AstraZeneca and Eli Lilly and Company (Lilly) announced enrolment of the first patient into AMARANTH, a phase II/III study of an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for 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 characterised 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.
Samantha Budd, vice president and head of translational science in AstraZeneca’s Neuroscience Innovative Medicines Unit 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. Together with Lilly, we have unique expertise that will allow us to evaluate the potential of AZD3293 as a treatment for Alzheimer’s patients.”
“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 Phyllis Ferrell, global brand development leader for Alzheimer’s disease at Lilly. “Our AstraZeneca partners share our determination to find answers for this condition that shatters lives. We’re pleased that the first patient enrollment in AMARANTH comes less than three months since we announced our alliance.”
AstraZeneca and Lilly announced an alliance earlier in 2014 for the development and commercialisation 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 commercialisation of the molecule and will share all future costs equally for development and commercialisation, as well as net global revenues post-launch.
AMARANTH is a phase II/III study that will further investigate the safety of AZD3293/LY3314814 and subsequently 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 enrol more than 1500 patients in 15 countries.