ZURICH, August 31, 2016 /PRNewswire/ --
Scientists at Neurimmune today described results from the Phase 1b PRIME clinical trial of the monoclonal antibody aducanumab. The report, published in the journal Nature, showed that aducanumab removed amyloid plaques from the brains of patients with early-stage Alzheimer's disease. Importantly, amyloid plaque reductions occurred in both a dose- and time-dependent manner.
After one year, in patients receiving aducanumab, the levels of amyloid plaques, visualized using positron emission tomography (PET), were substantially reduced. There was also evidence that aducanumab slowed cognitive decline in these patients. Importantly, if confirmed by future trials, these results provide compelling support for the hypothesis that amyloid build-up is a key factor in driving cognitive decline in Alzheimer's disease.
Aducanumab has been developed in collaboration with the leading pharmaceutical company Biogen, and is the product of Neurimmune's proprietary Reverse Translational Medicine™ (RTM™) technology platform.
Professor Roger M Nitsch, MD, Co-Founder and President of Neurimmune said: "These results potentially represent a major step forward in the fight against Alzheimer's disease; the magnitudes of the effects as well as their time- and dose-dependency are truly intriguing" He added: "Aducanumab also demonstrates a proof-of-concept for our RTM™ technology platform. It gives us further evidence that our approach is working and provides promise for many of the other drugs we are developing using this technology"
Regarding safety, transient amyloid-related imaging abnormalities (ARIA) were the most important findings. In most cases with ARIA, the imaging finding occurred in the absence of clinical symptoms, and in symptomatic cases ARIA was accompanied by mild to moderate headaches, which were also transient. To confirm the early findings on clinical stabilization, large-scale Phase 3 clinical trials of aducanumab (ENGAGE and EMERGE) are now underway at more than 300 study sites across 20 countries in North America, Europe and Asia, and these will assess the efficacy and safety of the drug in approximately 2,700 people with early Alzheimer's disease. For more information about the Phase 3 studies, including information about participating, visit http://www.clinicaltrials.gov (NCT02477800, NCT02484547).
Aducanumab is an investigational compound being developed for the treatment of early Alzheimer's disease. Aducanumab is a human recombinant monoclonal antibody derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly people with unusually slow cognitive decline, using Neurimmune's proprietary Reverse Translational Medicine™ (RTM™) technology platform.
Aducanumab targets aggregated forms of beta amyloid, including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of patients with Alzheimer's disease. The global ENGAGE and EMERGE Phase 3 studies conducted by Biogen are primarily designed to determine the effect of aducanumab on brain function in early Alzheimer's disease. Neurimmune out-licensed the rights for aducanumab to Biogen under a collaborative development and license agreement in 2007.
Neurimmune is a biopharmaceutical company dedicated to the development of unique classes of human therapeutic antibodies for the treatment and prevention of important human diseases with a high unmet medical need. Established in 2006 as a spin-off of the University of Zurich, Switzerland, Neurimmune has rapidly grown into a leader in the field of recombinant human monoclonal antibody therapeutics. Neurimmune's pipeline comprises high-potential drug candidates at both clinical and advanced preclinical development stages for Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, type 2 diabetes and cardiomyopathy. Neurimmune pursues an out-licensing model with its candidate human monoclonal antibody programs, and is dedicated to forging successful collaborations with world leaders in the biopharmaceutical industry.
Jan Grimm, Ph.D.
Chief Scientific Officer & Director
Neurimmune Holding AG