AstraZeneca and Eli Lilly have started enrolling patients in AMARANTH Phase II/III trial of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor, currently being developed to treat Alzheimer’s disease (AD).
Around 1,500 patients in 15 countries will be enrolled in the trial, which will evaluate the safety and efficacy of AZD3293/LY3314814 compared with placebo in the treatment of early AD.
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Results from the Phase I trials showed that AZD3293, also called as LY3314814, reduced levels of amyloid-beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers.
Alzheimer’s disease progression is characterised by the accumulation of amyloid plaque in the brain.
Inhibiting BACE, an enzyme associated with the development of beta-amyloid, is expected to prevent the formation of amyloid plaque and slow the progression of the disease.
AstraZeneca Neuroscience Innovative Medicines Unit vice-president and head of Translational Science Samantha Budd said: "There is a critical need to develop new medicines that can change the course of Alzheimer’s disease.
"We believe that BACE inhibitors have the potential to target one of the key drivers of this devastating disease."
Earlier this year, the two firms have entered into an alliance to develop and commercialize AZD3293/LY3314814.
As part of that deal, Lilly will lead clinical development, working with researchers from AstraZeneca’s Neuroscience Innovative Medicines Unit, and AstraZeneca will be responsible for manufacturing.
Under this deal, the firms will take joint responsibility for commercialisation of the molecule and will share all future costs equally for development and commercialisation, as well as net global revenues post-launch.
