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A phase 3 study to investigate a humanized monoclonal antibody as a potential therapy for mild cognitive impairment from Alzheimer’s disease (AD)began this month. The open-label extension study of BAN2401 (Eisai; Woodcliff Lake, NJ) includes patients previously enrolled in a phase 2b study of BAN 2401 at a dose of 10 mg every 2 weeks. BAN2401 is targets the toxic, aggregated forms of amyloid-ß in the brain.
In that phase 2b study of 856 patients with early AD, treatment with BAN2401 reduced of amyloid-ß and slowed cognitive decline. Decreases in neurodegenerative biomarkers in cerebrospinal fluid such as total-tau, phospho-tau, neurogranin, and neurofilament light were also seen.
Researchers are exploring a phase 3 study of BAN2401 with patients in earlier stages of the disease than previously studied. “I am pleased to notice how effectively our partner Eisai is progressing the clinical development of BAN2401,” said Gunilla Osswald, PhD, CEO, BioArctic. “It is also exciting that Eisai is exploring the possibilities to study BAN2401 in even earlier stages of Alzheimer’s disease.”