Eisai and Biogen have announced that a Phase III trial has been initiated for the anti-amyloid beta protofibril antibody BAN2401, for use in patients with early Alzheimer's disease.
The news comes just days after the companies stopped two global Phase III trials of its previous Alzheimer's drug, aducanumab, after interim analyses indicated that the agent was ineffective and would not meet the primary endpoint.
Biogen caused a stir with the investigational drug back in 2014 by saying that it was moving it into Phase III on the back of promising early-stage data in which patients exhibited statistically significant cognitive improvements by 54 weeks, at a time when the Alzheimer’s field was littered with failed compounds.
The two companies have paired up for both treatments, earlier publishing the results from a Phase IIb study of BAN2401 in 856 patients with early Alzheimer´s disease that robustly demonstrated slowing of clinical decline with good tolerability after 18 months treatment.
The drug works by selectively targeting toxic aggregated forms of amyloid-beta in the brain, and shows a very strong reduction of aggregated amyloid-beta in the brain and effect on CSF biomarkers of neurodegeneration.