Japan-based Eisai and Biogen have reported positive topline results from the Phase II Study 201 trial of BAN2401 for the treatment of early Alzheimer's disease (AD).
Study 201 enrolled 856 patients with mild cognitive impairment (MCI) due to AD or mild Alzheimer's dementia, both of which are collectively known as early Alzheimer’s disease, with confirmed amyloid pathology in the brain.
The placebo-controlled, double-blind, parallel-group, randomised trial examined the efficacy of BAN2401 at 18 months by predefined conventional statistics on Alzheimer’s Disease Composite Score (ADCOMS).
As part of the trial, patients were randomised to receive five dose regimens, including 2.5mg/kg biweekly, 5mg/kg monthly, 5mg/kg biweekly, 10mg/kg monthly and 10mg/kg biweekly, or placebo to the patients.
The newly released results have showed a statistically significant reduction in disease progression on the ADCOMS after 18 months of treatment in patients receiving the highest treatment dose of 10mg/kg biweekly as compared to placebo.
It was also found that BAN2401 was able to reduce the amount of amyloid accumulated in the brain.
In addition, BAN2401 showed an acceptable tolerability profile during the 18 months of study drug administration.
Eisai Neurology Business Group chief clinical officer and chief medical officer Lynn Kramer said: “This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis.
“We will discuss these very encouraging results with regulatory authorities to determine the best path forward.”
BAN2401 is a humanised monoclonal antibody for AD that is currently being developed by Eisai and BioArctic under a strategic research alliance.