Positive topline results from the Phase II clinical study assessing an anti-amyloid beta protofibril antibody in patients with early Alzheimer’s disease have been revealed by Eisai and Biogen.
Alzheimer's
Statistical significance was achieved on set predefined endpoints evaluating efficacy at 18 months, according to the companies. It was revealed that BAN2401 was effective at slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and at reducing amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography).
“The 18-month results of the BAN2401 trial are impressive and provide important support for the amyloid hypothesis,” commented Dr Jeff Cummings, founding director, Cleveland Clinic Lou Ruvo Center for Brain Health. “I look forward to seeing the full data set shared with the broader Alzheimer’s community as we advance against this devastating disease.”
“This is the first late-stage anti-amyloid antibody study to successfully achieve statistically significant results at 18 months, further validating the amyloid hypothesis,” said Dr Lynn Kramer, chief clinical officer and chief medical officer, Neurology Business Group, Eisai. “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.”
“The prospect of being able to offer meaningful disease-modifying therapies to individuals suffering from this terrible disease is both exciting and humbling,” added Dr Alfred Sandrock, PhD, executive vice president and chief medical officer at Biogen. “These BAN2401 18-month data offer important insights in the investigation of potential treatment options for patients with Alzheimer’s disease and underscores that neurodegenerative diseases may not be as intractable as they once seemed.”
The placebo-controlled, double-blind, parallel-group, randomised study included 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s dementia with confirmed amyloid pathology in the brain. Patients were randomised to five dose regimens, 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly and 10 mg/kg biweekly, or placebo.
Topline results of the final analysis of the study demonstrated a statistically significant slowing of disease progression on the key clinical endpoint (ADCOMS) after 18 months of treatment in patients receiving the highest treatment dose (10 mg/kg biweekly) as compared to placebo.