Bristol Myers Squibb & Co. (NYSE: BMY) on Wednesday said it would enroll additional patients in the ADEPT-2 Phase 3 study.
The ADEPT-2 study is a 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.
What is Cobenfy?
Cobenfy is currently approved for schizophrenia in adults.
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, before the database lock, the US-based drug giant decided 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 that the study continue by enrolling additional patients to the original target study population. Based on this recommendation, Bristol Myers will continue patient enrollment and advance the program as advised by the DMC. Bristol Myers remains blinded to study data.
Analyst Take
William Blair on Wednesday wrote, “The ADEPT-2 study was highly anticipated by investors given the size of the market opportunity, need for momentum in the Cobenfy clinical trial launch, and recent setbacks with other late-stage programs at Bristol Myers.”
Analyst Matt Phipps points out that a delay tied to site issues usually worries investors, but the IDMC and FDA backing continued enrollment points to potentially encouraging early signals in the data.
Phipps notes that given the pressure on Bristol Myers shares, any non-failure could be good news.
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, compared to the end of 2025 expected earlier.
In November, Bristol Myers Squibb, in collaboration with Johnson & Johnson (NYSE: JNJ), decided to stop the Phase 3 Librexia ACS trial of milvexian when added to the standard of care (conventional antiplatelet therapy) for patients after a recent acute coronary syndrome (ACS) event.
The decision to discontinue the trial follows a preplanned interim analysis by the Independent Data Monitoring Committee (IDMC), which determined the trial is unlikely to meet the primary efficacy endpoint.