Print“Our goal was to examine historical trends to help understand why Alzheimer’s disease treatment development efforts so often fail, says Jeffrey Cummings, director of the Cleveland Clinic Lou Ruvo Center for Brain Health.”
An analysis of clinical trials for Alzheimer’s disease finds that almost all of the drugs in development between 2002 and 2012 failed. The first-ever analysis, conducted by researchers at the Cleveland Clinic Lou Ruvo Center for Brain Health, also found that the number of drugs in development for one of the most debilitating diseases of aging is relatively small and has been declining since 2009.
Their paper, “Alzheimer's Disease Drug Development Pipeline: Few Candidates, Frequent Failures,” was published in the current edition of the journal Alzheimer's Research & Therapy.
“Our goal was to examine historical trends to help understand why Alzheimer’s disease treatment development efforts so often fail,” says Jeffrey Cummings, director of the Cleveland Clinic Lou Ruvo Center for Brain Health. “With an estimated 44 million people living worldwide with the condition, the study shows that the Alzheimer's disease drug development ecosystem needs more support given the magnitude of the problem.”
Using the advanced search mechanisms of ClinicalTrials.gov, a government website that records all ongoing clinical trials, Cummings, along with Kate Zhong, senior director of clinical R&D, and Touro University medical student Travis Morstorf, constructed a comprehensive analysis to examine all trials since 2002.
“By analyzing both completed as well as on-going trials and currently active compounds, we were able to provide insight into longitudinal trends in drug development,” says Zhong. “What we found was that the investment in AD drugs and therapies is relatively low compared to the challenge posed by the disease. The pipeline is almost dry.”
Big Pharmas such as Eli Lilly, Pfizer, and Johnson & Johnson have all had to discontinue late-stage programs due to the failure of their Alzheimer’s drugs in development. While Merck recently partnered with Australian biotech Bionomics to develop an early-stage Alzheimer’s therapeutic, the Cleveland Clinic researchers found just 30 early-stage trials of experimental drugs in the ClinicalTrials.gov database.
While the National Institutes of Health has called for $4.5 billion over the next 12 years to fund brain research, it is a drop in the bucket compared to federal funding for cancer research.
With the high rate of failure of compounds targeting Alzheimer’s, more effort is needed to support and improve the success rate of experimental AD therapies, say the Cleveland Clinic research team. In order to accelerate the drug development process and reduce the need to constantly invent new drugs, the researchers suggest more repositioning studies, which involve studying an already-approved drug in a new use or condition. Cummings is currently conducting a mid-stage study to determine if bexarotene, marketed by Eisai as Targretin and approved to treat skin cancer, can remove a protein build-up in the brains of Alzheimer's patients, as it did in a recent animal study.
July 06, 2014
http://www.burrillreport.com/article-most_experimental_alzheimers_drugs_fail_in_trials.html
