Bayer has announced positive topline results from the phase 3 REVEAL study evaluating the investigational PET/CT radiotracer I 124 evuzamitide for the diagnosis of cardiac amyloidosis. The investigator-initiated study, led by Brigham and Women’s Hospital, successfully met its primary endpoints of sensitivity and specificity based on visual scan interpretation, highlighting the compound’s potential as a non-invasive diagnostic tool for the disease.
I 124 evuzamitide is an investigational PET radiotracer designed to assist clinicians in visualising amyloid protein deposits in the heart through PET/CT imaging. Bayer stated that detailed study findings will be presented at an upcoming scientific congress, while discussions with the US Food and Drug Administration (FDA) and other regulatory authorities regarding potential approval submissions are expected to follow.