Bristol Myers To Enroll Addl. Patients In Phase 3 ADEPT-2 Study Following Regulatory Consultations

(RTTNews) - Bristol Myers Squibb (BMY) announced Wednesday that it agrees with the decision made in consultation with the U.S. Food and Drug Administration (FDA) and Data Monitoring Committee (DMC) to continue the Phase 3 study and will move forward to enroll additional patients in the ADEPT-2 study.

The company had identified irregularities due to clinical trial execution at a small number of study sites. With these findings, prior to database lock, the company made the decision to exclude patient data from those sites from the primary analysis, following a thorough blinded review of the ADEPT-2 study data.

Following consultation and agreement with the FDA, an interim data analysis for efficacy and safety was conducted by an independent party and reviewed by the DMC.

Following this analysis, the DMC recommended the study continue by enrolling additional patients to the original target study population. The company 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.

The ADEPT-2 study 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).