After a review of the clinical data, sponsors Amgen and Novartis have concluded that the potential benefit for participants in a Alzheimer’s disease program did not outweigh the risk. Hence, the prominent industry sponsors are discontinuing the studies.
What is the Situation?
Amgen, Novartis and Banner Alzheimer’s Institute announced the collective decision to discontinue investigation of the BACE1 inhibitor CNP520 (umibecestat) in two pivotal Phase 2/3 studies in the Alzheimer’s Prevention Initiative Generation Program.
What is the Alzheimer’s Prevention Initiative Generation Program?
It was a program designed to research the safety and efficacy of CNP520 for the prevention or delay of the onset of Alzheimer disease in people at high risk for developing symptoms based on age and their genetic status.
What is CNP520 (Umibecestat)?
It is an oral therapy that Novartis and Amgen have been developing to delay the start and progression of Alzheimer’s disease.
How does CNP520 Work?
The hallmark of Alzheimer’s is an accumulation of toxic amyloid beta protein in the brain, which is thought to cause brain cell death and cognitive decline. An enzyme called BACE1 paves the way to the accumulation process of this protein by cutting another protein called APP (amyloid precursor protein) into smaller fragments which then form amyloid beta plaques.
CNP520 is a BACE1 inhibitor. It is designed to prevent the BACE1 enzyme from cutting up the APP, a move that should curb amyloid beta accumulation. Studies in human cells in a laboratory setting and in mice have evidenced that CNP520 can prevent the formation of amyloid beta plaque.
David Reese, MD, executive vice president of Research and Development at Amgen reported “Our team joins the millions whose lives are impacted by Alzheimer’s disease in our disappointment that the Generation Program did not yield a treatment for Alzheimer’s disease prevention.” Reese continued, “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.”