Eli Lilly and Company and AstraZeneca, who previously partnered to study an investigational treatment for Alzheimer’s disease, have announced the enrollment of the first patient in the study, called AMARANTH. The Phase II/III study aims to evaluate the safety and efficacy of oral beta secretase cleaving enzyme (BACE) inhibitor, AZD3293.
The drug currently in study, known either as AZD3293 or LY3314814, is meant to block BACE, which is the an enzyme responsible for the development of Alzheimer’s Disease. By doing so, researchers expect a notable reduction in the formation of plaques of amyloid beta in the brain – one of the hallmarks of Alzheimer’s.
The phase II and III trials will evaluate the safety and efficacy of AZD3293/ LY3314814 compared to a placebo during a two-year treatment period of more than 1,500 Alzheimer’s patients, across 15 different countries. In addition, the two companies recently reported encouraging results from a Phase I study, conducted with both Alzheimer’s patients and healthy participants, demonstrating the effectiveness of the drug in reducing the levels of amyloid-beta in the cerebro-spinal fluid.
“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 the global brand development leader for Alzheimer’s disease at Lilly, Phyllis Ferrell. “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 fewer than three months since we announced our alliance.”
AstraZeneca and Lilly had signed a partnership agreement earlier this year, which mainly focused on developing and commercializing AZD3293/ LY3314814. The alliance stipulates Lilly to spearhead clinical development, while working with investigators from the Neuroscience Innovative Medicines Unit of AstraZeneca. The manufacturing, on the other hand, will be primarily handled by AstraZeneca. If the drug is approved, the commercialization will be held together by two companies, and will also share future costs for both development and commercialization, in addition to post-launch net global revenues.
“There is a critical need for the development of new medicines that can change the course of Alzheimer’s disease,” added the Vice President and Head of Translational Science in AstraZeneca’s Neuroscience Innovative Medicines Unit, Samantha Budd. “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.”