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While the precise cause of Alzheimer's disease is not known, currenttheory is that subtypes of amyloid beta, a type of sticky protein, clumptogether and eventually kill brain cells, causing the symptoms of the disease.LY450139 is a once-daily oral agent that is believed to slow the progressionof Alzheimer's disease by inhibiting gamma secretase, an enzyme that cancreate amyloid beta. By blocking gamma secretase, there is less amyloid betaformed and potentially less brain cell death.
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"We are proud to begin a second global trial of our gamma-secretaseinhibitor in patients suffering from the devastating effects of Alzheimer'sdisease," said Eric Siemers, M.D., medical director, Alzheimer's diseaseresearch for Eli Lilly and Company. "IDENTITY 2 is a study that we believewill give us additional insights into how LY450139 might best be given topatients in real clinical situations, information that is often not learneduntil a medicine is approved and prescribed in clinical practice. The start ofthis key trial is an important landmark for Lilly, especially considering theongoing IDENTITY study, and the planned initiation of a Phase III study of ourother investigational treatment for Alzheimer's disease, an anti-amyloid betamonoclonal antibody, next year. Lilly has a strong commitment to Alzheimer'sdisease -- we have an extensive early research program and are the onlypharmaceutical company with two of its own Alzheimer's disease molecules inactive late-stage development."
IDENTITY 2 - Interrupting Alzheimer's Dementia by EvaluatiNg Treatment ofAmyloId PaThologY
IDENTITY 2 is expected to enroll 1,100 patients, and includes a treatmentperiod of approximately 21 months. An open-label extension will be availableto all participants completing the study. In IDENTITY 2, patients will berandomized to receive either 140 mg of LY450139 or placebo. Patients who aretaking currently available symptomatic treatments for Alzheimer's disease cancontinue treatment during their participation in IDENTITY 2. The study alsoincorporates a "randomized delayed start" design, which means that even thosesubjects initially assigned to the placebo arm will be started on LY450139sometime before the end of the 21-month study period. Also, becauseinvestigators have the flexibility to lower and then increase the dose basedon patient tolerability, IDENTITY 2 is designed to provide a more real-worldsimulation of how LY450139 could be used in clinical practice.
The primary endpoints for IDENTITY 2 are the same co-primary endpoints asthe IDENTITY trial: Alzheimer's Disease Assessment Scale-Cognition (ADAS-cog),which measures cognitive function with an emphasis on memory, and theAlzheimer's Disease Cooperative Study - Activities of Daily Living scale(ADCS-ADL), which measures the ability to independently perform dailyactivities such as eating, bathing, and using the telephone. A number ofoptional biomarker substudies will be available to patients that will utilizebrain-scanning and biochemical techniques to detect markers of Alzheimer'sdisease.
Alzheimer's disease is a progressive neurodegenerative condition that isthe most common cause of dementia, accounting for 60 to 80 percent ofcases(1). Estimates show that 6-8 percent of people over age 65 are affectedby Alzheimer's disease(2), totaling approximately 5.5 million people in theUnited States alone(3). Every 72 seconds, an American is developingAlzheimer's disease(4), and it is the seventh-leading cause of death in theUnited States(5). The direct and indirect health care costs associated withAlzheimer's disease and other dementias in the U.S. are estimated to be about$150 billion(6). In 2005, the total cost worldwide of dementia, of whichAlzheimer's disease is the most common cause, was estimated at $315.4billion(7). The burden to caregivers and health care costs can increasedramatically in the late stages of Alzheimer's disease, when patients cannotmaintain independent function and are frequently bedridden(8).
About LY450139
LY450139 inhibits gamma secretase, an enzyme that cuts a protein, creatinga shorter, sticky protein called amyloid beta. Alzheimer's disease theorysuggests that some subtypes of amyloid beta clump together and eventually killbrain cells. Clinical studies have examined the effect of LY450139 on amyloidbeta in blood and cerebrospinal fluid. The most frequently occurring sideeffects experienced in earlier clinical studies with LY450139 includediarrhea, upset stomach, and fatigue. For a more complete listing of potentialside effects, prospective clinical trial participants should refer to theinformed consent document.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growingportfolio of first-in-class and best-in-class pharmaceutical products byapplying the latest research from its own worldwide laboratories and fromcollaborations with eminent scientific organizations. Headquartered inIndianapolis, Ind., Lilly provides answers -- through medicines andinformation -- for some of the world's most urgent medical needs. Additionalinformation about Lilly is available at www.lilly.com. P-LLY
This press release contains forward-looking statements about the potentialof the investigational compound LY450139 and reflects Lilly's current beliefs.However, as with any pharmaceutical product under development, there aresubstantial risks and uncertainties in the process of development andregulatory review. There is no guarantee that the product will receiveregulatory approvals, or that the regulatory approval will be for theindication(s) anticipated by the company. There is also no guarantee that theproduct will prove to be commercially successful. For further discussion ofthese and other risks and uncertainties, see Lilly's filing with the UnitedStates Securities and Exchange Commission. Lilly undertakes no duty to updateforward-looking statements.
(1) Alzheimer's Association. "2008 Alzheimer's Disease Facts and Figures."Available at:http://www.alz.org/national/documents/report_alzfactsfigures2008.pdf. AccessedSeptember 22, 2008.
(2) 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 RelatedDisorders: Consensus Statement of the American Association for GeriatricPsychiatry, the Alzheimer's Association, and the American Geriatrics Society.JAMA 1997; 278: 1363-1371.
(3) 2008 Alzheimer's Disease Facts and Figures. Alzheimer's Association.Available at:http://www.alz.org/national/documents/report_alzfactsfigures2008.pdf. AccessedSeptember 22, 2008.
(4) "Mind Your Memory & Alzheimer's Disease!" American Public HealthAssociation. Available at:http://www.apha.org/membergroups/newsletters/sectionnewsletters/public_edu/fall07/alzheimer.htm. Accessed September 22, 2008.
(5) "National Vital Statistics Report." Center for Disease Control.Available at: http://www.cdc.gov/nchs/data/nvsr/nvsr56/nvsr56_10.pdf. AccessedSeptember 22, 2008.
(6) "2008 Alzheimer's Disease Facts and Figures." Alzheimer's Association.Available at:http://www.alz.org/national/documents/report_alzfactsfigures2008.pdf.September 22, 2008.
(7) Wimoa, Anders, Bengt Winblada, and Linus J. Jonssonb. An estimate ofthe total worldwide societal costs of dementia in 2005. Alzheimer's & Dementia(2007) 3:81-91.
(8) 2008 Alzheimer's Disease Facts and Figures. Alzheimer's Association.Available at:http://www.alz.org/national/documents/report_alzfactsfigures2008.pdf. AccessedSeptember 22, 2008.
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SOURCE Eli Lilly and Company
