Biogen Idec recently announced the results from a pre-specified interim analysis of PRIME, an ongoing Phase 1b randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of aducanumab (BIIB037) in patients with early or mild Alzheimer’s disease. The results were presented at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Nice, France.
Alzheimer’s disease is a neurodegenerative disorder where individuals initially experience memory loss and confusion that gradually leads to behavior and personality changes, a decline in cognitive abilities, and ultimately to severe loss of mental function. The disorder is characterized by the accumulation of amyloid proteins forming aggregates (amyloid plaques) in the brain and the loss of the connection between neurons responsible for memory and learning. The amyloid plaques are thought to play a crucial role in the development of the disease symptoms. There is currently no cure for Alzheimer’s disease.
Aducanumab is a therapeutic experimental drug against Alzheimer’s disease that corresponds to a human recombinant monoclonal antibody, which targets the aggregates of beta amyloid proteins, including soluble oligomers and insoluble fibrils in the amyloid plaques.
Researchers found that aducanumab treatment resulted in a dose- and time-dependent reduction in the levels of amyloid plaques in the brain of Alzheimer’s patients over a period of 54 weeks of treatment. Furthermore, the drug significantly slowed the patient’s cognitive and functional decline in comparison with patients under placebo treatment. In terms of safety, aducanumab was found to have an acceptable safety and tolerability profile, with the most frequent adverse events being amyloid-related imaging abnormalities like asymptomatic or mild edema (abnormal accumulation of fluid).
The research team concluded that aducanumab treatment is safe and induces a significant reduction in amyloid plaque levels and slows cognitive decline in patients with early (prodromal) or mild Alzheimer’s disease.
“This is the first time an investigational drug for Alzheimer’s disease has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease,” noted the senior vice president and chief medical officer at Biogen Idec, Dr. Alfred Sandrock in a news release. “Based on these results, we are advancing the aducanumab clinical program to Phase 3 with plans to initiate enrollment later this year.”