Lilly, AstraZeneca Alzheimer's Trial Advancing To Phase 3

Indianapolis, IN – Eli Lilly and AstraZeneca will continue to Phase 3 their Amaranth study of AZD3293 oral beta secretase cleaving enzyme (BACE) inhibitor as a potential treatment for early Alzheimer’s disease.

Amaranth is a Phase 2/3 study that is investigating the safety and efficacy of AZD3293 and testing the hypothesis that it is a disease-modifying treatment. The study, which has a two-year treatment period, aims to enroll approximately 2,200 patients in 14 countries.

An independent data monitoring committee recommended that the study continue without modification after conducting an interim safety analysis, which was not designed to review efficacy.

The Phase 3 trial, named Daybreak, will study the safety and efficacy of AZD3293 in people with mild Alzheimer’s dementia. The trial will begin enrolling participants in this year’s third quarter, according to the companies.

Under the terms of the alliance agreement reached in 2014, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments.

Now that AZD3293 has moved into Phase 3 testing, AstraZeneca will receive a milestone payment from Lilly resulting in a second-quarter charge of $100 million (pre-tax) to Lilly’s Generally Accepted Accounting Principles (GAAP) and non-GAAP research and development expense.

Lilly leads clinical development in conjunction with AstraZeneca researchers, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialization of the molecule and will share all future costs equally for development and commercialization, as well as net global revenues post-launch.

In Phase 1 studies AZD3293 reduced levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer’s and healthy volunteers, according to the drug companies. Alzheimer’s progression is characterized by the accumulation of amyloid plaque in the brain.

Inhibiting BACE, an enzyme associated with the development of amyloid beta, is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.

Of the 5.4 million Americans suffering from the disease in 2016, the Alzheimer’s Association reports that an estimated 5.2 million people are age 65 and older, and approximately 200,000 are under age 65. Those numbers are expected to escalate rapidly in coming years as the baby boom generation ages, potentially reaching an estimated 13.8 million people by 2050 barring the development of medical breakthroughs to prevent or cure the disease.

Worldwide, the U.K.-based Alzheimer’s Disease International estimates that 46 million people currently are living with dementia, a number that is expected to grow to more than 74 million in 2030 and 131 million in 2050. The total estimated worldwide cost of dementia in 2015 was $818 billion. By 2018, dementia will become a trillion dollar disease, rising to $2 trillion by 2030.

In the U.S., the Alzheimer’s Association estimates total payments for healthcare, long-term care and hospice in connection with Alzheimer’s and other forms of dementia will total $236 billion in 2016, rising to more than $1 trillion (in 2016 dollars) by 2050.

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