Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced that a Phase 3 study of flortaucipir F 18, a Positron Emission Tomography (PET) imaging agent, met its two primary endpoints, defined as predicting brain tau pathology and predicting Alzheimer's disease diagnosis.
The study, referred to as A16, enrolled a total of 156 end-of-life patients with dementia, mild cognitive impairment, or normal cognition who underwent flortaucipir PET imaging. Subsequently, 67 of these patients were evaluated post-mortem. The study met pre-specified endpoints with flortaucipir demonstrating statistically significant sensitivity and specificity for detecting tau pathology of Braak Stage V/VI, a pathological staging scale for tau neurofibrillary tangles. Flortaucipir also demonstrated statistically significant sensitivity and specificity for detecting a high level of total Alzheimer's disease neuropathologic change (combining both tau and amyloid plaque densities), using the National Institute on Aging and Alzheimer's Association (NIA-AA) neuropathology criteria.
"These encouraging results are a major advance in our ability to image the pathology of Alzheimer's disease," said Mark Mintun, M.D., vice president of Lilly's pain and neurodegeneration research and development. "We hope this and other advances in the field can help speed development of treatments, as well as provide more diagnostic information for doctors taking care of patients suspected of having Alzheimer's."
The company plans to disclose more detailed study results in October at the Clinical Trials on Alzheimer's Disease meeting in Barcelona, and will discuss these findings and potential next steps with the U.S. Food and Drug Administration in the near future.
About Alzheimer's Disease
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition.1 Dementia due to Alzheimer's disease is the most common form of dementia, accounting for 60 to 80 percent of all cases.2 There are currently an estimated 50 million people living with dementia around the world, with numbers expected to increase to nearly 75 million by 2030 and 132 million by 2050. Almost 10 million new cases of dementia are diagnosed each year worldwide, implying one new case every 3.2 seconds. The current total annual societal and economic estimated cost of dementia is $818 billion USD worldwide and this year may rise above a trillion USD.3