Date: 2016-08-22
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: AstraZeneca (UK) Eli Lilly (USA - IN)
Product: AZD3293
Action
mechanism: BACE (beta-site APP-cleaving enzyme-1) inhibitor. AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease. AZD3293 is an oral, potent and selective small molecule inhibitor of BACE that has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers. AstraZeneca and Lilly announced an alliance in 2014 for the development and commercialization of AZD3293. Under the agreement, Lilly will lead clinical development, working with researchers from AstraZeneca's Research and Development Team, 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.
Disease: Alzheimer's disease
Therapeutic area: Neurodegenerative diseases
Country: Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Republic of Korea, Mexico, The Netherlands, Poland, Portugal, Russian Federation, Spain, Taiwan, UK, USA
Trial
details: The main purpose of this study is to evaluate the efficacy of the study drug known as LY3314814 in participants with mild Alzheimer's disease (AD) dementia. (NCT02783573 )
Latest
news: * On August 22, 2016, Eli Lilly and AstraZeneca announced they have received FDA Fast Track designation for the development program in Alzheimer's disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase 3 clinical trials. In addition to the continuing AMARANTH phase 2/3 study, Lilly and AstraZeneca have also announced the planned initiation of a second phase 3 trial for AZD3293. The trial, called DAYBREAK-ALZ, studies the safety and efficacy of AZD3293 in people with mild Alzheimer's dementia and began enrolling participants in the third quarter of 2016.
