- The Phase 3 ARISE trial for Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) did not reach statistical significance for the primary endpoint.
- Cobenfy demonstrated a numerical improvement in symptoms of schizophrenia when used as an adjunctive treatment but did not achieve a statistically significant change in the PANSS total score.
- The company plans to complete further analyses and engage with regulators to discuss potential next steps for Cobenfy.
Bristol Myers Squibb (BMY, Financial) has announced the results of their Phase 3 ARISE trial which evaluated the efficacy of Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics in adults with schizophrenia. The study demonstrated a 2.0-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score for Cobenfy compared to placebo, which did not meet the threshold for statistical significance (P = 0.11).
Although the primary endpoint was not achieved, Cobenfy showed a numerical improvement in the PANSS total score when combined with an atypical antipsychotic, changing from -14.3 points compared to -12.2 points for the placebo group. Notably, a post-hoc analysis revealed better response rates for patients using Cobenfy in conjunction with non-risperidone antipsychotics.
Cobenfy maintained a safety and tolerability profile consistent with previous monotherapy trials. Bristol Myers Squibb intends to conduct further evaluations of the trial data and will present detailed findings at an upcoming medical conference. The company is also planning discussions with the medical community and regulators to determine future steps for Cobenfy's development.
Bristol Myers Squibb is developing Cobenfy for multiple neuropsychiatric conditions, including Alzheimer's disease, autism spectrum disorder, and bipolar disorder, among others. The ARISE trial represents an ongoing effort to explore complementary treatments that address persistent schizophrenia symptoms.
