Lilly : Phase II Data on Lilly's Antibody Show It Affects Amyloid Beta, a Protein Believed To Be Associated with Alzheimer's Disease

July 30, 2008 - Eli Lilly and Company (NYSE: LLY) 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 blood. Amyloid plaques, the pathological hallmark of Alzheimer's disease, are composed largely of aggregated amyloid beta proteins. Amyloid plaques or other types of the amyloid beta protein are thought ultimately to disrupt normal nerve cell function in the brain, leading to the dementia that characterizes Alzheimer's disease... Eli Lilly's Press Release -

Lilly : First Phase III Trial for Treatment of Alzheimer's Disease

March 31, 2008 -- Eli Lilly and Company (NYSE: LLY) has announced the start of a Phase III clinical trial studying LY450139, an investigational gamma secretase inhibitor for the treatment of mild to moderate Alzheimer's disease. LY450139 is being tested to see if it can slow the progression associated with Alzheimer's disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Current Alzheimer's disease theory is that subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. By blocking gamma secretase, there is less amyloid beta formed, potentially slowing brain-cell death.

Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer's patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer's disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.

The IDENTITY Trial - Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY

IDENTITY is a randomized, double-blind, placebo-controlled trial that will be conducted in the U.S. and 21 additional countries. As part of IDENTITY, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study... Lilly's Press Release -