Brigham and Women’s Hospital has initiated enrollment for the Phase 3 REVEAL study of 124I-evuzamitide (AT-01), a diagnostic imaging agent for cardiac amyloidosis, in collaboration with Attralus. Attralus is developing 124I-evuzamitide as a non-invasive pan-amyloid PET imaging agent, aiming to address the unmet need for earlier and more accurate diagnosis of this underdiagnosed condition. The agent has received Breakthrough Therapy Designation from the FDA and orphan drug designations from both the FDA and European Commission.
This Phase 3 trial is crucial because it could significantly improve the diagnosis and management of cardiac amyloidosis, a condition with high morbidity and mortality. A reliable non-invasive diagnostic tool would allow earlier detection, facilitating timely intervention with recently approved treatments and potentially improving patient outcomes. This is particularly relevant given the current diagnostic challenges and delays that patients often experience.
The REVEAL study will enroll up to 200 participants with suspected cardiac amyloidosis, including various types such as ATTR, AL, ApoA1, and ApoA4. The study’s primary objective is to determine the sensitivity and specificity of 124I-evuzamitide PET/CT imaging for diagnosing cardiac amyloidosis. Secondary objectives include assessing the agent’s safety and exploring its ability to detect extracardiac organ involvement and differentiate between amyloid types. Enrollment is anticipated to complete by the end of 2025.
The successful completion and positive results from the REVEAL study could lead to the first FDA-approved diagnostic imaging agent specifically for cardiac amyloidosis. This would be a major advancement in the field, offering a much-needed tool for clinicians and significantly impacting patient care by enabling earlier diagnosis and treatment, ultimately improving prognosis and quality of life for individuals with this serious condition.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
