BMS postpones release of Alzheimer's study results for Cobenfy due to "site irregularities"

Bristol Myers Squibb (BMS) has postponed the release of data from the Phase III ADEPT-2 study of Cobenfy (xanomeline/trospium chloride) after detecting irregularities at certain trial sites. The study (NCT06126224) is evaluating the drug in patients experiencing psychosis linked to Alzheimers disease.

Following the discovery of these inconsistencies, BMS excluded affected patient data from the interim analysis and decided to recruit additional participants. The US Food and Drug Administration (FDA) was notified, and an independent data monitoring committee (DMC) reviewed the findings. The DMC advised continuing the study with expanded enrollment.

Data that was initially expected by the end of this year is now projected for late 2026 due to the extra patient recruitment. Dr. Laura Gault, MD, head of neuroscience development at BMS, emphasized that the companys approach ensures study integrity and reflects its commitment to high standards in addressing psychosis related to Alzheimers disease.

Cobenfy is also being studied in three other trials focusing on Alzheimers-related psychosis and is being evaluated for bipolar disorder, with a Phase III study expected to report results in 2027. BMS acquired the drug in 2023 through a $14 billion acquisition of Karuna Therapeutics. Cobenfy received FDA approval for schizophrenia treatment in September 2024, although it previously failed a Phase III trial in combination with other medications.

Market projections from GlobalData anticipate that Cobenfy will reach blockbuster status by 2027, with estimated sales of $2.36 billion by 2031.

Author: Gavin Porter