Analysts had noted “unease” from investors regarding the state of the Phase III ADEPT-2 trial, with BMS at one point telling Leerink Partners that the reopening of enrollment would be a “significant development.”
A closely watched readout for Bristol Myers Squibb’s Cobenfy in Alzheimer’s disease psychosis has been delayed to 2026 after the pharma was forced to recruit additional patients into the trial.
In a press announcement on Wednesday, BMS said it detected “irregularities” in the Phase III ADEPT-2 study linked to the execution of the trial “at a small number of study sites.”
The pharma did not specify what these irregularities were, which sites were affected and how these anomalies could affect the integrity of the collected data.
BMS nevertheless excluded data from these compromised sites and, after consulting with the FDA and with an external monitoring committee, decided to enroll more patients into the trial. The company remains blinded to study data.
Analysts appear to have had an inkling that ADEPT-2 had run into some trouble. According to an Oct. 30 note from Leerink Partners, BMS executives were asked during their Q3 earnings call whether they had reopened enrollment for the study at certain sites. A spokesperson, however, told the firm later that “there has been no clinical trial update on ADEPT-2, and any reopening of enrollment would be a significant development.”
At the time, Leerink expected ADEPT-2 to read out by the end of 2025.
On Wednesday, however, BMS noted that “additional trial results from the ADEPT program,” which includes ADEPT-2, as well as ADEPT-1 and ADEPT-4, “are expected to read out by the end of 2026.”
BMO Capital Markets, writing in a note to investors Wednesday morning, likewise alluded to the “feelings of unease from investors” regarding the ADEPT-2 readout. “Shifting commentary from management has prompted concern from some investors that the ADEPT-2 trial would fail,” the analysts wrote, however noting that relative to an outright failure, the news of the delay “is likely to be viewed a positive.”
Cobenfy, a muscarinic antipsychotic, is the main prize BMS acquired when it bet $14 billion in December 2023 to buy Karuna Therapeutics. While this investment paid off less than a year later with the FDA’s approval of the drug for schizophrenia in September 2024, Cobenfy has since run into a rough patch.
In April this year, the pharma reported disappointing findings from the Phase III ARISE study, which tested Cobenfy as a supplement to atypical antipsychotics. While add-on Cobenfy showing improvements on a scoring scale for assessing schizophrenia symptoms, its treatment effect fell short of statistical significance.
For Leerink, that late-stage stumble cast doubt on Cobenfy’s profile as a product, with analysts writing in an April 23 note that the drug could have “far less potential than we originally anticipated.” At the time of the ARISE fail, BMS said it would discuss the path forward for Cobenfy in this indication, but the pharma revealed in late July that no such talks with health regulators had yet occurred.
