Print“Although current medications are sometimes effective in helping lessen the symptoms of Alzheimer’s disease its complexity has stymied numerous attempts to cure or stop its progression.”
An experimental Alzheimer’s therapy developed by Pfizer, Elan, and Janssen failed to help patients with a mild-to-moderate case of the disease and a genetic risk factor for the disease. Compared to a placebo, the drug neither improved daily functioning nor cognition for patients who carry the ApoE epsilon 4 genotype, a genetic risk factor for Alzheimer’s disease.
The closely watched drug, bapineuzumab, is an antibody that targets beta-amyloid, a protein that can exert toxic effects in the brain and is believed to play a central role in the pathology of Alzheimer’s disease. While Pfizer says it is disappointing that the drug failed to show an impact on ApoE4 carriers, the result was also not wholly surprising, since an earlier mid-stage trial also showed little impact on carriers of the gene.
“While we have high hopes for every Alzheimer’s and dementia therapy trial, history shows that progress is incremental and we will have setbacks along the way,” said The Alzheimer's Association in a statement about the trial. “These setbacks also provide critical information to the research community for application in future studies.”
Bapineuzumab remains in testing with both ApoE4 carriers and those who don’t carry the gene. Results of a non-carrier study will be released later this summer, the companies say.
An estimated 5.4 million Americans have Alzheimer’s disease, the most common form of dementia, according to The Alzheimer's Association. About 36 million patients worldwide have the disease. That number is expected to double over the next 20 years and to triple to more than 116 million by 2050.
Although current medications are sometimes effective in helping lessen the symptoms of Alzheimer’s disease, such as memory loss and confusion, its complexity has stymied numerous attempts to cure or stop its progression.
In 2010, Pfizer and Medivation ended development of dimebon, their experimental drug to treat Alzheimer’s disease, after it failed in two late-stage clinical trials. Later that year, Eli Lilly said it would halt development of semagacestat, its experimental drug to treat Alzheimer’s, because preliminary results from two long-term late-stage studies showed it failed to slow disease progression and was associated with worsening of cognition and the ability to perform activities of daily living.
Now that Pfizer has reported on its latest effort in the space, Lilly won’t be far behind. It is expected to report the latest trial results for its experimental Alzheimer’s therapy solanezumab, also an antibody to fight the build-up of beta amyloid, before the end of the third quarter.
Because of the difficulty of reversing brain damage caused by the disease, efforts to spot Alzheimer’s early in its progression have gained momentum. Nonetheless, efforts to address and improve the symptoms of the disease will remain important, since early detection remains difficult.
July 26, 2012
http://www.burrillreport.com/article-alzheimer%e2%80%99s_drug_fails_late_stage_trial.html
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