Bioarctic announced that the company’s partner Eisai presented the latest data from the open-label extension of the Phase 2b study with the investigational BAN2401 in early Alzheimer’s disease. The preliminary results show, among other things, a continuous decrease in amyloid levels in the brain measured at three, six and twelve months with BAN2401 treatment in those patients who had previously received placebo. The data were presented at the Alzheimer’s Association International Conference 2020 (AAIC) on July 29.
The ongoing open-label extension study (OLE) includes 180 of the patients with early Alzheimer’s disease that were originally included in the Phase 2b study. The aim is to evaluate the long-term safety and tolerability of BAN2401 and brain amyloid levels measured by amyloid PET during continued treatment with BAN2401 at the highest dose used in the Phase 2b study. In the patients randomized to placebo in the Phase 2b study, a rapid decrease in amyloid levels was observed after three months of open-label treatment with BAN2401. After twelve months the observed effect was comparable to the results in patients randomized to start with this dose of BAN2401 in the Phase 2b study. The incidence of ARIA-E, a form of cerebral edema that occurs in patients treated for Alzheimer’s disease, remained low during treatment with BAN2401, and on a similar level as in the core Phase 2b study.
A Phase III clinical study, AHEAD 3-45, was recently initiated for preclinical Alzheimer’s disease (AD) patients.
Ban2401 is a humanized monoclonal antibody. BAN2401 selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates (protofibril) that are thought to contribute to the neurodegenerative process in Alzheimer’s disease. As such, BAN2401 may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
Eisai obtained the global rights to study, develop, manufacture and market BAN2401 for the treatment of Alzheimer’s disease pursuant to an agreement concluded with BioArctic in December 2007. In March 2014 Eisai and Biogen entered into a joint development and commercialization agreement for BAN2401 and the parties amended that agreement in October 2017.