February 8, 2023 — Life Molecular Imaging (LMI) announced that the first patient has been imaged with [18F]florbetaben in the CArdiag Phase 3 clinical study. This is an open-label, multi-center, non-randomized pivotal Phase 3 study to evaluate the diagnostic efficacy of [18F]florbetaben Positron Emission Tomography (PET) imaging to diagnose cardiac AL amyloidosis in patients with suspected cardiac amyloidosis.
The CArdiag Phase 3 clinical program will be performed in Germany, Spain, UK and US – and will enroll approximately 200 patients globally. The primary objective is to determine the sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis compared to standard of care clinical diagnosis.
[18F]florbetaben PET is validated and approved to detect neuritic beta amyloid plaques in the brain and available via a global supply network marketed as Neuraceq®. Initial clinical data showed that amyloid deposits of other origin in the heart, such as AL amyloid and transthyretin (TTR) amyloid, can also be detected. Based on these data, the European Commission and the U.S. Food and Drug Administration granted orphan drug designation to [18F]florbetaben in 2020 as a diagnostic tool for AL amyloidosis. The detection of amyloid deposits in the heart will be further investigated and validated in the current Phase 3 trial. Exploratory analyses will evaluate the possibility for a differential diagnosis between the two main types (AL and ATTR) of cardiac amyloidosis by [18F]florbetaben PET.
“Expanding the indication for our amyloid PET tracer from detecting ß-amyloid deposits in the brain to detecting amyloid deposits in the heart in patients with cardiac amyloidosis will allow us to support an earlier diagnosis of this rare and life-threatening disease”, said Dr. Ludger Dinkelborg, CEO of Life Molecular Imaging. “We are proud to announce the start of this Phase 3 study, which marks another milestone on our vision to reduce the burden of disease by improving early diagnosis and characterization of chronic and life-threatening diseases.”
“Cardiac AL amyloidosis is a progressive and life-threatening disease, and its diagnosis and treatment are challenging”, said Dr. Andrew Stephens, MD, PhD, CMO of Life Molecular Imaging. “[18F]florbetaben PET imaging of patients with suspected cardiac amyloidosis has the potential to become an important tool to simplify and shorten the time to diagnosis, providing earlier and appropriate access to therapy and improved monitoring of such interventions.”
For more information: https://life-mi.com/