The FDA has recently begun outlining new guidelines that are designed to encourage drug developers to start testing their drugs intended to treat Alzheimer's patients much earlier in the disease process. There have been several high-profile attempts to prove new therapies in huge Phase III programs, and each has failed decisively in mild to moderate patients--possibly because many of the patients' brains are already too damaged to respond to the drugs now in the clinic. But to test early-stage patients, investigators also have to develop tests that can effectively identify at-risk patients with a mild form of the disease, zeroing in on key biomarkers.
With that in mind, Merck ($MRK) and Luminex recently struck a deal that steers the diagnostic group right into the rapids of high-profile R&D work in the field. Luminex will put its technology to work on a test that can flag two key biomarkers for Alzheimer's--Aβ42 and t-tau--in cerebrospinal fluid.
"This collaboration has the potential to deliver a novel companion diagnostic to identify patients at increased risk of developing Alzheimer's disease," said Patrick J. Balthrop, president and CEO of Luminex. "We are pleased to leverage our technologies and development capabilities and look forward to expanding our activity into the companion diagnostic segment of personalized medicine."
It's an extraordinarily tricky business. As the companies' release notes, the only decisive diagnosis of Alzheimer's is made during a post-mortem procedure. But experience tells us that toxic concentrations of beta amyloid and tau tangles are a common characteristic of the disease. Merck's theory, which it will put to the test in a Phase II/III study of MK-8931 in mild to moderate patients, is that by inhibiting beta-secretase it can put a stop to the development of amyloid beta, preventing the further development of the toxic material.
Experts in the field have tried the same approach on gamma secretase, only to find out that they also put a stop to some vitally important processes in the body. And some feel that the BACE attack may result in the same issues. Merck and Luminex have one of several BACE agents in the clinic, and may be among the first to answer a basic question: Is it safe?
- here's the press release
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