role functioning domains. A significant majority reported improvements in at least one QoL domain within six weeks of starting COBENFY, with high satisfaction levels maintained through six months. Participants attributed their satisfaction to perceived symptom improvement, enhanced QoL, and minimal treatment burden. A vast majority of participants at the six-month mark indicated they would recommend COBENFY and would choose to continue treatment if given the opportunity.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
