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Investing.com -- Shares of Bristol Myers Squibb (NYSE: NYSE:BMY) fell 7% after hours as the company reported topline results from its Phase 3 ARISE trial, which did not meet the primary endpoint for statistical significance. The trial evaluated Cobenfy, an adjunctive treatment to atypical antipsychotics in adults with schizophrenia, and found a 2.0-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 6, with a p-value of 0.11.
Despite the trial’s outcome, the company noted that treatment with Cobenfy and an atypical antipsychotic showed a numerical improvement compared to treatment with a placebo and an atypical antipsychotic. Furthermore, Cobenfy’s safety and tolerability profile as an adjunctive therapy was consistent with previous monotherapy trials.
The ARISE trial’s results were mixed, with a post-hoc subgroup analysis revealing a notable difference in response between subjects treated with risperidone as a background therapy compared with those treated with other background antipsychotics. In this subgroup, Cobenfy showed a statistically significant improvement in PANSS total score with a p-value of 0.03.
Bristol Myers Squibb plans to conduct further analysis and engage with the medical community and regulators to discuss potential next steps. The company emphasized the complexity of developing effective adjunctive treatments for schizophrenia due to variable patient responses and the difficulties in demonstrating incremental benefits beyond established antipsychotics.
The clinical development program for Cobenfy continues, with ongoing research across multiple neuropsychiatric conditions, including Alzheimer’s disease, autism spectrum disorder, bipolar disorder, and other areas of significant clinical need. Detailed results from the Phase 3 trial are expected to be presented at an upcoming medical conference, and the company extends its gratitude to the patients, investigators, and clinical trial sites involved in the ARISE trial.
The ARISE trial is a part of a comprehensive clinical program exploring the long-term safety and efficacy of Cobenfy as an adjunctive treatment in schizophrenia, with a 52-week open-label extension study to follow. Bristol Myers Squibb remains committed to addressing the unmet needs in neuropsychiatric conditions and advancing the development of potential treatments.