Bristol Myers Squibb (BMS) has delayed the data readout from the Phase III ADEPT-2 trial of Cobenfy (xanomeline/trospium chloride) after identifying site irregularities.
The trial (NCT06126224) is investigating Cobenfy in patients suffering from psychosis associated with Alzheimer’s disease.
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BMS said it is enrolling additional patients after excluding certain patient data from the interim analysis following irregularities in clinical trial execution at a few study sites.
After informing the US Food and Drug Administration (FDA) of the site issue, an independent data monitoring committee (DMC) evaluated the data. The DMC recommended that the study should continue and that more patients should be enrolled into the trial.
The data was originally expected by the end of this year; however, BMS has now provided an end of 2026 estimate due to the additional enrolment.
Dr Laura Gault, MD, head of development in neuroscience at BMS, said: “BMS agrees with the decision made in consultation with the FDA and DMC to continue the Phase III study and will move forward with recruiting additional patients.
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By GlobalData“Our decision to exclude patient data from sites where irregularities were observed reflects our unwavering commitment to safeguarding the integrity of our studies. Psychosis related to Alzheimer’s disease remains an area of tremendous unmet medical need, and maintaining rigorous standards is essential as we work to identify innovative treatment options for patients and families affected by this devastating condition.”
The drug is being investigated in three other studies looking at its impact on patients with psychosis associated with Alzheimer’s disease. It is also being investigated in bipolar disorder, with a Phase III trial planned to read out in 2027.
BMS acquired Cobenfy during a $14bn buyout of Karuna Therapeutics in 2023. The drug gained FDA approval for the treatment of schizophrenia in September 2024. Despite this, the drug failed a Phase III study in schizophrenia in conjunction with other drugs earlier this year.
GlobalData’s patient-based forecast predicts that the drug will achieve blockbuster status in 2027, with 2031 sales set to reach $2.36bn.
GlobalData is the parent company of Clinical Trials Arena.
