AC Immune Therapy chosen for ground-breaking Alzheimer´s Disease Trial

The groundbreaking study – the world’s first to investigate whether an anti-amyloid treatment can stave off the disease – is being run by a collaboration of the US National Institutes of Health (NIH), the Banner Alzheimer´s Institute (BAI), the University of Antioquia in Colombia and Genentech. The USD 100 million trial will study the experimental anti-amyloid antibody treatment called crenezumab in approximately 300 people. Crenezumab was discovered by AC Immune and exclusively out-licensed in 2006 to Genentech.

Prof. Andrea Pfeifer, CEO of AC Immune commented: "We are proud that this antibody developed from our technology platform has been chosen to be the first drug candidate ever to be investigated in a prevention trial in Alzheimer´s disease. Scientists agree that promising experimental drugs should be tested years before a person is diagnosed with this terrible disease. We are delighted that our partner Genentech is taking this clinical leadership as part of the landmark Alzheimer’s Prevention Initiative.”

“We are honored by this recognition of our company’s leading role in finding innovative therapies for one of the world’s most pressing medical burdens; it validates Switzerland’s pre-eminence as a center for biotechnology excellence,” continued Prof. Pfeifer.

Currently, most Alzheimer’s treatments are being tested in patients with mild to moderate stage disease after a person has been diagnosed and has lived with Alzheimer’s symptoms for some years already. Many in the clinical and scientific community believe that by the time memory begins to slip and other thinking problems emerge, too much damage may already have occurred for some treatments, such as those focusing on amyloid, to be effective. They suspect that these potential therapies must instead be started before the onset of symptoms.

About the Alzheimer´s prevention trial
The USD 100 million trial is the cornerstone of a new international collaborative, the Alzheimer’s Prevention Initiative (API), formed to accelerate the evaluation of promising but unproven prevention therapies. It will study the experimental anti-amyloid antibody treatment called crenezumab in approximately 300 people from an extraordinarily large extended family in Colombia, who shares a rare genetic mutation that typically triggers Alzheimer’s symptoms around age 45. The trial will also include a small number of individuals in the United States. A key characteristic of this group of patients is that they have a predictable onset and near certainty of disease compared to sporadic Alzheimer’s disease.

The trial is designed to determine whether the drug can reduce participants’ chances of developing the disease’s disabling and irreversible symptoms, preserve memory and thinking abilities, and slow the progression of Alzheimer’s biomarkers. If the treatment’s effects on brain imaging and other biological measurements of the disease are shown to predict its clinical benefit, the study could establish a much more rapid way to test future therapies.

NIH has awarded a USD 16 million, five-year grant for the study, and BAI has committed USD 15 million in philanthropic funds. Genentech will contribute the major share of funding, in addition to providing study drug and clinical and operational expertise integral to the design and conduct of the study. Given the importance of the trial, data and findings will be shared publicly after its completion to help the entire Alzheimer’s research community find faster ways to test promising prevention therapies.