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.
Patients who are taking currently available symptomatic treatments for
Alzheimer's disease can continue treatment during their participation in
IDENTITY. Because the IDENTITY study also incorporates a "randomized
delayed start" design, even those subjects initially assigned to the
placebo arm of the study will be started on active LY450139 treatment
sometime before the end of the 21-month study period. Both the subjects and
investigators will be blinded to the exact timing of this delayed start of
study drug administration.
"Alzheimer's is a devastating disease that destroys brain cells,
affecting everything from a patient's memory to their work and social life.
Currently available medications treat the symptoms of Alzheimer's disease
but have not been shown to change its underlying progression, creating an
urgent unmet medical need. Today, we are proud to announce the start of the
IDENTITY clinical trial and hold hope that LY450139 will represent an
advance in the attempt to slow the progression of this fatal disease. We
encourage patients or their caregivers to review the enrollment criteria
for IDENTITY to see if they are eligible to participate," said Eric Siemers
M.D., Medical Director, Alzheimer's disease research for Eli Lilly and
Company.
Alzheimer's disease is a progressive neurodegenerative condition that
is the most common cause of dementia in patients over 65 years of age.
Estimates show that 6-8% of people over age 65 are affected by Alzheimer's
disease(1), totaling approximately 5 million people in the United States
alone(2). Every 72 seconds, an American is developing Alzheimer's
disease(3), and it is the seventh-leading cause of death in the United
States(4). The direct and indirect health care costs associated with
Alzheimer's disease in the U.S. are estimated to be about $150 billion(5).
In 2005, the total cost worldwide was estimated at $315.4 billion(6).
Given the aging population, without the availability of medicines that
delay or prevent the onset of Alzheimer's disease, the number of affected
people is expected to at least triple by the year 2050 in developed
nations(7). The average duration between onset of symptoms and death due to
complications of Alzheimer's disease is about 8-10 years(8). 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.
To more completely characterize the disease-modifying effects of
LY450139, a number of optional biomarker sub-studies will be available to
patients. These optional sub-studies will utilize new brain-scanning
techniques to determine the amount of amyloid beta plaque in the brain,
employ other, more established scanning techniques to examine brain
structure and function, and evaluate a number of additional biochemical
measures of Alzheimer's disease. By determining the effect of LY450139 on
these objective biomarkers, a more complete understanding of the effect of
LY450139 on underlying Alzheimer's disease pathology is possible.
About LY450139
LY450139 inhibits gamma secretase, an enzyme that cuts a protein,
creating a shorter, sticky protein called amyloid beta. Alzheimer's disease
theory suggests that some subtypes of amyloid beta clump together into
plaques that eventually kill off brain cells. Clinical studies have
examined the effect of LY450139 on amyloid beta in blood and cerebrospinal
fluid. The most frequently occurring side effects experienced in earlier
clinical studies with LY450139 include diarrhea, upset stomach, and
fatigue. For a more complete listing of potential side effects, prospective
clinical trial participants should refer to the informed consent document.
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 lilly. P-LLY
This press release contains forward-looking statements about the
potential of the investigational compound LY450139 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.
References
(1) 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 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.
(2) Alzheimer's Association. "2008 Alzheimer's Disease Facts and
Figures."
(3) American Public Health Association. "Mind Your Memory & Alzheimer's Disease!" Available at:
apha/membergroups/newsletters/sectionnewsletters/public_edu/ . Accessed March 21, 2008.
(4) Centers for Disease Control and Prevention. "National Vital
Statistics Reports."
(5) Alzheimer's Association. "2008 Alzheimer's Disease Facts and
Figures."
(6) Wimoa, Anders, Bengt Winblada, and Linus J. Jonssonb. An estimate of
the total worldwide societal costs of dementia in 2005. Alzheimer's &
Dementia (2007) 3:81-91.
(7) Population Division of the Department of Economic and Social Affairs
of the United Nations Secretariat.
"World population prospects: the 1996 revision." Washington, DC
(1998).
(8) National Institute on Aging. "Alzheimer's Disease Fact Sheet."
Available at
nia.nih/Alzheimers/Publications/adfact.htm. Accessed
March 21, 2008.
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