INDIANAPOLIS — Eli Lilly and Company (NYSE: LLY) today announced it will begin enrolling patients this month in two separate but identical Phase III clinical trials of solanezumab(i), previously referred to as LY2062430, an anti-amyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer’s disease.
The trials, called EXPEDITION and EXPEDITION 2, will each include a treatment period that lasts 18 months and are expected to enroll a total of 2,000 patients age 55 and over from 16 countries.
In 2008, Lilly began enrolling patients in two Phase III clinical trials called IDENTITY and IDENTITY 2 for a different potential treatment for Alzheimer’s disease, a gamma-secretase inhibitor that also affects amyloid beta, which is believed to be one of the underlying pathologies of the disease. Patients or caregivers interested in learning how to enroll in either EXPEDITION trial or the IDENTITY trials should visit www.clinicaltrials.gov or call 1-877-CTLilly (1-877-285-4559). In combination, the EXPEDITION and IDENTITY trials will include approximately 4,600 patients with Alzheimer’s disease in over 30 countries around the world.
EXPEDITION and EXPEDITION 2 – EXPanding AlzhEimer’s Disease InvestigaTIONs
The EXPEDITION clinical trials are identical multicenter, randomized, double-blind, placebo-controlled trials. Patients enrolled in the trials will be randomized in a 1:1 ratio (500 patients in each trial arm) to receive intravenous infusions of either placebo or 400 mg of solanezumab once every four weeks. Patients who are taking currently available symptomatic treatments for Alzheimer’s disease can continue treatment during their participation in the EXPEDITION trials. The primary objective of both trials is to test whether solanezumab will slow the cognitive and functional decline of Alzheimer’s disease patients as compared with placebo. These outcomes will be analyzed using measures of the Alzheimer’s Disease Assessment Scale-Cognitive subscore (ADAS-COG(11)), which measures cognitive function with an emphasis on memory, and the Alzheimer’s Disease Cooperative Study – Activities of Daily Living scale (ADCS-ADL), which measures the ability to independently perform daily activities such as eating, bathing, and using the telephone. Secondary objectives of the trials include different clinical benefits as measured by several brain-scanning and biochemical biomarkers and ratings scales, and quality of life impact.
“Current therapies available to treat Alzheimer’s disease may help with symptoms, but they haven’t been proven to change the disease progression,” said Eric Siemers M.D., Medical Director, Alzheimer’s disease research for Eli Lilly and Company. “Biomarker results from a Phase II solanezumab trial give us hope that Lilly is on a path toward a treatment that may slow the rate of progression of Alzheimer’s disease.”
EXPEDITION will be conducted in Argentina, Brazil, Canada, Japan, and United States. EXPEDITION 2 will be conducted in Australia, France, Germany, Italy, Japan, Korea, Poland, Russia, Spain, Sweden, Taiwan, United Kingdom, and United States.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive neurodegenerative condition that is the most common cause of dementia, accounting for 60 to 80 percent of cases(ii). Estimates show that 6-8 percent of people over age 65 are affected by Alzheimer’s disease(iii), totaling approximately 5.3 million people in the United States alone(ii). Every 70 seconds, an American is developing Alzheimer’s disease(ii), and it is the sixth-leading cause of death in the United States(ii). The direct and indirect health care costs associated with Alzheimer’s disease and other dementias in the U.S. are estimated to be about $150 billion(ii). In 2005, the total cost worldwide of dementia, of which Alzheimer’s disease is the most common cause, was estimated at $315.4 billion(iv). The burden to caregivers and health care costs can increase dramatically in the late stages of Alzheimer’s disease, when patients cannot maintain independent function and are frequently bedridden(ii).
About Solanezumab
Alzheimer’s disease theory suggests that amyloid beta clumps together and eventually kills brain cells. Solanezumab binds specifically to soluble amyloid beta and thereby may draw the peptide away from the brain through the blood. In short-term clinical studies, solanezumab appeared to have dose-dependent effects on amyloid beta in blood and cerebrospinal fluid. The clinical studies to date have been too short to evaluate any potential delay in the progress of Alzheimer’s disease. To date, the only side effect experienced in clinical studies that appeared to be associated with solanezumab treatment has been mild chills consistent with an infusion reaction; other side effects reported in the Phase II study include nausea, vomiting, headache, back pain, and cough. For a more complete listing of potential side effects, prospective clinical trial participants should refer to the informed consent document.
About Lilly Biotech Efforts
Lilly is the 5th largest biopharmaceutical company in the world, with global biotech sales of more than $5.3 billion in 2008. Today, 40 percent of Lilly’s drug pipeline – and 50 percent of its late stage pipeline – is comprised of biotech compounds spanning potential treatment options for diabetes, cancer, Alzheimer’s disease, osteoporosis, multiple sclerosis and inflammation.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
This press release contains forward-looking statements about the potential of the investigational compound LY2062430 and reflects Lilly’s current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indication(s) anticipated by the company. There is also no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.
i. USAN (United States Adoptive Name council) adopted, INN (International Non-proprietary Name) pending
ii. “2009 Alzheimer’s Disease Facts and Figures.” Alzheimer’s Association. Available at: http://www.alz.org/national/documents/report_alzfactsfigures2009.pdf. May 13, 2009.
iii. Small, GW, Rabins, PV, Barry, PP, Buckholtz, NS, DeKosky, ST, Ferris, SH, Finkel, SI, Gwyther, LP, Khachaturian, ZS, Lebowitz, BD, McRae, TD, Morris, JC, Oakley, F, Schneider, LS, Streim, JE, Sunderland, T, Teri, LA, Tune, LE. Diagnosis and Treatment of Alzheimer’s Disease and Related Disorders: Consensus Statement of the American Association for Geriatric Psychiatry, the Alzheimer’s Association, and the American Geriatrics Society. JAMA 1997; 278: 1363-1371.
iv. Wimo A., Winblad B., Jonsson L. An estimate of the total worldwide societal costs of dementia in 2005 (2007) Alzheimer’s and Dementia, 3 (2), pp. 81-91