BMS To Expand ADEPT-2 Trial Enrollment After Site Irregularities; Review Supports Continued ADEPT-2 Development As BMS Advances First-in-Class Muscarinic Therapy for Alzheimer’s Psychosis

Bristol Myers Squibb announced that it will expand enrollment in its ADEPT-2 clinical study after identifying execution-related irregularities at a small subset of trial sites. The issues were discovered during a blinded internal review, prompting the company, prior to database lock, to remove data from those affected sites from the primary analysis. In alignment with the U.S. FDA, BMS commissioned an independent interim evaluation of the study’s safety and efficacy data, which was then reviewed by the Data Monitoring Committee (DMC).

Based on this independent assessment, the DMC advised that the study continue, recommending the enrollment of additional participants to meet the original target population. BMS has accepted this guidance and will resume recruitment while remaining fully blinded to study outcomes.

“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, already approved for treating schizophrenia in adults, is being evaluated as a potential first-in-class therapy for agitation and psychosis rooted in muscarinic receptor agonism. The ADEPT clinical program, which includes ADEPT-1, ADEPT-2, and ADEPT-4, is expected to generate further data for psychosis associated with Alzheimer’s disease by the end of 2026.

BMS emphasised its broad strategy for Alzheimer’s disease, pairing symptomatic therapies with investigational agents designed to slow underlying disease progression. The company stated that its goal is to help restore quality of life for patients, caregivers, and families affected by the disorder.