Bristol Myers presents new long-term data from EMERGENT study of COBENFY

Bristol Myers (BMY) Squibb “announced new topline results from the Phase 3 EMERGENT-4 and EMERGENT-5 open-label trials evaluating the long-term efficacy, safety, and tolerability of COBENFY in adults with schizophrenia over 52 weeks of treatment. Data were presented at the 2024 Psych Congress, taking place from October 29 – November 2, 2024 in Boston, MA. EMERGENT-4 was a Phase 3, 52-week, outpatient, open-label extension study evaluating the long-term safety, tolerability, and efficacy of COBENFY in 156 adults with schizophrenia who previously completed the treatment period of one of the Phase 3, five-week, double-blind, placebo-controlled, efficacy and safety studies, EMERGENT-2 or EMERGENT-3. In the trial, treatment with COBENFY led to continued improvements in symptoms of schizophrenia across all efficacy measures, including the Positive and Negative Syndrome Scale total, Clinical Global Impression-Severity, PANSS positive subscale, and PANSS negative subscale scores, over 52 weeks. Participants who received placebo in the acute trials demonstrated rapid improvement in symptoms once COBENFY was initiated. At four weeks, PANSS total scores were comparable between those who previously received COBENFY or placebo in the acute trials. Improvements in symptoms of schizophrenia continued throughout the 52-week study regardless of whether participants received COBENFY or placebo in the acute trials. At the end of the trial, 69% of participants who completed the study achieved greater than or equal to30% improvement in schizophrenia symptoms from acute trial baseline, as measured by the PANSS total score. Long-term treatment with COBENFY was generally well-tolerated, with no new safety or tolerability issues identified from prior trials of COBENFY. The most common treatment-related treatment-emergent adverse events, or TEAEs, (greater than or equal to5%) were nausea, vomiting, dyspepsia, dry mouth, and hypertension. The majority were mild to moderate in intensity, did not lead to discontinuation of COBENFY, and resolved with continued treatment. The discontinuation rate due to TEAEs in EMERGENT-4 was 11%. COBENFY was associated with a mean change in body weight of -1.9 kg (+/-4.7 kg) when measured from the acute trial baseline at 52 weeks. Additionally, COBENFY was not associated with clinically meaningful changes in mean prolactin levels or on movement disorder scale scores over 52 weeks. There were no reported TEAEs of akathisia or tardive dyskinesia.”