The hope was great, Alzheimer finally be able to treat with a drug. Now the disillusionment follows: Two clinical trials to test an Alzheimer's drug have been stopped prematurely. The chances of success are too low, the researchers explained the decision. The tested antibody could not stop the decay of mental capacity as hoped. This had resulted in an analysis by an independent panel of experts.
The company Biogen had tested the active substance Aducanumab since 2017 together with the Japanese pharmaceutical company Eisai for the market launch. Security concerns did not play a role in ending the studies. "It is a disaster for the whole field," commented Hans-Ulrich Demuth from the Leipzig Fraunhofer Institute for Cell Therapy and Immunology.
Further research needed
The two aborted studies with the antibody aducanumab are quite advanced, so-called phase 3 studies. Such pivotal trials are designed to test the efficacy and tolerability of a new drug compared to a dummy drug. Previous research had initially yielded promising results. For example, Biogen researchers in collaboration with Swiss scientists in the journal "Nature" in 2016 reported that the antibody therapy reduces protein deposits that are found in Alzheimer's patients in the brain. In addition, the deterioration of mental capacity seemed to slow down.
The researchers had then examined patients at a very early stage of the disease. Also in the two now discontinued studies, patients were treated with aducanumab in their early stages. The disappointment shows how complex the Alzheimer's disease is, said Biogen CEO Michel Vounatsos. It needs further research to better understand the disease and develop possible therapies.
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According to Demuth, there is little point in continuing ongoing research with antibodies to protein deposits. "It is expensive and in the end disappointing for financiers, relatives, caregivers and especially the patients."
Since the study data have not yet been published, it is currently only possible to speculate why the drug was not sufficiently effective, says Richard Dodel, neurologist at the University of Duisburg-Essen. "As frustrating as it is to have to give up hope for effective therapy in the foreseeable future, this data will help us further, and research always consists of trial and error.
On the stock exchange, the news of the discontinuation of the studies on Thursday led to a fall in Biogen shares of almost 30 percent.