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Eisai, Biogen Stop Phase III Trials of Elenbecestat in Mild Alzheimer’s Disease

Eisai, Biogen Stop Phase III Trials of Elenbecestat in Mild Alzheimer’s Disease
Eisai, Biogen Stop Phase III Trials of Elenbecestat in Mild Alzheimer’s Disease
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September 13, 2019
Email: media@alz.org
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CHICAGO — On behalf of the millions of people living with Alzheimer’s disease and their families that we serve and represent, the Alzheimer’s Association is disappointed to learn today that the Phase III studies of elenbecestat in people with early Alzheimer's disease had safety issues, causing Eisai and Biogen to discontinue the clinical trials.
 
The companies state that the “decision is based on the results of a safety review conducted by the Data Safety Monitoring Board (DSMB), which recommended to discontinue these trials due to an unfavorable risk-benefit ratio.”
 
The full trial data should be shared with the field, and the companies have committed to do so. The Alzheimer’s Association looks forward to it being reported at an upcoming scientific meeting.
 
At the Alzheimer’s Association, we will not slow down in our fight against this terrible disease. We will be relentless in our efforts to better understand the causes of Alzheimer’s and other dementias, and to explore additional therapeutic targets. Currently, 5.8 million Americans are living with dementia due to Alzheimer’s. By 2050, this number could nearly triple to 14 million, so our efforts to change the course of Alzheimer’s will continue to be a priority.
 
That said, multiple negative clinical trials targeting BACE (beta amyloid cleaving enzyme) highlights the urgent need to diversify the treatment targets and broaden the therapeutic pipeline for Alzheimer’s and other dementias. Public and private Alzheimer’s research funding is now at unprecedented levels, enabling more diverse and innovative avenues to be explored.
 
Targeted education by the Alzheimer's Association, thousands of advocates and the research community have inspired Congress to champion bold increases in Alzheimer's research. In 2012, annual funding for Alzheimer’s research at the National Institutes of Health was $425 million. Now, it is nearly $2.4 billion — a more than five-fold increase.
 
The Alzheimer’s Association is leading the way in efforts to investigate new treatment strategies and targets. For example, our Part the Cloud program has invested over $30 million to advance more than 30 clinical trials. These studies are targeting a wide variety of known and potential new aspects of the disease, such as inflammation and other promising new targets for therapy.
 
The National Institute on Aging is funding a major data-sharing initiative, known as the Accelerating Medicine Partnership-Alzheimer’s Disease. AMP-AD’s primary goal is to shorten the time between finding potential targets and drug development. Launched in 2012, AMP-AD connects government, industry and nonprofits to share data and expedite drug discovery. AMP-AD has seen dramatic progress in developing web-based tools for the research community and identifying new therapeutic targets for exploration.
 
The Alzheimer’s Association also is leading the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER); the first study of a multi-component lifestyle interventions to protect cognitive function in a large-scale U.S.-based population.
 
Alzheimer’s and other dementias are complex diseases, and their effective treatment and prevention will likely also be a complex – but achievable – task. We must advance all potential treatment targets and also explore methods for combining these approaches. No stone can be left unturned. Even knowing the obstacles, we have never been as optimistic as we are today. The Alzheimer’s Association is confident that we will change the trajectory of this disease.
 

Alzheimer's Association

The Alzheimer's Association is the world's leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimer's disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer's. For more information, visit www.alz.org.

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