Pharma companies relying on biomarkers to test Alzheimer's drugs

There is a growing consensus that, in absence of a cure for Alzheimer's disease, not only are pharmaceutical companies and researchers placing more emphasis on early detection and diagnosis, but the search for biomarkers is a crucial component of this new focus. Not everybody agrees on the cause of the degenerative memory-stealing disease, but there is a general consensus that extracellular amyloid-beta (Aß) plaques and intraneuronal tangles in the brain, along with masses of tau protein, are to blame. Drugs being developed tend to target these plaques. But, at best, they hold off symptoms temporarily. In fact, by the time treatment starts, it is often already too late. The Wall Street Journal outlines these problems in an article that updates us on the growing search for Alzheimer's biomarkers.

"Earlier intervention will allow us to treat patients when they have much less disability and when it could still be possible to prevent or delay such [memory] losses," Howard Feldman, Bristol-Myers Squibb's vice president of global clinical research for neuroscience, tells the WSJ. Companies like Pfizer ($PFE), Johnson & Johnson ($JNJ) and Bristol-Myers Squibb ($BMY) are increasing their focus on patients with mild symptoms of memory loss, the paper reports.

But there needs to be more than simply patients with memory loss participating in drug studies. Subjects need to be chosen based on the likelihood that their symptoms will progress to full-blown Alzheimer's. That's where biomarkers can realize their usefulness to pharma. Bristol-Myers, for example, is picking test subjects for its testing of a drug called avagacestat based on measurement of Alzheimer's-associated biomarkers in the brain and spinal fluid. These subjects have mild or even no symptoms, but only have these biomarkers in common. Eli Lilly ($LLY) and Pfizer are using biomarkers in the same way, the WSJ reports.

The paper reminds us that, as usual in research at this stage, there are no certainties. Not all Alzheimer's-associated biomarkers--and more than 100 new ones were presented recently at an Alzheimer's conference in Paris--are conclusively linked to the disease. None of these efforts assures success, and a lot of work needs to be done before these biomarkers conclusively prove to be linked to progression of the disease. But, Lilly's Eric Siemers tells the WSJ, there's a broad acknowledgment of how important it is."

- read the WSJ story

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