Phase II Data on Lilly's Antibody Show It Affects Amyloid Beta, a Protein Believed To Be Associated with Alzheimer...( Findings lead to decision to start P...),Health

Findings lead to decision to start Phase III pivotal study of LY2062430 in

2009

CHICAGO, July 30 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) today announced interim results of its Phase II study of LY2062430, an investigational anti-amyloid beta monoclonal antibody for the treatment of mild to moderate Alzheimer's disease. In this study, intravenously administered LY2062430 bound to the amyloid beta protein, resulting in increased amounts of amyloid beta in participants' blood and cerebrospinal fluid. These and other results suggest that by binding to soluble amyloid beta proteins, LY2062430 may begin to dissolve the amyloid plaques that are present in the brains of patients with Alzheimer's disease. While the precise cause of Alzheimer's disease is not known, it has been shown that people with this disorder have an excess of amyloid beta plaque in the brain, particularly in the regions associated with memory. It is theorized that decreasing the total amount of amyloid plaque and other forms of the amyloid beta protein in the brain may result in slowing of the disease progression. Importantly, LY2062430 was well tolerated with no evidence of treatment-related brain inflammation, bleeding or other side effects. The findings from this Phase II study were presented today at the Alzheimer's Association's 2008 International Conference on Alzheimer's Disease (ICAD) in Chicago.

In this randomized, controlled trial, researchers evaluated the safety and tolerability of LY2062430 administered intravenously in patients with Alzheimer's disease and in healthy volunteers. They assessed the effects of the antibody on levels of amyloid beta in the blood and cerebrospinal fluid, as an indirect measure of the effect of the antibody on amyloid beta present in the brain. Cerebrospinal fluid, which surrounds the brain and spinal cord, is thought to provide important biomarker data in addition to that obtained from
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