Bayer's PET Tracer Achieves Milestones in Phase III Amyloidosis Study

Bayer has announced successful results from a Phase III clinical trial evaluating its investigational PET tracer, iodine 124 evuzamitide, designed for diagnosing cardiac amyloidosis. The trial, named the REVEAL study, demonstrated significant sensitivity and specificity in identifying this condition through visual scan interpretation with PET/CT imaging. These results are anticipated to be discussed with the U.S. Food and Drug Administration (FDA) and other health authorities for potential regulatory submissions.

Cardiac amyloidosis is a serious disease characterized by the accumulation of amyloid proteins in heart tissue, leading to impaired cardiac function. The condition is often underdiagnosed, with symptom onset to diagnosis averaging 2 to 4 years. Accurate diagnostic tools are crucial, as early detection can prevent further organ damage. Currently, no single non-invasive test reliably detects and diagnoses cardiac amyloidosis.

Bayer's iodine 124 evuzamitide has previously been granted Breakthrough Therapy Designation and Orphan Drug status by the FDA and the European Medicines Agency for its role in diagnosing amyloidoses, specifically light-chain (AL) and transthyretin (ATTR) amyloidoses. These designations reflect its potential to meet unmet medical needs in diagnosing rare conditions.

The REVEAL study, conducted by Brigham and Women’s Hospital, was a multicenter, open-label trial involving 170 adults across 19 U.S. centers. Participants received a PET/CT scan following an intravenous dose of iodine 124 evuzamitide. The trial's primary goal was to compare the compound’s diagnostic performance against the standard of care, with secondary assessments focusing on AL and ATTR amyloidosis subtypes.

Dr. Sharmila Dorbala, principal investigator, highlighted the significance of these findings, noting the capabilities of a comprehensive diagnostic tool in distinguishing amyloid-related cardiac issues from other heart diseases. Moreover, the promising results could aid in tracking myocardial amyloid burden over time.

Bayer acquired iodine 124 evuzamitide, also known as AT-01, from Attralus, Inc. This acquisition is part of Bayer's strategy to expand its radiology portfolio, particularly in precision imaging for cardiovascular diseases and other serious conditions.

Bayer plans to present the full study results at an upcoming scientific congress, reinforcing its commitment to advancing diagnostic imaging technologies to enhance patient care.