Bristol Myers Squibb Shares Long-term Data on COBENFY™ for Schizophrenia at Psych Congress 2024

Bristol Myers Squibb has announced significant new findings from the Phase 3 EMERGENT-4 and EMERGENT-5 trials, which examined the long-term efficacy, safety, and tolerability of COBENFY™ (xanomeline and trospium chloride) for adults with schizophrenia. These results were shared at the 2024 Psych Congress held from October 29 to November 2 in Boston, Massachusetts.

Dr. Alyssa Johnsen, Senior Vice President and Head of Clinical Development for Immunology, Cardiovascular, and Neuroscience at Bristol Myers Squibb, highlighted the study's findings. She emphasized that COBENFY continues to show a favorable safety and tolerability profile, consistent with previous research. Notably, patients treated with COBENFY did not experience weight gain, movement disorders, or metabolic changes, which are common issues with many antipsychotic treatments. With COBENFY now available for use, the company anticipates further insights into its impact in real-world settings.

The EMERGENT-4 trial was a 52-week, open-label study involving 156 adults with schizophrenia who completed one of the earlier five-week, double-blind, placebo-controlled trials (EMERGENT-2 or EMERGENT-3). The trial demonstrated ongoing improvements in schizophrenia symptoms across all efficacy measures, including the Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity (CGI-S) score, and PANSS subscales. Those who had previously received a placebo showed rapid symptom improvement once they began taking COBENFY, and by four weeks, their PANSS scores were comparable to those who had been on COBENFY from the start. By the end of the trial, 69% of participants who completed the study achieved at least a 30% improvement in symptoms based on PANSS scores.

COBENFY was generally well tolerated in the long-term, with the most common treatment-emergent adverse events (TEAEs) being nausea, vomiting, dyspepsia, dry mouth, and hypertension. These events were mostly mild to moderate and did not lead to discontinuation of treatment. The discontinuation rate due to TEAEs was 11%. Additionally, COBENFY was associated with an average weight change of -1.9 kg over the 52 weeks and no significant changes in prolactin levels or movement disorder scores.

The EMERGENT-5 trial, also a 52-week, open-label study, included 566 U.S. adults with stable schizophrenia symptoms who had not previously been exposed to COBENFY. Participants had a mean PANSS score of 66.0 and a CGI-S score of 3.4, indicating mild to moderate illness. This trial further confirmed COBENFY's efficacy in maintaining symptom reduction long-term. By week 52, 30% of participants experienced at least a 30% reduction in PANSS total scores, with an average score reduction of -5.5 points from baseline.

In EMERGENT-5, COBENFY was well tolerated with similar common TEAEs, including nausea, vomiting, constipation, dry mouth, diarrhea, dyspepsia, dizziness, hypertension, and somnolence. Most events were mild or moderate, and the discontinuation rate due to TEAEs was 18%. The mean body weight change was -2.2 kg after 52 weeks, with no significant changes in movement disorder scales or prolactin levels.

Additionally, a qualitative survey conducted within the EMERGENT-5 trial assessed patient experiences and quality of life (QoL) improvements with COBENFY. Most participants reported QoL improvements in physical, social, emotional, and role functioning within six weeks of starting COBENFY. High levels of satisfaction with the treatment were maintained for up to six months, and 93% of participants stated they would recommend COBENFY to a friend or family member.

Schizophrenia is a chronic and often debilitating mental illness affecting how a person thinks, feels, and behaves. It presents with positive symptoms (like hallucinations and delusions), negative symptoms (such as lack of motivation and emotional expression), and cognitive dysfunction (including problems with attention and memory). Affecting nearly 24 million people globally, including 2.8 million in the U.S., schizophrenia ranks among the leading causes of disability worldwide.

COBENFY is an oral treatment combining xanomeline, a muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist. The efficacy of COBENFY is believed to stem from xanomeline's action on specific muscarinic receptors in the brain. COBENFY is indicated for treating schizophrenia in adults.