Bristol Myers Squibb To Enroll Additional Patients In ADEPT-2 Study

Study Continuation Follows Review of Site Level Data and Recommendation of Data Monitoring Committee

BMS Remains Blinded to Study Data

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.

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.