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Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee
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BMS Remains Blinded to Study Data
December 03, 2025--PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY, “BMS”) today announced that it will enroll additional patients in the ADEPT-2 study. As part of its commitment to upholding the highest standards in clinical research and following a thorough blinded review of the ADEPT-2 study data, the company identified irregularities due to clinical trial execution at a small number of study sites. With these findings, prior to database lock, BMS made the decision to exclude patient data from those sites from the primary analysis. Following consultation and agreement with the U.S. Food and Drug Administration (FDA), an interim data analysis for efficacy and safety was conducted by an independent party and reviewed by the Data Monitoring Committee (DMC).
Following this analysis, the DMC recommended the study continue by enrolling additional patients to the original target study population. Based on this recommendation, BMS will continue patient enrollment and advance the program as advised by the DMC. BMS remains blinded to study data.
“BMS agrees with the decision made in consultation with the FDA and DMC to continue the Phase 3 study and will move forward with recruiting additional patients,” said Laura Gault, MD, PhD, Senior Vice President, Head of Development, Neuroscience Drug Development, Bristol Myers Squibb. “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.”
Cobenfy, currently approved for the treatment of schizophrenia in adults, has the potential to be the first treatment in a new class of pharmacologic therapies targeting agitation and psychosis based on muscarinic receptor agonism. Additional trial results from the ADEPT program in psychosis associated with Alzheimer's Disease, including ADEPT-2, ADEPT-1 and ADEPT-4, are expected to read out by the end of 2026.
BMS is taking a holistic approach to developing novel approaches to treat Alzheimer’s Disease, dually pursuing investigational therapies that aim to both meaningfully slow disease progression and to ease symptoms to help give patients, families and caregivers back some of what the disease has taken away.
About ADEPT-2
The ADEPT-2 study (clinicaltrials.gov, NCT06126224) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of Cobenfy in subjects with psychosis associated with Alzheimer’s disease dementia. The study is designed to evaluate the primary endpoint of changes in the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score and the key secondary endpoint of Clinical Global Impression-Severity (CGI-S), with additional assessments on safety and tolerability of Cobenfy compared to placebo.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.