December 10, 2014

Interim analysis of Phase 1b study of Aducanumab / BIIB037 to treat Alzheimer’s disease shows reduction in beta amyloid levels and acceptable safety profile

Zurich, Switzerland. Neurimmune’s recombinant human monoclonal antibody Aducanumab / BIIB037 targeting Abeta aggregates reduced beta-amyloid levels in the brain, and improved cognition in patients with prodromal or mild Alzheimer’s disease. These study results were observed in a prespecified interim analysis of the Phase 1b trial conducted by Neurimmune’s collaboration partner Biogen Idec, Cambridge, MA.

Douglas Williams, Executive Vice President of R&D of Biogen Idec, announced at Deutsche Bank’s BioFEST investors’ conference on Dec 2, 2014, that Aducanumab / BIIB037 is being prepared for a Phase 3 trial. The interim analysis showed a dose-dependent, time-dependent, and statistically significant reduction of beta-amyloid from the brain along with an acceptable safety profile to date. Furthermore, in exploratory analyses, statistically significant improvement on cognition was observed at week 54. Biogen will continue the current study in a blinded fashion to the 12 month visit. Williams said Biogen is likely to present data at a major scientific congress in 2015.  

Aducanumab / BIIB037 is a recombinant human monoclonal antibody targeting Abeta aggregates that play a role in the neurodegenerative process in Alzheimer’s disease. Aducanumab /  BIIB037 is currently being investigated in a Phase 1b study in patients with prodromal and mild Alzheimer’s disease and a positive PET amyloid at baseline. The recombinant human antibody was generated by Neurimmune’s Reverse Translational MedicineTM technology platform and was licensed to Biogen Idec in 2007. Neurimmune and Biogen Idec expanded their collaboration in 2010 with immunotherapy programs targeting tau, alpha-synuclein and TDP-43 for the treatment of related neurodegenerative diseases.