Eli Lilly and Company and AstraZeneca Initiate Pivotal Clinical Trial for Patients with Early Alzheimer's Disease
AZD3293, also known as LY3314814, has been shown in Phase I studies to reduce levels of amyloid-beta in the cerebro-spinal fluid of Alzheimer's patients and healthy volunteers. The progression of Alzheimer's disease is characterized by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of beta-amyloid. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.
The pivotal study will investigate the safety and efficacy of AZD3293/ LY3314814 compared with placebo in the treatment of early Alzheimer's disease.
"We're excited to take this important next step in Lilly's continuing efforts to make life better for so many people and families affected by Alzheimer's disease," said
AstraZeneca and Lilly announced an alliance earlier in 2014 for the development and commercialization of AZD3293/ LY3314814. Under the agreement, Lilly will lead clinical development, working with researchers from AstraZeneca's Neuroscience Innovative Medicines Unit, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization of the molecule and will share all future costs equally for development and commercialization, as well as net global revenues post-launch.
About the AMARANTH study
AMARANTH is a Phase II/III study that will further investigate the safety and efficacy of AZD3293/LY3314814 and test the hypothesis that it is a disease-modifying treatment for patients with early Alzheimer´s disease. Early Alzheimer's disease is defined as the continuum of patients with mild cognitive impairment (MCI) due to Alzheimer´s disease and patients diagnosed with mild Alzheimer´s dementia. The study, which has a two-year treatment period, aims to enroll more than 1500 patients in 15 countries.
About Alzheimer's disease
Alzheimer's disease, a fatal illness, is the most common form of dementia, accounting for 60 to 80 percent of dementia cases.  It continues to be one of the most significant health challenges facing
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.
This press release contains forward-looking statements about LY3314814/AZD3293 as a potential treatment for Alzheimer's disease and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. For further discussion of these and other risks and uncertainties, see Lilly's filings with the
 Alzheimer's Association. 2013 Alzheimer's disease facts and figures. Alzheimers Dement. 2013;9(2):208-245.
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