PET Imaging Agent for Cardiac Amyloidosis Gets FDA Breakthrough Therapy Designation

Attralus, Inc. announced that its investigational diagnostic imaging agent drug, ¹²⁴I-evuzamitide (AT-01), has been granted Breakthrough Therapy Designation (BTD) by the US. FDA for 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.

BTD is a program used by the FDA to expedite the development and review of a product when: (1) intended to treat or diagnose a serious or a life-threatening condition; and (2) when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints. BTD products are eligible for more intensive guidance from FDA to expedite development, including an organizational commitment by FDA and eligibility for Biologics License Application (BLA) rolling and priority review.

“We are highly encouraged by FDA’s decision to grant Breakthrough Therapy Designation to ¹²⁴I-evuzamitide (AT-01), recognizing its potential as an innovative diagnostic agent for patients with systemic amyloidosis” said Gregory Bell, MD, Chief Medical Officer, Attralus. “There are no FDA approved diagnostic imaging agents for cardiac amyloidosis. The diagnosis of cardiac amyloidosis is a challenging and time-consuming process for patients, with many going years without an accurate diagnosis, and losing critical time in the process. We remain committed to bringing ¹²⁴I-evuzamitide to the market as quickly as possible and look forward to working more closely with FDA to bring ¹²⁴I-evuzamitide to patients.”

¹²⁴I-evuzamitide (AT-01) is the first non-invasive pan-amyloid PET imaging agent specifically designed for systemic amyloidosis. ¹²⁴I-evuzamitide utilizes the company’s pan-amyloid binding peptide labeled with iodine-124 as an amyloid-specific imaging agent to image all types of systemic amyloidosis by PET/CT imaging. In clinical trials, ¹²⁴I-evuzamitide has been shown to detect multiple types of amyloid deposits, including ATTR and AL, in major organs such as the heart, kidney, liver, and spleen. Orphan drug designations have been granted to ¹²⁴I-evuzamitide as a diagnostic for the management of ATTR and AL amyloidosis by both the FDA and the European Commission.