NAPLES, Fla., Jan. 15, 2025 (GLOBE NEWSWIRE) — Attralus, Inc., a clinical stage biopharmaceutical company developing transformative products to improve the lives of patients with systemic amyloidosis, and Brigham and Women’s Hospital, Boston, MA, are pleased to announce the enrollment of the first patient in the Research with 124I-EVuzamitide to Elucidate Cardiac AmyLoidosis (REVEAL) study – A Phase 3 clinical trial of the investigational diagnostic imaging agent, 124I-evuzamitide (AT-01), in patients with suspected cardiac amyloidosis. The trial is designed to determine the sensitivity and specificity of 124I-evuzamitide imaging to diagnose cardiac amyloidosis. “This study seeks to add significant value for patient care,” says Dr. Sharmila Dorbala, Principal Investigator and Sponsor of the REVEAL study. “124I-evuzamitide PET/CT imaging offers an exciting opportunity to noninvasively detect various types of amyloid deposition in the heart and other organs. As cardiac amyloidosis has high morbidity and mortality, early diagnosis is crucial. With effective FDA-approved treatments now available, a scan that can definitively detect amyloidosis or exclude it would be a major step forward to reduce diagnostic delays and improve patient outcomes.”
Tag: Attralus
Attralus Receives Breakthrough Therapy Designation for its Pan-Amyloid Diagnostic PET Imaging Candidate 124I-evuzamitide (AT-01) for Cardiac Amyloidosis
BURLINGAME, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) — Attralus, Inc., a clinical stage biopharmaceutical company developing transformative products to improve the lives of patients with systemic amyloidosis, today announced that its investigational diagnostic imaging agent drug, 124I-evuzamitide (AT-01), has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis. FDA granted BTD for 124I-evuzamitide (AT-01) based on clinical data from Attralus-sponsored and investigator-initiated studies evaluating the use of 124I-evuzamitide in patients with cardiac amyloidosis, representing experience in more than 200 trial participants.
Attralus Announces Publication of Two Studies Evaluating Iodine (124I) Evuzamitide (AT-01) using PET/CT in the Journal of American College of Cardiology (JACC CV Imaging)
124I-evuzamitide shown to be highly accurate for detection of cardiac amyloid across two independent investigator-initiated studies. 124I-evuzamitide detects multiple types of systemic amyloidosis. 124I-evuzamitide may be more sensitive than standard diagnostics, with cardiac uptake shown in ATTR patients who had […]
Positive New Data from Phase 1/2 Trial of AT-01 Presented at 2022 American College of Cardiology Annual Scientific Session
AT-01 is a first-in-class pan-amyloid imaging agent capable of detecting diverse types of amyloid Sensitivity in those with previously diagnosed cardiac disease was 100% in ATTR and 93% in AL Cardiac uptake was also observed in eleven patients who had […]
Attralus Announces Presentation of Clinical Data on AT-01, a Novel, Potential First-in-Class Diagnostic for Systemic Amyloidosis at the 2021 American College of Cardiology Annual Meeting
AT-01 detected cardiac amyloid in AL and ATTR patients with known cardiac disease with 95% sensitivity AT-01 detected cardiac amyloid in patients with AL or ATTR amyloid with normal levels of serum NT-proBNP AT-01 has the potential to distinguish AL […]