Bayer Presents Phase III Data for Iodine-124 PET Tracer: High Sensitivity Shown in Cardiac Amyloidosis Diagnosis

At the 2026 European Society of Cardiology Congress, Bayer presented results from the Phase III REVEAL study of its investigational PET radiotracer iodine-124 evuzamitide (I-124 evuzamitide). Data showed that the tracer met the study's primary endpoints in diagnostic sensitivity and specificity when used for imaging in patients with suspected cardiac amyloidosis.

The REVEAL study, sponsored by Brigham and Women's Hospital, is a multicenter, open-label, single-arm Phase III clinical trial conducted at 18 sites in the United States, enrolling 170 adult patients with suspected cardiac amyloidosis. Following a single intravenous injection of I-124 evuzamitide, subjects underwent cardiac and partial-body PET/CT imaging within 3 to 5 hours. Three independent blinded readers assessed the PET/CT images for the presence of tracer uptake in the heart without access to clinical data.

Cardiac amyloidosis is a progressive disease caused by the deposition of misfolded proteins in myocardial tissue, leading to thickening and stiffening of the heart muscle and impaired pumping function. Due to its complex clinical presentation, patients often require multiple tests to reach a definitive diagnosis, and delays, missed diagnoses, or misdiagnoses are not uncommon. I-124 evuzamitide is designed to bind to amyloid proteins, enabling direct imaging assessment of cardiac amyloid deposition.

Based on majority reads, defined as agreement between at least two readers, the tracer demonstrated a sensitivity of 94% and specificity of 86% for diagnosing cardiac amyloidosis. In disease subtype analyses, sensitivity was 96% and specificity 86% for transthyretin amyloidosis (ATTR), and sensitivity was 95% and specificity 86% for light chain amyloidosis (AL).

Regarding safety, among the 170 subjects who received I-124 evuzamitide, 55 (32.4%) experienced at least one treatment-emergent adverse event between Day 1 and Day 30. Of these, only one case of fatigue was considered related to the tracer. No deaths occurred during the study, and no discontinuations were attributed to adverse events related to the tracer.

I-124 evuzamitide remains investigational and has not been approved by any regulatory authority in any country or region for clinical indications. The tracer has previously received Breakthrough Therapy designation from the U.S. FDA and orphan drug designation for AL and ATTR amyloidosis in the United States and the European Union. Bayer stated that it plans to discuss the data and potential regulatory submissions with the FDA and other health authorities.