Neurimmune kicks off late-stage Alzheimer’s study
Neurimmune and its development partner Biogen are beginning a Phase III study of the companies’ potential Alzheimer’s treatment aducanumab.
The Phase III program, conducted by Neurimmune’s collaborator, Biogen, includes the placebo-controlled studies ENGAGE and EMERGE, which are designed to evaluate the efficacy and safety of aducanumab in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease.
The commencement of the global Phase III studies means the Switzerland-based firm, which specialises in immunotherapies, has triggered a $60 million milestone payment to Neurimmune, as part of a collaborative development and license agreement initiated with Biogen in 2007.
Professor Roger Nitsch, co-founder and president of Neurimmune says: “We are excited about the important progress in the development of aducanumab and the opportunity to systematically determine its effects on slowing the decline of brain function in early Alzheimer’s disease. The consistent progress of our successful collaboration with Biogen, a global leader in the field of innovative therapeutics for brain diseases, is extremely pleasing.
“The start of the Phase III studies of aducanumab for early Alzheimer’s disease marks a major milestone in the development of our company and it validates the ability of Neurimmune’s RTM technology platform for the generation of investigational human antibodies in one of the most difficult-to-treat human diseases.”
Aducanumab is a recombinant human monoclonal antibody targeting amyloid-beta aggregates that are thought to play a role in the neurodegenerative process in Alzheimer’s disease. An interim analysis of the Phase Ib study PRIME showed a dose-dependent, time-dependent, and statistically significant reduction of beta-amyloid from the brain along with an effect on cognition in patients with prodromal or mild Alzheimer’s disease. Biogen also posted positive results for aducanumab at a conference in July.
The clinical trial programme will assess the efficacy and safety of aducanumab in approximately 2,700 people with early Alzheimer’s disease. The studies are identical in design and eligibility criteria. Each study will be conducted in more than 20 countries in North America, Europe and Asia.
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