Positive New Data from Phase 1/2 Trial of AT-01 (Iodine I-124 Evuzamitide) Presented at 2022 Society of Nuclear Medicine & Molecular Imaging Annual Meeting

• AT-01 is the first pan-amyloid imaging agent capable of detecting diverse types of systemic amyloidosis
• AT-01 visualizes and quantifies organ-specific changes in amyloid load over time
• AT-01 detected patients with diverse types of systemic amyloidosis, by PET/CT imaging, with high sensitivity, notably in the heart
  

SAN FRANCISCO, June 14, 2022 (GLOBE NEWSWIRE) -- Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, today announced encouraging new clinical data from the University of Tennessee Graduate School of Medicine from its Phase 1/2 trial of AT-01 (Iodine I-124 evuzamitide), the company’s pan-amyloid binding peptide in development as a radiotracer for the diagnosis of multiple types of systemic amyloidosis. These data were included in oral and poster presentations at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) Annual Meeting taking place June 11-14, 2022, in Vancouver, BC, Canada.

The Phase 1/2 trial evaluated the ability of AT-01 to detect amyloid deposits by PET/CT imaging in patients with diverse types of systemic amyloidosis. The study enrolled a total of 57 subjects, 50 of which had systemic amyloidosis, two of which were asymptomatic ATTR carriers, and five of which were healthy volunteers. All patients received an IV infusion of <2 mg of AT-01 (≤2 mCi), and images were acquired at 5 hours post injection using a Biograph PET/CT with a low dose CT.

“AT-01 in PET/CT imaging of patients with systemic amyloidosis has the potential to become an essential tool not only to accelerate and streamline diagnosis, but also to provide a comprehensive assessment of disease burden and a means to monitor disease progression,” said Gregory Bell, MD, Chief Medical Officer at Attralus. “Today the diagnosis of amyloidosis is a long, complex process, and many patients with systemic amyloidosis remain undiagnosed. AT-01 has the potential to be the first and only non-invasive, pan-amyloid, whole body imaging diagnostic designed to detect all types of systemic amyloidosis across key organs.”

AT-01 Final Results Summary

• AT-01 uptake was detected in 96% of patients with diverse forms of amyloidosis (ATTR, AL, AA, ALECT2), by PET/CT imaging, with high sensitivity, notably in the heart.
• The positive percent agreement (PPA) between clinical evaluation and AT-01 uptake in heart and kidneys was 96.2% (95% CI: 80.4, 99.9; n = 26) and 78.6% (95% CI: 49.2, 95.3; n = 14).
• The negative percent agreement (NPA) assessed in healthy subjects, for the heart and kidneys was 100% and 80%, respectively (n = 5).
• The Spearman rank-order correlation between cardiac standard uptake value ratio (SUVR) and NTproBNP in subjects with AL amyloidosis was 0.50 (p = 0.0209). 

AT-01 Repeat Imaging Results Summary

• Organ-specific regression of amyloid deposits was visualized using AT-01, occurring with corresponding improvement in serum free light chains and in serum biomarkers of organ function.
• The PET/CT images indicated amyloid uptake of the radiotracer in the heart, spleen, liver, kidneys, pancreas, and bone marrow.
• Quantitative analysis of PET/CT images by manual 2D and fully automated 3D methods correlated significantly (r_P < 0.98; p < 0.02). 
• Changes in hepatic, splenic, renal, and cardiac uptake were -22.6%, -53.2%. +13.1%, +18.2% for the manual method, and -25.5%, -56.3%, +12.9%, +19.6% for the automated method.
• Concurrently, serum free light chain levels and serum alkaline phosphatase decreased from 38 mg/dL to 23 mg/dL and ~200 IU/mL to ~120 IU/mL, respectively.   
• Reduction in hepatosplenic amyloid in response to standard of care treatment may occur in the context of stable or increasing amyloid deposition in the heart and kidneys.

“Systemic amyloidosis is a multi-organ disorder with variable presentation rendering rapid and accurate diagnosis challenging,” said Jonathan Wall, Ph.D., Distinguished Professor, University of Tennessee Graduate School of Medicine. “AT-01 offers the potential to diagnose and quantify amyloid burden, as well as monitor the disease over time.”

For additional information, please visit the SNMMI Annual Meeting website.

About AT-01 Pan-Amyloid Diagnostic  

AT-01 (I-124 Evuzamitide) utilizes the company’s pan-amyloid binding peptide as an amyloid-specific radiotracer to image all types of systemic amyloidosis by PET/CT imaging. In initial clinical trials, AT-01 has been shown to detect multiple types of amyloid deposits, including AL and ATTR, in major organs such as the heart, kidney, liver and spleen. Attralus obtained exclusive rights to commercialize AT-01 under a commercial license agreement with the University of Tennessee Research Foundation. The same PAR-peptide technology is utilized in AT-02 and AT-04, two of the company’s therapeutic candidates.  

About Systemic Amyloidosis  

Systemic amyloidosis encompasses a diverse group of rare diseases that occur due to accumulation of toxic amyloid deposits in tissues and organs, a consequence of aberrant protein misfolding events. These diseases are progressive, debilitating and often fatal. Systemic amyloidosis is significantly underdiagnosed due to low awareness, lack of specific symptoms, and no current disease-specific diagnostics. The two most common forms of systemic amyloidosis are immunoglobulin light-chain-associated (AL) amyloidosis and transthyretin-associated amyloidosis (ATTR). There is a significant unmet need for new therapies and diagnostics in systemic amyloidosis.  

About Attralus   

Attralus is a clinical stage biopharmaceutical company focused on creating transformative medicines to improve the lives of patients with systemic amyloidosis. The company’s proprietary pan-amyloid removal (PAR) therapeutics are designed to directly bind to and remove toxic amyloid in organs and tissues. By targeting the universal disease-causing pathology in systemic amyloidosis diseases, PAR therapeutics have the potential to treat and reverse disease in patients with all types and stages of systemic amyloidosis. Attralus was founded by scientific experts in the field of amyloidosis and the company is headquartered in San Francisco.  

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to the efficacy, continued development, and potential of AT-01. Words such as “developing,” “first and only,” “potential,” “shown” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Attralus' current expectations. Forward-looking statements involve risks and uncertainties. Attralus' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Attralus expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Attralus' expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. 

Contact:

Luke Heagle
Real Chemistry
(910) 619-5764
lheagle@realchemistry.com