Bold takeaway: Bristol Myers Squibb is pressing ahead with ADEPT-2 despite irregularities at a few sites, underscoring a commitment to rigorous science while navigating complex trial data.
Bristol Myers Squibb (BMS) announced plans to enroll more participants in the ADEPT-2 Phase 3 study, which evaluates Cobenfy for psychosis associated with Alzheimer's disease. This decision comes after a blinded review of the trial data identified irregularities at a small subset of study sites. To preserve the integrity of the primary analysis, data from those sites were excluded before database lock, and an interim efficacy and safety analysis was performed by an independent party and reviewed by the Data Monitoring Committee (DMC) with FDA consultation.
The DMC authorized continued enrollment to reach the original target population. BMS remains blinded to the study data throughout this process. Laura Gault, MD, PhD, Senior VP and Head of Development for Neuroscience Drug Development at BMS, stated that continuing the Phase 3 study and recruiting additional patients aligns with FDA and DMC guidance. She emphasized that excluding data from sites with irregularities reflects a strong commitment to trial integrity and to addressing the substantial unmet need in Alzheimer’s disease-related psychosis.
Cobenfy is approved for schizophrenia in adults and may represent a first-in-class approach targeting agitation and psychosis via muscarinic receptor activation. Additional ADEPT program results—involving ADEPT-1, ADEPT-2, and ADEPT-4—are anticipated by the end of 2026.
BMS is pursuing a holistic strategy for Alzheimer’s disease, combining attempts to slow disease progression with symptom relief to restore some quality of life for patients, families, and caregivers.
About ADEPT-2: ADEPT-2 (NCT06126224) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial assessing the safety and efficacy of Cobenfy in individuals with psychosis linked to Alzheimer’s disease dementia. The primary endpoint is the change in the Neuropsychiatric Inventory-Clinician (NPI-C) Hallucinations and Delusions (H+D) score, with the Clinical Global Impression-Severity (CGI-S) as a key secondary endpoint, plus safety and tolerability assessments.
About Bristol Myers Squibb: BMS is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines to help patients prevail over serious diseases. More information is available at BMS.com and via company social channels.
Forward-looking statements: This release contains forward-looking statements about the company’s research, development, and commercialization plans for Cobenfy and other programs. These statements involve risks and uncertainties, including potential unfavorable trial results and regulatory outcomes. Actual results may differ due to factors described in the company’s risk disclosures and SEC filings. BMS undertakes no obligation to update these statements unless required by law.
