SAN FRANCISCO, Aug. 08, 2022 (GLOBE NEWSWIRE) — Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for 124I-AT-01 (iodine (I-124) evuzamitide) as a diagnostic for the management of transthyretin amyloidosis (ATTR). 124I-AT-01 utilizes the Company’s pan-amyloid binding peptide as an amyloid-specific imaging agent to detect and quantify amyloid in multiple types of systemic amyloidosis and key organs involved by PET/CT imaging.
“124I-AT-01 has the potential to be the first amyloid-specific imaging agent designed to detect amyloid across key organs, including the heart,” said Gregory Bell, MD, Chief Medical Officer at Attralus. “AT-01 has the potential to become an essential tool not only to streamline diagnosis, but also to provide a comprehensive assessment of disease burden and a means to monitor disease progression in patients with ATTR amyloidosis.”
The Phase 1/2 trial, conducted by the University of Tennessee Medical Center, evaluated the ability of 124I-AT-01 to detect amyloid deposits by PET/CT imaging in patients with diverse forms of systemic amyloidosis, including ATTR. The trial enrolled a total of 57 subjects including 20 patients with ATTR amyloidosis. Additional data on AT-01 will be presented at the 2022 International Symposium on Amyloidosis scheduled for September 4-8.
Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use,
BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.