Eli Lilly, AstraZeneca Launch Pivotal Clinical Trial For Early Alzheimer’s Disease Drug

Eli Lilly and Company and AstraZeneca announced the start of recruitment of patients for the Phase II/III AMARANTH clinical trial of an inhibitor of beta secretes cleaving enzyme (BACE), currently under development as a promising therapy for Alzheimer’s disease.

Alzheimer’s disease is characterized by two important pathological features — amyloid-β plaques and neurofibrillary tangles — and is the most frequent form of dementia, contributing for 60 to 80% of dementia cases. In the United States, Alzheimer’s is a major health challenge, since approximately 5 million Americans older than 65 years old are affected by the disease. Alzheimer’s is an economic and social burden not only for U.S. but also for many other developed nations. The U.S. alone incurs costs upwards of $200 billion dollars annually on the disease and it is estimated that the expenditure will increase to more than $1 trillion dollars by 2050. Therefore, there is an urgent need for the development of new treatments to decrease the progression of the disease and increase the delay of the debilitating associated-dementia.

The AMARANTH Phase II/III clinical trial will evaluate the safety and efficacy of oral AZD3293/LY3314814 against placebo and will assess if this drug can be designated as disease-modifying therapy for patients with early Alzheimer’s disease. The state of early Alzheimer’s disease includes patients with mild cognitive impairment (MCI) associated with Alzheimer’s disease and patients with mild Alzheimer’s dementia. This new study will include more than 1,500 patients in 15 countries, and the treatment will be for 2 years. In Phase I studies it was shown that the drug AZD3293 (LY3314814) reduced the amount of amyloid-beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy subjects. The increased levels of amyloid plaque in the brain contribute to the progression of Alzheimer’s disease. The beta secretes cleaving enzyme (BACE) is involved in the development of beta-amyloid, thus the inhibition of this enzyme can help avoid the formation of beta-amyloid plaques and ultimately decrease the progression of the disease.

“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, in a press release. “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.”

“There is a critical need for the development of 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,” said Samantha Budd, Vice President and Head of Translational Science in AstraZeneca’s Neuroscience Innovative Medicines Unit.

AstraZeneca and Lilly started the partnership for the development and commercialization of AZD3293/ LY3314814 in 2014. Lilly is responsible for conducting the clinical development together with the research team from AstraZeneca’s Unit of Neuroscience Innovative Medicines, whereas AstraZeneca is in charge of manufacturing the drug. Both companies will be responsible for commercialization of the drug and will divide the upcoming costs for development and commercialization and the future profits.