Phase 3 Study Update of Florbetaben for PET Imaging

Piramal Imaging SA announced positive first results from a Phase 3 study that showed that PET imaging with florbetaben reliably detects beta-Amyloid in the brain during life with great accuracy and thus shows value as a potential tool to aid in the diagnosis and assessment of Alzheimer's disease. The trial employed a study design comparing in vivo brain PET imaging with florbetaben to post-mortem analysis of the brain tissue.

All study endpoints were met, and the study showed that PET imaging with florbetaben provided reliable, reproducible results. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa=0.88).

This pivotal trial is the first to overlay MRI and PET data to accurately match florbetaben gray matter uptake with disease in six defined regions of the brain.  This was done to confirm that florbetaben binds to beta-Amyloid on both a regional (brain sections) and subject (whole brain) level. Based on a region-by-region comparison, florbetaben detected beta-Amyloid with a sensitivity of 77% and a specificity of 94% with substantial inter-reader agreement (kappa=0.66), significantly exceeding the pre-specified threshold, confirming the study hypotheses.

Florbetaben is an 18F-labeled PET tracer that specifically binds to deposition of beta-Amyloid. These depositions (plaques) consist of proteins that accumulate in the brain and are a pathological hallmark of Alzheimer's disease. As the aggregation of the beta-Amyloid protein in the brain is also a key target for new therapeutic treatments under development, florbetaben might also be able to support the development of these new treatment approaches.

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