Lilly Announces Initiation of Second Global Phase III Trial of Investigational Alzheimer's Diseas...( Pivotal Study to Provide Real-W...),Health

Pivotal Study to Provide Real-World Dosing Simulation of Lilly's

Gamma-Secretase Inhibitor

INDIANAPOLIS, Oct. 1 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) today announced it will begin enrolling patients in a second Phase III study of LY450139, a gamma-secretase inhibitor being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer's disease. The study, called IDENTITY 2, is expected to enroll 1,100 patients from 22 countries. When its results are evaluated along with findings from the first Phase III trial, IDENTITY, a more complete understanding of dosing strategies will be available from a truly global sample of patient data. Because of the study design, IDENTITY 2 will give additional insights into how LY450139 might be dosed in a real-world clinical setting. Patients or caregivers interested in learning more about how to enroll in either IDENTITY study are encouraged to visit http://www.lillytrials.com or call 1-877-CTLilly (1-877-285-4559).

While the precise cause of Alzheimer's disease is not known, current theory is that subtypes of amyloid beta, a type of sticky protein, clump together and eventually kill brain cells, causing the symptoms of the disease. LY450139 is a once-daily oral agent that is believed to slow the progression of Alzheimer's disease by inhibiting gamma secretase, an enzyme that can create amyloid beta. By blocking gamma secretase, there is less amyloid beta formed and potentially less brain cell death.

"We are proud to begin a second global trial of our gamma-secretase inhibitor in patients suffering from the devastating effects of Alzheimer's disease,"
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