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FDA Giving Fast-Track Review to Alzheimer’s Candidate

Nerve cells illustration

(commonfund.nih.gov)

22 August 2016. U.S. Food and Drug Administration is giving an accelerated review to a candidate drug designed to treat Alzheimer’s disease. The drug, code-named AZD3293, is being developed as a joint project by drug makers AstraZeneca and Eli Lilly and Company.

AZD3293 is a type of small-molecule or low molecular weight drug known as an oral beta secretase cleaving enzyme, or BACE, inhibitor that aims to prevent the build-up of amyloid plaque toxicity. In Alzheimer’s disease, amyloid plaque develops in the brain, breaking down the ability of neurons or nerve cells to function efficiently, leading to death of neurons and shrinkage of brain tissue. Cognitive and memory loss are common symptoms of Alzheimer’s disease, which is the leading form of dementia, and the 6th leading cause of death in the U.S.

The drug acts by cleaving an amyloid precursor protein that releases and activates peptides inhibiting BACE, which in turn reduces toxicity of amyloid beta proteins making up the accumulating plaque. AstraZeneca first developed AZD3293 and began early-stage trials in 2012, which show the drug can reduce levels of amyloid beta proteins in cerebro-spinal fluid of patients with Alzheimer’s disease.

The alliance of AstraZeneca and Lilly began in September 2014 to take AZD3293 into intermediate and late-stage trials. As reported in Science & Enterprise, Lilly, in Indianapolis, is leading clinical development of AZD3293 in intermediate and late-phase trials among patients in the early stages of Alzheimer’s disease. The two companies are sharing commercialization of the drug, while AstraZeneca will be responsible for manufacturing. Lilly is paying AstraZeneca, based in London, up to $500 million in development and regulatory payments.

The companies’ first joint clinical trial is enrolling some 2,200 individuals experiencing gradual and progressive memory loss for more than 6 months. The study tests 2 dosage levels of AZD3293 against a placebo, taken once a day for 2 years. The trial’s main efficacy measure is a standard rating scale of memory functions, but the study is also tracking a number of other variables through questionnaires and scales, as well as PET scans and tests of proteins associated with Alzheimer’s in cerebro-spinal fluid.

FDA’s fast-track designation, as the name implies, offers accelerated review to treatments with a potential to address serious conditions or unmet medical needs. With fast-track status, FDA schedules more frequent meetings and provides more frequent correspondence. Fast-track status also provides for partial submissions and rolling review of a company’s new-drug or biological license applications, rather than waiting for the entire applications to be completed before submission.

In addition, Lilly and AstraZeneca are starting a new late-stage clinical trial of AZD3293, evaluating the drug among 1,900 individuals with probable or mild dementia caused by Alzheimer’s disease at 217 sites. The study is testing AZD3293 at 2 dosage levels against a placebo over 3 years. The randomly assigned placebo recipients, however, will start receiving AZD3293 at week 78, half-way through the study period.

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