Lilly Launches Its First Phase III Trial for Treatment of Alzheimer's Disease

Late-stage IDENTITY study of once-daily, oral agent is now enrolling patients

INDIANAPOLIS, March 31 /PRNewswire-FirstCall/ -- 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 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.
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).
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 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
forward-looking statements.
(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." Available at:
http://www.alz.org/national/documents/report_alzfactsfigures2008.pdf.
Accessed March 21, 2008.
(3) American Public Health Association. "Mind Your Memory & Alzheimer's
Disease!" Available at:
http://www.apha.org/membergroups/newsletters/sectionnewsletters/public_edu/fal
l07/alzheimer.htm. Accessed March 21, 2008. (4) Centers for Disease
Control and Prevention. "National Vital
Statistics Reports." Available at:
http://www.cdc.gov/nchs/data/nvsr/nvsr55/nvsr55_19.pdf. Accessed
March 21, 2008.
(5) Alzheimer's Association. "2008 Alzheimer's Disease Facts and
Figures." Available at:
http://www.alz.org/national/documents/report_alzfactsfigures2008.pdf.
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
(1998).
(8) National Institute on Aging. "Alzheimer's Disease Fact Sheet."
Available at
http://www.nia.nih.gov/Alzheimers/Publications/adfact.htm. Accessed
March 21, 2008.

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SOURCE Eli Lilly and Company

Christine Van Marter, Eli Lilly and Company, +1-317-651-1473