Attralus Granted Breakthrough Therapy for 124I-evuzamitide in Cardiac Amyloidosis

Attralus, Inc., a biopharmaceutical company in the clinical stage, has announced that its diagnostic imaging agent, 124I-evuzamitide (AT-01), has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for use in positron emission tomography (PET) imaging of patients suspected to have cardiac amyloidosis. This designation, based on over 200 clinical trial participants, highlights the potential of 124I-evuzamitide to provide significant advancements in diagnosing this serious condition.

Breakthrough Therapy Designation is an FDA program designed to expedite the development and review of drugs intended to treat serious or life-threatening conditions. To qualify, preliminary clinical evidence must indicate that the drug may offer substantial improvements over existing therapies on one or more clinically significant endpoints. This designation allows for more intensive guidance from the FDA, organizational commitment, and eligibility for rolling and priority review of the Biologics License Application (BLA).

Dr. Gregory Bell, Chief Medical Officer of Attralus, expressed enthusiasm over the FDA’s decision, emphasizing the diagnostic challenges and lengthy processes faced by cardiac amyloidosis patients. There are currently no FDA-approved diagnostic imaging agents for this condition, leading to delayed diagnoses and significant loss of critical time for patients. Bell affirmed the company’s dedication to bringing 124I-evuzamitide to the market swiftly and working closely with the FDA to achieve this goal.

Systemic amyloidosis is a group of rare diseases caused by the accumulation of toxic amyloid deposits in tissues and organs, resulting from abnormal protein folding. These diseases are progressive, debilitating, and often fatal. Cardiac involvement is common in systemic amyloidosis, with around 95% of ATTR and 75% of AL patients experiencing cardiac issues. Other rare types, such as AA, AApoAI, and AApoAIV, also involve the heart. The condition is significantly underdiagnosed due to low awareness, non-specific symptoms, and a lack of disease-specific diagnostics. There is a substantial need for better diagnostic tools to enable earlier and more accurate diagnoses.

124I-evuzamitide is a non-invasive PET imaging agent designed to detect systemic amyloidosis. By utilizing a pan-amyloid binding peptide labeled with iodine-124, 124I-evuzamitide can image various types of amyloid deposits, including ATTR and AL, in major organs like the heart, kidney, liver, and spleen. It is the first diagnostic imaging agent to receive Breakthrough Therapy Designation for cardiac amyloidosis. The FDA and the European Commission have also granted orphan drug designations to 124I-evuzamitide for managing ATTR and AL amyloidosis. A Phase 3 study for patients with suspected cardiac amyloidosis is anticipated to commence in the first half of 2025.

Attralus is headquartered in Burlingame, California, and focuses on developing transformative products for systemic amyloidosis patients. The company’s proprietary pan-amyloid removal (PAR) therapeutics aim to bind and remove toxic amyloid deposits from organs and tissues. By targeting the underlying disease-causing pathology, PAR therapeutics have the potential to treat and reverse various types and stages of systemic amyloidosis. Founded by scientific experts in amyloidosis, Attralus is dedicated to improving patient outcomes through innovative treatments and diagnostics.