Successful Phase III A16 study of flortaucipir F 18 , a PET agent to predict Alzheimers disease diagnosis. - Eli Lilly.
Eli Lilly and Company and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced that a Phase III 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.
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 FDA in the near future.
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