antibody being jointly developed by Cambridge, Massachusetts-based neurological and autoimmune disease therapies specialist Biogen (NASDAQ: BIIB) and Tokyo-based pharmaceutical company Eisai Co.
announced today that an Independent Data Monitoring Committee has determined that BAN2401, an anti-amyloid beta protofibril
antibody, did not meet the criteria for success based on a Bayesian analysis at 12 months as the primary endpoint in an 856-patient Phase II clinical study (Study 201).
Safety and tolerability of BAN2401--a clinical study in Alzheimer's disease with a protofibril
selective Ap antibody.
Kelly, "The oxidative stress metabolite 4-hydroxynonenal promotes Alzheimer protofibril
formation," Biochemistry, vol.
These atypical mutations are generally believed to cause A[beta] accumulation by augmenting aggregation or protofibril
Distinct effects of Zn2+, Cu2+, Fe3+, and Al3+ on amyloid-beta stability, oligomerization, and aggregation: amyloid-beta destabilization promotes annular protofibril
Four keratin helices twist around each other to form a protofibril
In addition, AEF appears to act as a protofibril
or focus of [Beta]-sheeting (the "nidus" theory).
Furthermore, Eisai's and Biogen's respective milestone payments under the original agreement for aducanumab and BAN2401, an anti-A beta protofibril
antibody, have been eliminated.
Lansbury, "Kinetic stabilization of the [alpha]-synuclein protofibril
by a dopamine-[alpha]-synuclein adduct," Science, vol.
Based on this agreement, Eisai and Biogen will co-develop Eisai's investigational next generation AD treatment candidates E2609, a BACE inhibitor, and BAN2401, an anti-amyloid beta (Abeta) protofibril
antibody, in major markets, such as the United States, the European Union and Japan.
Essential conformational changes occur during protofibril
formation where the unstructured, [alpha]- helix, and [beta]-strand elements transform into [beta]-sheet/[beta]-turn structures.