- 124I-evuzamitide (AT-01) PET/CT, the first pan-amyloid diagnostic imaging agent, demonstrated 100% sensitivity and specificity for the diagnosis of cardiac amyloidosis in patients suspected or diagnosed with cardiac amyloidosis in ATTR, AL, and other rare types of systemic amyloidosis.
- 124I-evuzamitide PET/CT demonstrated uptake in multiple organs with amyloid deposition utilizing cutoffs from automated quantification in patients with AL and ATTR amyloidosis.
- Phase 3 – REVEAL study with 124I-evuzamitide in patients with suspected cardiac amyloidosis is ongoing by Brigham and Women’s Hospital, Boston, MA.
- AT-05 (99mTc-p5+14), a radiotracer, designed for SPECT imaging, demonstrated high levels of sensitivity and specificity for detection of cardiac amyloid in AL and ATTR patients.
NAPLES, Fla., April 01, 2025 (GLOBE NEWSWIRE) — Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines and diagnostics to improve the lives of patients with systemic amyloidosis, announced three poster presentations (from four investigator-initiated trials), on the use of 124I-evuzamitide, the company’s pan-amyloid binding imaging agent in development for the diagnosis of cardiac amyloidosis, and one poster presentation of encouraging new clinical data from the University of Tennessee Graduate School of Medicine from an investigator-initiated trial on AT-05 (99mTc-p5+14) for the diagnosis of cardiac amyloid, at the 2025 American College of Cardiology (ACC) Annual Scientific Session held in Chicago, IL on March 29-April 1, 2025.
“Diagnosing patients early remains one of the biggest unmet needs for systemic amyloidosis patients, with many going years without an accurate diagnosis. Current diagnostic methods may not accurately detect early infiltration of amyloid deposits,” said Ahmad Masri, M.D., Assistant Professor of Medicine and the Director of Cardiac Amyloidosis and Hypertrophic Cardiomyopathy Centers at Oregon Health & Science University. “In our study, in 97 patients, we were able to show high levels of sensitivity and specificity for detection of cardiac amyloid in ATTR, AL, and other rare types of systemic amyloidosis patients, including in very early patients. We have been impressed by our results to date and are very much looking forward to the results of the ongoing Phase 3 REVEAL study in suspected cardiac amyloidosis patients. We are excited by the potential of 124I-evuzamitide to become a new standard of care for diagnosing systemic amyloidosis.”
“Detection and quantification of amyloid burden in the heart is an unmet clinical need for patients with diverse types of systemic amyloidosis,” said Jonathan Wall, Ph.D., Distinguished Professor, University of Tennessee Graduate School of Medicine. “AT-05 is a promising new reagent candidate for the facile detection of ATTR and AL cardiac amyloid using gamma imaging and may serve as a useful tool for the early detection of amyloidosis by community cardiologists, having the potential to be an invaluable tool to both detect early cardiac and extracardiac deposits.”
Poster Presentations –
- Poster 905-21: DIAGNOSTIC PERFORMANCE OF CARDIAC AND WHOLE-BODY 124I-EVUZAMITIDE (AT-01) PET/MRI IN SYSTEMIC AMYLOIDOSIS – Ahmad Masri
- Date: March 29, 2025, 11:18 – 11:25 a.m. CDT
- Presenter: Ahmad Masri, M.D., Oregon Health and Science University
- Highlights
- This study included 97 patients (57 had cardiac transthyretin amyloidosis, 20 had cardiac light chain amyloidosis, 3 had ApoA1 or ApoA4, 8 had systemic amyloidosis but no cardiac involvement, and 17 had no evidence of systemic amyloidosis).
- 124I-evuzamitide PET/MRI demonstrated 100% sensitivity and specificity in detecting cardiac amyloidosis. No false positive or false negative cases were observed.
- 124I-evuzamitide PET/MRI demonstrated uptake in multiple organs with amyloid deposition, including the kidneys, liver, spleen and lungs.
