Lilly's Solanezumab Slows Down Alzheimer's Progression

Date: Oct-09-2012Solanezumab, an experimental Eli Lilly medication for Alzheimer's disease, slowed the rate of cognitive decline and memory loss by approximately 30% among patients in early stages of the disease.

Eli Lilly says the results of its latest clinical trial provides initial evidence that solanezumab may have an impact on the course of the disease.

Solanezumab is a monoclonal antibody, which Eli Lilly describes as a neuroprotector. Monoclonal antibodies are immune cells which are all clones of a unique parent cell.

Rachelle Doody, professor of Neurology and the Effie Marie Cain Chair in Alzheimer's Disease Research at Baylor College of Medicine, presented the results of the Phase 3, double-blind, placebo-controlled EXPEDITION study in patients with mild-to-moderate Alzheimer's disease. The presentation was given at the American Neurological Association meeting in Boston, Mass., USA.

Lilly informed that "This announcement follows the presentation of results from independent analyses of the EXPEDITION study data conducted by the Alzheimer's Disease Cooperative Study (ADCS)." (Dr. Doody is a member of the steering committee for the ADCS)

Doody explained that the study findings, which point towards targeting beta amyloid, a protein, should be investigated further in future studies.

Dr. Doody said:

"Alzheimer's disease research has been extremely challenging. The data results from the solanezumab Phase 3 trials were encouraging to the ADCS team. These results represent an important step for the medical, academic, and scientific communities in understanding brain amyloid as a target of AD therapies."

A previous Eli Lilly report, issued in August 2012, also showed that solanezumab slowed down cognitive decline and memory loss in Alzheimer's patients during the early stage of the disease. This latest study, by Doody, as well as experts from the University of California, San Diego, supported Lilly's August report claims.

Market experts believe Lilly may need to carry out a further study, confirming these results, before the FDA considers whether to accept a submission for drug approval.

According to Eli Lilly sources, the company has not yet met with FDA (Food and Drug Administration) officials to talk about what needs to be done next, if anything, before submitting the experimental medication for market approval.

Although solanezumab provides some benefits, they may not be enough to warrant approving the drug. Many describe the drug's impact as not much more than "a hint of activity".
About the EXPEDITION Trials
The EXPEDITION trials consisted of two Phase 3, double-blind, placebo-controlled solanezumab human studies involving patients with mild-to-moderate Alzheimer's disease. Participants in 16 different countries were involved.

EXPEDITION1 and EXPEDITION2 had the same design: they recruited patients aged from 55 to 94 years. 1,012 participants enrolled in EXPEDITION 1 and 1,040 in the second. Patients were administered either solanezumab intravenously (400mg) or placebo - doses were given once every four weeks for a total of 18 months. In both trials, patients were allowed to stay on stable standard of care throughout the 18 months. Over 85% of the participants were on an acetycholinesterase inhibitor and / or memantine.
Alzheimer's disease
Alzheimer's disease is the most common type of dementia - it is a progressive neurologic disease of the brain. Patients experience progressively worsening memory, reasoning, and other aspects of cognition. Symptoms eventually become so severe that the patient is unable to look after himself/herself.

Nobody completely knows what exactly causes the disease. Israeli scientists believe that fly neurons could reveal the root of Alzheimer's disease.

During the disease's progression, plaques and tangles develop within the structure of the brain, resulting in the death of brain cells. Alzheimer's patients have abnormally low levels of some essential neurotransmitters; brain chemical which are involved in transmitting message within the brain.

To date, there are no medications or treatments that have clearly been demonstrated to effectively slow down the disease. Neuroscientists from the USA and China managed to reverse Alzheimer's-like signs and symptoms in animals by using some anti-cancer medications with untested compounds. The only treatment options at the moment are those that alleviate some of Alzheimer's symptoms.

There are approximately 35.6 million individuals with dementia globally, and 7.7 million new cases every year - one every four seconds. Market analysts predict that by 2050, the number of people living with dementia will rise to 115 million by the middle of this century.

Estimates on how many Americans currently have Alzheimer's disease vary considerably. According to the Alzheimer's association, there are about 5.4 million.

Written by Christian Nordvist

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today
Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.