Bristol Myers Bolsters Scale of Cobenfy Trial After Discovery of Site Irregularities
Data from the ADEPT-2 study for Alzheimer's psychosis, originally hoped for by year-end, is now postponed until late 2026
Bristol Myers Squibb (BMS) has announced an extension and increased enrollment for its late-stage clinical trial, “ADEPT-2,” of the drug Cobenfy (a mind-stabilizing medicine already approved for schizophrenia) as it investigates the drug’s potential effect on moderate to severe psychosis in Alzheimer’s patients.
This adjustment follows the company’s identification of “irregularities” in the way the study was executed at a “small number” of clinical sites.
-
Decisive Action: To safeguard the integrity of the study, BMS opted to exclude patient data from the compromised sites from the primary analysis. After consulting with the Food and Drug Administration (FDA), the company brought in an “independent party” to assess the collected data.
-
Trial Continuation: Based on the assessment, a data monitoring committee recommended that the trial continue and enroll more participants to achieve its original statistical target. BMS is adhering to this advice. ADEPT-2 had previously recruited around 400 patients across 119 locations.
-
New Timeline: The trial results, which analysts had hoped would be available before the end of this year, are now expected by BMS to arrive by the end of 2026.
Market Significance and Reaction
Cobenfy is positioned as a key growth product for BMS, expected to help offset future revenue declines from its current top-selling medications.
The trial readout is highly anticipated by investors due to the large potential market size: approximately 7 million peoplein the U.S. have Alzheimer’s, and it is estimated that between a quarter and a half of these individuals experience associated psychosis.
Although clinical trial delays typically cause stock sell-offs, shares of BMS were up almost 5% by mid-morning on the day of the announcement.
