Phase III aducanumab trials for Alzheimer's disease stopped early
Pharmaceutical companies Biogen and Eisai today (Thursday 21 March) announced they are to discontinue two phase III trials of the Alzheimer's drug aducanumab. The ENGAGE and EMERGE trials were designed to evaluate the efficacy and safety of aducanumab in people with a confirmed diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's disease.
Aducanumab is an antibody designed to target amyloid, a protein that builds up in the brains of people with Alzheimer's at an early stage in the disease process. Those included in the trial had early memory complaints as well as a PET brain scan confirming a build-up of amyloid in the brain.
The decision to stop the trials is based on an analysis that suggested the trials were unlikely to improve people's memory and thinking sufficiently by the end of the trial. The pharmaceutical companies have said that the recommendation to stop the studies was not based on safety concerns.
Hilary Evans, Chief Executive at Alzheimer's Research UK, said:
"There are hundreds of thousands of people living with Alzheimer's in the UK and this news is clearly disappointing for them and their families. Once the full trial results are available, we must ensure they are shared and analysed in detail so that researchers can learn valuable lessons for the future.
"Alzheimer's brain changes start decades before symptoms start to show and it is possible that anti-amyloid treatments may show benefits if given even earlier in the disease. While improving the early detection of Alzheimer's will help to answer this important question, todays findings reiterate the importance of exploring a range of treatment approaches for the disease.
"Alzheimer's is a complex disease and to reflect this we need a range of drug discovery programmes targeting different aspects of the disease. The Alzheimer's Research UK Drug Discovery Alliance currently has 23 active drug discovery projects targeting harmful brain inflammation and other damaging processes in the disease.
"While today's news is a set-back, it's important to remember there are more than 20 potential Alzheimer's drugs still in final stage clinical trials. We must continue to support the pioneering researchers across the world who are taking us closer to unravelling this complex disease. Now is the time to push even harder for the funding that will accelerate the search for that much-needed Alzheimer's treatment."