BAN2401, a humanised monoclonal antibody that selectively binds to and eliminates soluble amyloid-β aggregates, has been shown to have statistically significant effects in reducing the amount of amyloid in early Alzheimer’s disease (AD) patient brains, as well as slowing the decline in clinical outcome measures of cognition and function. The pioneering results of this Phase II clinical trial were presented at the Alzheimer’s Association International Conference (AAIC) 2018 on the 25th July 2018.
The double-blind, placebo-controlled, randomised study of 856 patients with early AD and positive amyloid pathology evaluated the efficacy of BAN2401 at 18 months using conventional statistics on AD composite scores (ADCOMS). Patients were randomised to five regimens: placebo; 2.5 mg/kg biweekly; 5.0 mg/kg monthly; 5.0 mg/kg biweekly; 10.0 mg/kg monthly; or 10.0 mg/kg biweekly. Top-line results showed that after 18 months, patients receiving BAN2401 10.0 mg/kg biweekly had a statistically significant slowing of disease progression with regard to ADCOMS compared to placebo. Results for amyloid PET analysis at the same dose were also found to be statistically significant. BAN2401 was found to be tolerated by patients; the most common adverse events were infusion-related reactions and amyloid-related imaging abnormalities.
Commenting on the significance of these results, Dr Lynn Kramer, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai Co., Ltd., Tokyo, Japan, 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”. He went on to comment on the future progression of these remarkable results: “We will discuss these very encouraging results with regulatory authorities to determine the best path forward. We continue to work towards the goal of delivering BAN2401 to patients and healthcare professionals as early as possible.”