Bayer issues positive report for cardiac amyloidosis radiotracer

Bayer has announced positive topline results from the phase III REVEAL study evaluating its investigational PET/CT radiotracer iodine-124 (I-124) evuzamitide for the diagnosis of cardiac amyloidosis.

Cardiac amyloidosis is also known as "stiff heart syndrome," where abnormal proteins build up in the heart. The study, an investigator-initiated trial by Brigham and Women's Hospital in Boston, met its primary endpoints of sensitivity and specificity for diagnosing cardiac amyloidosis based on visual scan interpretation, according to the company. 

The multicenter, open-label study evaluated 170 adults with suspected cardiac amyloidosis at 19 U.S. centers. I-124 evuzamitide, also known as AT-01, previously received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for PET imaging in patients with suspected or known cardiac amyloidosis, as well as orphan drug status for light-chain amyloidosis and transthyretin amyloidosis in the U.S. and EU, Bayer said.

Bayer plans to present the complete results at an upcoming scientific congress. I-124 evuzamitide has not been approved by any health authority; however, the company plans to file for regulatory approval with the FDA and other health authorities, according to the announcement.