Bristol Myers Shares Phase 3 Results for Cobenfy in Schizophrenia Treatment
Bristol Myers Squibb (NYSE: BMY) has announced the topline results from the Phase 3 ARISE trial, assessing the efficacy and safety of Cobenfy™ (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with schizophrenia exhibiting inadequate symptom control.
Trial Overview
The ARISE trial was a 6-week, randomized, double-blind, placebo-controlled, multicenter study involving 386 adults aged 18 to 65 years. Participants were on stable background therapy with atypical antipsychotics and had a Positive and Negative Syndrome Scale (PANSS) score of ≥70 at screening. The primary endpoint was the change from baseline in PANSS total score at Week 6.
Efficacy Results
At Week 6, the Cobenfy plus atypical antipsychotic group demonstrated a least squares mean (LSM) change of -14.3 in PANSS total score, compared to -12.2 in the placebo plus atypical antipsychotic group, resulting in a nominal p-value of 0.11. This difference did not reach statistical significance for the primary endpoint.
In a post-hoc subgroup analysis, patients receiving risperidone as background therapy showed no significant difference in PANSS total score change when added to Cobenfy compared to placebo (LSM -11.3 vs. -12.3, p=0.66). Conversely, patients on non-risperidone antipsychotics (including paliperidone, aripiprazole, ziprasidone, lurasidone, and cariprazine) exhibited a significant improvement with Cobenfy (LSM -15.1 vs. -11.7, p=0.03).
Secondary and Exploratory Outcomes
Secondary endpoints, including the Personal and Social Performance (PSP) scale and Clinical Global Impressions-Severity (CGI-S) scale, did not show significant differences between treatment groups. Exploratory analyses indicated that Cobenfy may offer benefits in specific patient subgroups, warranting further investigation.
Safety and Tolerability
Cobenfy’s safety profile was consistent with previous studies. The most common treatment-emergent adverse events (TEAEs) in the Cobenfy group were nausea (19%), dyspepsia (18%), constipation (17%), vomiting (15%), and hypertension (11%). These events were generally mild to moderate in severity and did not lead to discontinuation in most cases.
Regulatory and Development Plans
Despite the primary endpoint not achieving statistical significance, Bristol Myers Squibb plans to complete a comprehensive analysis of the ARISE trial data. The company intends to engage with regulatory authorities and the medical community to discuss the findings and potential next steps for Cobenfy in the treatment of schizophrenia.
The ARISE trial is part of a broader clinical development program for Cobenfy, which includes studies in Alzheimer’s disease psychosis, bipolar disorder, and other neuropsychiatric conditions. The company remains committed to advancing research in these areas to address unmet medical needs.
About Cobenfy
Cobenfy is a first-in-class muscarinic agonist-antagonist combination therapy. Xanomeline, the muscarinic agonist, targets M1 and M4 receptors in the brain, while trospium chloride, the muscarinic antagonist, reduces peripheral cholinergic side effects. This unique mechanism of action differentiates Cobenfy from traditional antipsychotics that primarily target dopamine receptors.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. The company’s diverse portfolio includes treatments in oncology, immunology, cardiovascular disease, and neuroscience.
