Bristol Myers Squibb Announces Continuation of ADEPT-2 Phase 3 Study in Psychosis Associated with Alzheimer's Disease
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.
"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, 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.
About ADEPT-2
The ADEPT-2 study (clinicaltrials.gov, NCT06126224) 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), with additional assessments on safety and tolerability of Cobenfy compared to placebo.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility of unfavorable results from further clinical trials involving Cobenfy and whether Cobenfy for the additional indications described in this release will be successfully developed and commercialized. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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