Attralus Begins Phase 3 Trial Enrollment for Cardiac Amyloidosis Diagnostic AT-01

Brigham and Women’s Hospital in Boston, in collaboration with Attralus, has initiated patient enrollment for the Phase 3 REVEAL study, focusing on the investigational diagnostic agent 124I-evuzamitide. This agent, also known as AT-01, is developed for use in patients suspected of having cardiac amyloidosis. The study aims to assess its efficacy as a non-invasive imaging method through PET scans, potentially offering a breakthrough in diagnosing this often under-recognized disease.

Cardiac amyloidosis, a condition where amyloid proteins deposit in heart tissues, is notoriously underdiagnosed due to vague symptoms and a lack of specific diagnostic tools. This condition is associated with significant morbidity and mortality rates, necessitating an urgent need for more effective diagnostic methods. The REVEAL study seeks to establish the sensitivity and specificity of 124I-evuzamitide PET imaging in detecting cardiac amyloidosis, potentially facilitating earlier diagnosis and treatment.

Sharmila Dorbala, the study's principal investigator, highlighted the potential of 124I-evuzamitide in transforming patient care. By enabling non-invasive detection of amyloid deposits across various organs, the agent could significantly reduce diagnostic delays. This advancement is crucial as timely diagnosis can lead to better outcomes for patients, especially with the availability of FDA-approved treatments for amyloidosis.

The U.S. Food and Drug Administration (FDA) has recognized the significance of this development by granting Breakthrough Therapy Designation to 124I-evuzamitide. This designation is based on promising clinical data involving over 200 patients in studies sponsored by Attralus. The agent has also received Orphan Drug Designations from both the FDA and the European Commission for managing ATTR and AL amyloidosis, underscoring its potential impact on patient care.

Spencer Guthrie, the Chief Operating Officer of Attralus, emphasized the critical nature of early diagnosis in cardiac amyloidosis, noting the current lack of FDA-approved diagnostic imaging options. He expressed commitment to expediting the availability of 124I-evuzamitide to the market, aiming to improve patient outcomes significantly.

The REVEAL study's primary objectives are to determine the sensitivity and specificity of 124I-evuzamitide PET/CT imaging in diagnosing cardiac amyloidosis. It plans to enroll up to 200 participants across the United States, including those with suspected ATTR, AL, or other cardiac amyloidosis types such as ApoA1 or ApoA4. The study also aims to evaluate the safety of a single intravenous dose of 124I-evuzamitide and explore its ability to detect amyloid deposits in organs beyond the heart.

124I-evuzamitide represents a novel approach to amyloidosis diagnostics. It employs an amyloid-specific radiotracer labeled with iodine-124, capable of detecting various types of systemic amyloidosis through PET/CT imaging. Clinical trials have shown its effectiveness in identifying amyloid deposits in major organs like the heart, liver, kidneys, and spleen.

Systemic amyloidosis is a group of rare diseases characterized by abnormal protein deposits in tissues and organs, often leading to severe and fatal outcomes. With a significant percentage of ATTR and AL patients experiencing cardiac involvement, there is a pressing need for more accurate and timely diagnostic methods. The development of 124I-evuzamitide could address this gap, enhancing the ability to diagnose and treat amyloidosis earlier.

Attralus, headquartered in Naples, Florida, is dedicated to advancing treatments and diagnostics for systemic amyloidosis. Their pioneering work in pan-amyloid removal therapeutics aims to remove toxic amyloid deposits, offering hope for treating and potentially reversing disease progression across all stages and types of systemic amyloidosis.