Novartis and Amgen are expanding their collaboration with the Banner Alzheimer’s Institute, launching a new study to assess whether their drug will slow the progression of Alzheimer’s disease.
BACE drugs like CNP520 essentially seek to interfere in the process that creates amyloid beta, a toxic protein often found in the brains of Alzheimer’s patients. As the top amyloid beta drugs like bapineuzumab and solanezumab — which sought to extract existing amyloid beta loads — experienced repeated failures, drug makers are increasingly turning to BACE therapies as an alternative mechanism that could slow the disease down.
“This approach continues to shift the Alzheimer’s research paradigm from reversing disease damage to attacking its root cause before symptoms surface,” said Vas Narasimhan, global head of drug development and chief medical officer at Novartis. “It is our hope that by targeting people earlier, we will have a better chance of delaying or preventing the onset of the disease.”
This is the second BACE study involving Novartis, Amgen and Banner. The first one, which the partnership is calling Generation Study 1, was announced in 2014 and launched last year. The study, funded by a $33.2 million NIH grant, was only looking at patients who carried two copies of the apolipoprotein E (APOE) 4 gene, which is a major genetic risk factor for late-onset Alzheimer’s.
With this second study, however, the group is looking at patients who only have one copy of the gene.
“Roughly one in four people carry a single copy of the APOE4 gene, but only about two percent of the world’s population carries two copies,” the Banner press release states.
Patients with only one copy will need evidence of elevated brain amyloid to be included in the trial.
The latest trial, called Generation Study 2, started enrolling patients in August, and will eventually include more than 180 sites around the world. The five-year study will recruit 2,000 cognitively healthy participants, aged 60 to 75, who are at high risk of developing AD based on their age and genetic makeup.
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