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Novartis and Amgen stop two Phase II/III clinical studies of CNP520 in the Alzheimer's Prevention Initiative Generation programme

Thursday 11 July 2019

On 11 July, the pharmaceutical companies Novartis and Amgen, along with their partner the Banner Alzheimer's Institute, announced the decision to discontinue two Phase II/III clinical trials in the Alzheimer's Prevention Initiative (API) Generation programme based on a planned analysis.

The trials focus on the experimental drug CNP520 that was designed to inhibit BACE1, an enzyme that plays an important role in the production of beta-amyloid. Both studies are randomised, double-blind and placebo-controlled trials investigating the efficacy and safety of the CNP520 in people at high risk of developing symptoms of Alzheimer’s disease (AD) based on their age and genetic status. The pharmaceutical companies planned to enrol more than 3.300 research participants in America, Australia and Europe. The review of unblinded data reported that participants receiving the experimental drug worsened on some measures of cognitive function. The study sponsors concluded that the potential benefit for participants taking CNP520 did not outweigh the risks. Data will be presented at upcoming conferences.

"Beyond presenting our analyses, we will go a step further and will also share our data with the scientific community, not only to contribute to the increasing body of knowledge in Alzheimer's research but to add value to ongoing discussions with governments, multilateral organizations, patient groups, pharmaceutical companies, and society, to ensure that we collectively address the public health challenges presented by this disease.”, said John Tsai, head of global drug development and chief medical officer at Novartis.