After a review of clinical data from the Generation Program studies, Novartis, Amgen and Banner Alzheimer's Institute have decided to discontinue investigation of the BACE1 inhibitor CNP520 (umibecestat) in two pivotal Phase II/III studies in the Alzheimer's Prevention Initiative Generation Program.
The decision was made as patients symptoms continued to worsen during the treatment, and sponsors concluded that the potential benefit for participants in the studies did not outweigh the risk.
CNP520 was being assessed for safety and efficacy in the prevention or delay of the onset of Alzheimer's in people at high risk for developing symptoms based on their age and genetic status, but participants have now been advised to stop taking the treatment.
The study sponsors intend to further assess and present the data at a future scientific venue. Dr Tsai, head of Global Drug Development and chief medical officer said that beyond presenting the analysis, the company “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 organisations, patient groups, pharmaceutical companies, and society, to ensure that we collectively address the public health challenges presented by this disease."
Alzheimer's is a complex disease and one of the largest challenges facing healthcare today, with lots of failed treatments in past pipelines.
Earlier this year Biogen and Eisai stopped two global Phase III trials of the Alzheimer's drug aducanumab, after interim analyses indicated that the agent was ineffective and would not meet the primary endpoint.