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CHICAGO – For the first time, a large clinical trial on a drug against Alzheimer's disease has significantly slowed the cognitive decline of patients, offering a promising and unexpected hope to researchers and drug makers at the same time. 39, a conference on Wednesday.
The drug, from Biogen and Eisai, a Japanese company based in Cambridge, has shown significantly better than a placebo to delay the destructive memory effects of Alzheimer's disease on a period of 18 months.
The data, presented at the International Conference of the Alzheimer's Association, positively surprised neurologists who have spent years observing promising therapeutic failures in clinical trials
. got the highest dose of the study, and he removed much of the sticky plaque gumming their brains, drug makers said Wednesday
If the results are confirmed, the drug could be the first to attack both the brain changes and the symptoms of Alzheimer's disease. This test shows that you can both erase the plaque and change cognition, "said Dr. Reisa Sperling, director of the Alzheimer's Research and Treatment Center at Brigham and Women's Hospital in Boston, who does not have a doctor's office. did not participate in the study. "I do not know if we have already managed a homerun It is important not to over conclude on the data but as proof of concept, I have the impression that it is very encouraging. "
But there are reservations. The Phase 2 trial, which used several statistical measures, failed its primary purpose. Four doses of the drug, called BAN2401, did not surpass a placebo, and the high dose was tested on only 161 patients. In addition, the metric used by Biogen and Eisai to measure mental acuity is an internal composite that has never been used to get approval from the Food and Drug Administration
"I will stay cautiously optimistic, "said Dr. Ronald Petersen, director of Mayo. Clinic Center for Research on Alzheimer's Disease. "I think the data is intriguing, the size of the effect seems reasonable, the drug seems safe, and biologically the drug seems to be working
But, he added," you'd really like to see a phase 3 to replicate these results. "
If the drug goes to a phase 3 trial remains an open question.
Despite lingering questions from Wall Street, Biogen and Eisai have not said they'll take a broader study to extract the benefits of BAN2401 or go straight to the FDA with the results of Phase 2 Earlier this month, Dr. Lynn Kramer, chief medical officer of Eisai's division of neurology, said the company considered the Phase 2 trial to be "in the advanced phase" and that 39; he would discuss the possibility of using it
It is unclear whether the FDA will lower the traditionally high bar for Alzheimer's disease therapies, which in the past required two live trials 3 to deserve approval.
If BAN2401 goes away, it could end a bitter disappointment generation in Alzheimer's, which has not seen a new treatment approved in over 15 years. Time and time again, therapies have been promising at the beginning of the tests, but are only empty in the final stages, frustrating patients, doctors and scientists. Meanwhile, the disease is only growing, affecting more than 5.7 million Americans and costing the country more than $ 250 billion a year, according to the Alzheimer's Association.
Biogen's share price rose by nearly 30% predicts modestly positive data from the Phase 2 trial. The actual results exceeded the Wall Street consensus, which allowed Biogen to continue his growth.
Biogen's actions fluctuated after the publication of the study results. After changing gains and losses several times, it dropped by 6.5%.
BAN2401 is part of a group of treatments for Alzheimer's disease based on the idea that toxic plaques called amyloid are responsible for the corrosive effect of the disease on the brain . The so-called amyloid hypothesis is supported by ramifications of genetic data, but no drug targeting these plaques has ever been able to significantly affect the disease in a large trial.
This is what made such a surprise to BAN2401. In the Phase 2 trial, the highest dose of the drug had a marked effect on amyloid accumulation in the brain, with 81% of patients passing from amyloid-positive to amyloid-negative. And in addition to its effect on the measure of Eisai cognition, the dose recorded a 47% reduction in cognitive decline compared with placebo on a well-known metric called ADAS-cog
"C & # 39; that's what really gives me the impression they're on something, that it's a real effect that we're seeing, "said Dr. Jim Hendrix, Director of Global Science Initiatives at Alzheimer's Association.
The next step, he said, should be to register another, larger trial that isolates the best dose of BAN2401 and tests whether it can replicate its promise.
Material from the New York Times and the Associated Press was used in this report.
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