Lilly, AstraZeneca Kick Off Phase 2/3 Trial Of Alzheimer's Drug

AstraZeneca and its partner Eli Lilly & Co. announced that the companies’ Phase 2/3 trial of their drug candidate for the treatment of Alzheimer’s disease has begun with the enrollment of the first patient.

The companies are developing the drug candidate AZD3293, also known as LY3314814, as an oral beta secretase cleaving enzyme (BACE) inhibitor against Alzheimer’s disease. Early studies have shown the drug’s ability to lower levels of amyloid-beta in the cerebro-spinal fluid of patients with AD as well as healthy volunteers. As the enzyme BACE is linked with the development of beta-amyloid, inhibiting it is expected to hinder the formation of amyloid plaque that characterizes the disease and slows its progression.

The Phase 2/3 AMARANTH trial will assess the safety and efficacy of the drug compared to placebo in patients receiving treatment for early Alzheimer’s disease. The study will enroll over 1,500 patients in the EU and will be conducted over a two-year period.

Samantha Budd, VP and Head of Translational Science in AstraZeneca’s Neuroscience Innovative Medicines Unit, said, “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.”

Phyllis Ferrell, global brand development leader for Alzheimer’s disease at Lilly, said, “We’re excited to take this important next step… 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.”

Earlier this year AZ and Lilly announced their agreement to develop and market AZD3293. Lilly said it will take responsibility for leading clinical development while AstraZeneca will take the lead in manufacturing. The partners agreed to split the tab on the drug’s development and commercialization, as well as net global revenues after its approval and launch.