Late-stage IDENTITY study of once-daily, oral agent is now enrolling
INDIANAPOLIS, March 31 /CNW/ -- Eli Lilly and Company (NYSE: LLY) has
announced today 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
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
"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.
Additional information regarding the IDENTITY trial, including global
recruitment sites, may be found by visiting www.clinicaltrials.gov or
www.lillytrials.com, or by calling 1-877-CTLilly (1-877-285-4559).
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.
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. 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
(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:
(2) Alzheimer's Association. "2008 Alzheimer's Disease Facts and
Figures." Available at:
Accessed March 21, 2008.
(3) American Public Health Association. "Mind Your Memory & Alzheimer's
Disease!" Available at:
l07/alzheimer.htm. Accessed March 21, 2008.
(4) Centers for Disease Control and Prevention. "National Vital
Statistics Reports." Available at:
March 21, 2008.
(5) Alzheimer's Association. "2008 Alzheimer's Disease Facts and
Figures." Available at:
Accessed March 21, 2008.
(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
(8) National Institute on Aging. "Alzheimer's Disease Fact Sheet."
March 21, 2008.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
For further information:
For further information: Christine Van Marter, Eli Lilly and Company,