Attralus Introduces First 124I-evuzamitide (AT-01) for Cardiac Amyloidosis

Attralus has introduced 124I-evuzamitide (AT-01), the first pan-amyloid diagnostic PET imaging candidate designed for cardiac amyloidosis. 

Recognised for its potential as a groundbreaking diagnostic tool, 124I-evuzamitide (AT-01) serves as a non-invasive, pan-amyloid PET imaging agent specifically developed to detect systemic amyloidosis. 

This innovative agent utilises the proprietary pan-amyloid binding peptide, labelled with iodine-124, to visualise various types of amyloid deposits across multiple organs—including the heart, kidney, liver, and spleen—using PET/CT imaging.

Clinical trials have demonstrated that 124I-evuzamitide is effective in detecting a wide range of amyloid deposits, including those associated with ATTR and AL, in major organs. 

Currently, no FDA-approved diagnostic imaging agents exist for cardiac amyloidosis, making the diagnosis of this condition a challenging and prolonged process. Many patients endure years without an accurate diagnosis, losing critical time for effective treatment.

Systemic amyloidosis refers to a collection of rare, progressive, and often fatal diseases caused by the accumulation of toxic amyloid deposits in tissues and organs due to abnormal protein misfolding. 

Cardiac involvement is prevalent among these conditions, with approximately 95 percent of ATTR and 75 percent of AL patients affected. Additionally, rarer forms of systemic amyloidosis, such as AA, AApoAI, and AApoAIV, also frequently involve the heart. 

Despite its severity, cardiac amyloidosis remains significantly underdiagnosed due to low awareness, non-specific symptoms, and the absence of disease-specific diagnostics. Consequently, there is a critical unmet need for more accurate and early diagnostic tools to improve patient outcomes.

124I-evuzamitide has been granted orphan drug designation by both the US FDA and the European Commission as a diagnostic tool for managing ATTR and AL amyloidosis.