Two pivotal phase 2/3 studies investigating umibecestat (CNP520) for the prevention of Alzheimer disease have been discontinued due to worsening in some measures of cognitive function.
As part of the Alzheimer’s Prevention Initiative Generation Program, umibecestat was being evaluated for safety and efficacy in the prevention or delay of Alzheimer disease onset in patients at high risk for developing symptoms based on their age and genetic status. Study sponsors determined that the potential benefit of umibecestat did not outweigh the risk. Relevant study data will be presented at a future scientific meeting.
“We still believe amyloid plays an important but complex role in Alzheimer’s disease. Although the outcomes of the research program did not lead to the results we aimed for, we are committed to sharing our findings to help advance the medical and scientific community one step further toward finding a prevention for this devastating disease,” said David Reese, MD, executive VP of R&D at Amgen.
Umibecestat is an investigational beta-secretase cleaving enzyme (BACE) inhibitor. Over the past year, several clinical trials investigating other BACE inhibitors have been discontinued due to safety issues (atabecestat, verubecestat) or futility (lanabecestat).
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