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

Thursday, July 31, 2008 General News
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CHICAGO, July 30 Eli Lilly and Company(NYSE: LLY) today announced interim results of its Phase II study ofLY2062430, an investigational anti-amyloid beta monoclonal antibody for thetreatment 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 andcerebrospinal fluid. These and other results suggest that by binding tosoluble amyloid beta proteins, LY2062430 may begin to dissolve the amyloidplaques 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 shownthat people with this disorder have an excess of amyloid beta plaque in thebrain, particularly in the regions associated with memory. It is theorizedthat decreasing the total amount of amyloid plaque and other forms of theamyloid beta protein in the brain may result in slowing of the diseaseprogression. Importantly, LY2062430 was well tolerated with no evidence oftreatment-related brain inflammation, bleeding or other side effects. Thefindings from this Phase II study were presented today at the Alzheimer'sAssociation's 2008 International Conference on Alzheimer's Disease (ICAD) inChicago.

In this randomized, controlled trial, researchers evaluated the safety andtolerability of LY2062430 administered intravenously in patients withAlzheimer's disease and in healthy volunteers. They assessed the effects ofthe 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 presentin the brain. Cerebrospinal fluid, which surrounds the brain and spinal cord,is thought to provide important biomarker data in addition to that obtainedfrom blood. Amyloid plaques, the pathological hallmark of Alzheimer'sdisease, are composed largely of aggregated amyloid beta proteins. Amyloidplaques or other types of the amyloid beta protein are thought ultimately todisrupt normal nerve cell function in the brain, leading to the dementia thatcharacterizes Alzheimer's disease.

"We are encouraged that in this study, we saw increased amyloid beta whichis thought to be bound to LY2062430, in both the blood and cerebrospinalfluid. We hypothesize that this effect may lead to reduced formation ofamyloid plaques in the brain after long-term treatment," said Eric Siemers,M.D., Medical Director, Alzheimer's disease research for Eli Lilly andCompany. "Alzheimer's disease is complex, and there's a real need for newtreatments that might be shown ultimately to slow disease progression. Inaddition to the biomarker results, we are particularly encouraged by thefinding that patients who received the monoclonal antibody treatment over 12weeks appeared to have no treatment-related side effects."

In this 12-week Phase II study, researchers gave 52 mild to moderateAlzheimer's disease patients infusions of placebo or LY2062430 in varyingdoses: 100mg or 400mg once a week, or 100mg or 400mg every four weeks.Alzheimer's disease symptom severity was also evaluated. In addition, 16volunteers each received a single dose of 100mg of LY2062430 or placebo. Forall study participants, safety assessments included magnetic resonance imaging(MRI) and cerebrospinal fluid examinations. A sub-study of 24 patients and 13volunteers underwent single photon emission tomography (SPECT) scanning usingan experimental tracer to assess levels of amyloid beta plaque in the brain.

The interim analysis showed that weekly infusions of LY2062430 up to 400mgper dose was well tolerated, with no side effects related to treatment. Anevaluation of MRI brain imaging and an assessment of cerebrospinal fluidshowed no evidence of brain inflammation or bleeding. As expected for a studyof this duration, no change in patients' cognitive scores was observed andt

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