US-based pharmaceutical company Bristol Myers Squibb (BMS) has reported topline outcomes from the Phase III ARISE trial of Cobenfy as an adjunctive treatment to atypical antipsychotics for schizophrenia.
The results show that the therapy failed to meet the threshold for statistical significance for the primary endpoint of change in the Positive and Negative Syndrome Scale (PANSS) total score.
The randomised six-week ARISE trial studied Cobenfy's effects in adult patients who do not have adequately controlled symptoms of schizophrenia and who had a PANSS score of 70 or more during screening and randomisation.
In it, the therapy showed a two-point reduction in total PANSS score at week six when used as an adjunctive treatment against a combination of placebo and an atypical antipsychotic.
Preliminary analyses of the ARISE trial indicate that the therapy could improve symptoms for certain subjects when used as an adjunctive treatment.
Following the trial, eligible subjects may join a 52-week open-label extension study for further assessment of the therapy’s long-term safety and tolerability.
BMS development head, chief medical officer and executive vice-president Samit Hirawat said: "Historically, the development of an effective, adjunctive treatment for schizophrenia has been difficult due to inherent challenges like variable patient response, stringent trial design requirements, and the complexities of demonstrating incremental benefits beyond established antipsychotics.
"While the primary endpoint in this trial did not meet statistical significance, we need to complete our analysis and will plan to engage with the medical community and regulators to discuss these results and potential next steps.”
Previously referred to as KarXT, Cobenfy is an oral therapy that is a combination of xanomeline and trospium chloride.
The drug is part of a wider clinical development programme targeting several neuropsychiatric conditions, including symptoms related to Alzheimer's disease, bipolar disorder and autism spectrum disorder.
