Novartis makes Alzheimer’s deal
pharmafile | July 16, 2014 | News story | Research and Development, Sales and Marketing | Alzheimer's, Genentech, Novartis, bai, epstein
Novartis is to collaborate with the Banner Alzheimer’s Institute (BAI) to test two of the Swiss company’s investigational anti-amyloid treatments.
They will be evaluated separately in a five-year trial in North America and Europe with volunteers at high risk for developing the neurodegenerative disease because they inherited two copies of the apolipoprotein E (APOE4) gene – one from each parent.
The first Novartis drug is an active immunotherapy aimed at triggering the body’s immune system to produce antibodies which attack the amyloid protein, while the second is an oral BACE (beta-secretase1) inhibitor, designed to prevent the production of different forms of the same protein.
The hope is that one or both of them can prevent altogether or at least delay the symptoms of Alzheimer’s, such as memory loss, in this high-risk group of 1,300 cognitively healthy adults aged 60 to 75: they will receive either the active immunotherapy, the oral medication or a placebo.
It is thought that 2% of people worldwide carry two copies of the APOE4 gene – and one in four carry one copy – which is strongly linked to late-onset Alzheimer’s. The two products are intended to stop the accumulation of amyloid before it begins in participants’ brains.
The APOE4 trial is set to start next year at 60 or so sites across the two continents, including BAI’s headquarters in Phoenix, Arizona, and is funded by $33.2 million from the National Institutes of Health (NIH), part of the US Department of Health and Human Services, and more than $15 million in philanthropic contributions by Banner Alzheimer’s Foundation.
The programme is part of the BAI’s international Alzheimer’s Prevention Initiative, which seeks to push research on promising therapies forward.
“We hope Novartis’s substantial investment of resources and expertise will lead to a significant breakthrough in Alzheimer’s research,” says Pierre Tariot, study director for BAI.
“We are taking clinical trials to a critical new stage,” he adds. “This approach shifts the research paradigm from trying to reverse disease damage to attacking and preventing its cause, years before symptoms could surface.”
David Epstein, division head of Novartis Pharmaceuticals, says: “There is a huge unmet need for treatments that prevent or delay the development of the disease and we are excited about taking research in Alzheimer’s to the next level.”
BAI is already working on a $100 million study looking at cognitively healthy people who will probably develop Alzheimer’s at an unusually early age because of their genetic history.
Funded by NIH, BAI and biotech firm Genentech, it is evaluating the amyloid antibody agent crenezumab with 300 members of a family from Colombia who share a rare genetic mutation that typically triggers symptoms around 45 years of age.
Adam Hill
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