The Japan-based Eisai and Massachusetts-based Biogen have announced that experimental drug BAN2401 has demonstrated efficacy in slowing the progression of Alzheimer’s disease in Phase II trials.
The placebo-controlled, double blind, parallel group, randomised study involving 856 patients demonstrated the efficacy of the drug at 18 months in slowing the progression of Alzheimer’s in patients with mild cognitive impairment (MCI).
Patients who received the highest treatment dose of 10mg/kg bi-weekly demonstrated a statistically significant slowing of the disease in comparison with a placebo.
“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, at 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 drug demonstrated an acceptable tolerability profile throughout the 18 month period. The most common adverse events were infusion-related reactions and Amyloid Related Imaging Abnormalities (ARIA). Infusion related reactions were mild to moderate in severity in the majority of cases.
“The prospect of being able to offer meaningful disease-modifying therapies to individuals suffering from this terrible disease is both exciting and humbling,” said Dr Alfred Sandrock, 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 new data provides compelling evidence in support of the amyloid hypothesis as a therapeutic target in treating Alzheimer’s disease offering new hope for those suffering from the increasingly prevalent condition.