Study Update: AT-01 for Systemic Amyloidosis

From June 11th until the 14th, the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting was held in Vancouver, Canada. At this meeting, Attralus Inc. shared new data from its phase 1/2 trial evaluating AT-01, also known under the generic name Iodine I-124 evuzamitide, as a diagnostic tool for various forms of systemic amyloidosis. Interested in listening to the oral presentation or viewing the poster presentation? You can find them at the SNMMI Annual meeting website.

About Amyloidosis

Amyloidosis is an umbrella category for a number of diseases that are characterized by deposits of the amyloid protein in different organs, such as the heart and kidneys. Symptoms depend on which organ is impacted. For example, cardiac amyloidosis leads to effects like dizziness, chest pain, weight loss, nausea, insomnia, heart palpitations, swollen legs, fatigue, abnormal heart rhythms, and shortness of breath. When the nervous system is affected, symptoms include autonomic neuropathy, peripheral neuropathy, and sensorimotor impairment. Causes vary based on the type of amyloidosis one has. Similarly, treatment varies based on type and what organ is impacted.

AT-01 for Amyloidosis

The trial is taking place at the University of Tennessee Graduate School of Medicine, and it evaluates Attralus’ investigational pan-amyloid binding peptide. The goal is to use this peptide as a radiotracer and to use it in the diagnosis of systemic amyloidosis. 57 participants enrolled in the trial, all of whom were given IV infusions of AT-01. The dosage was <2 mg of AT-01 (≤2 mCi). Five hours after the injection was administered, the researchers utilized Biograph PET/CT paired with a low dose CT to take images. The following results were shared:

  • In 96% of patients, PET/CT scans were able to detect AT-01 uptake with high sensitivity, especially in the heart
  • There was a positive percent agreement (PPA) of 96.2% between AT-01 uptake in the heart and clinical evaluation
    • The PPA between the kidneys and clinical evaluation was 78.6%
  • There was a negative percent agreement (NPA) of 100% in the hearts of healthy participants, and an NPA of 80% in their kidneys
  • In patients with AL amyloidosis, there was a Spearman rank-order correlation of 0.50 between NTproBNP and cardiac standard uptake value ratio (SUVR)
  • There was a decrease in serum light chain levels and serum alkaline phosphatase of 15 mg/dL and ~80 IU/mL, respectively
  • Improvements in serum biomarkers of organ function and serum free light chains corresponded with visualizations of organ-specific regression of amyloid deposits
  • For the manual method, changes in hepatic uptakes were -22.6%
    • Splenic uptakes were -53.2%
    • Renal uptakes were +13.1%
    • Cardiac uptakes were +18.2%
  • For the automated method, changes in hepatic uptakes were -25.5%
    • Splenic uptakes were -56.3%
    • Renal uptakes were +12.9%
    • Cardiac uptakes were +19.6%
  • Uptakes in AT-01 in various organs, such as the spleen, kidneys, heart, pancreas, bone marrow, and liver was observable on CT and PET images
  • Significant correlation between between the quantitative analyses of CT and PET images performed by fully automated 3D and manual 2D methods
  • When there is stable or increasing amyloid deposition in the kidneys and heart, there may be a reduction of hepatosplenic amyloid when a patient is treated with the standard of care

These data prompt further investigation into what AT-01 can do in the diagnosis of systemic amyloidosis. As early diagnosis leads to much better outcomes for patients, advances in this field are extremely important to both patients and doctors.

Find the source article from GlobeNewswire.

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