AstraZeneca and Eli Lilly and Co. have enrolled the first of more than 1,500 expected participants in study of a drug to fight early-onset Alzheimer's disease. The Phase II/III trial is expected to span 15 countries.
Phase I trials test a drug on a small group of people. In Phase II trials, a drug or treatment is given to a larger group of people to see whether it is effective and to further evaluate its safety. In Phase III trials, a drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it with commonly used treatments and collect information that will allow the drug or treatment to be used safely.
The Phase II/III study, known as AMARANTH, will look at the performance of an oral beta secretase cleaving enzyme (BACE) inhibitor known as AZD3293 or LY3314814. The progression of Alzheimer’s disease is marked by the accumulation of amyloid plaque in the brain, and in Phase I studies, the drug reduced levels of amyloid-beta in the cerebro-spinal fluid of people with Alzheimer’s as well as in healthy volunteers.
“We believe that BACE inhibitors have the potential to target one of the key drivers of this devastating disease,” Samantha Budd, vice president and head of translational science in AstraZeneca’s Neuroscience Innovative Medicines Unit, said in a statement.
Earlier this year, AstraZeneca and Lilly announced an alliance through which they will develop and commercialize AZD3293/LY3314814. Under the agreement, Lilly will lead clinical development, working with researchers from AstraZeneca’s Neuroscience Innovative Medicines Unit, and 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 commercialisation, as well as net global revenues post-launch.