Attralus Presents Clinical Data from Novel, Potential First-in-Class Diagnostic AT-01 for Systemic Amyloidosis at Virtual ASH 2020

SOUTH SAN FRANCISCO, Calif., Dec. 6, 2020 /PRNewswire/ -- Attralus, a biopharmaceutical company focused on creating transformative medicines and diagnostics to improve the lives of patients with systemic amyloidosis, today announced clinical data from its ongoing Phase 1/2 trial assessing AT-01, the Company's novel pan-amyloid imaging agent, in a virtual poster presentation at the 62nd Annual American Society of Hematology Meeting and Exposition (ASH 2020). Dr. Jonathan Wall, Director of the Amyloidosis and Cancer Theranostics Program at the University of Tennesee and co-inventor of AT-01, will present the data. 

The data demonstrate that PET/CT imaging using the AT-01 imaging agent can detect amyloid deposits in the heart and kidney as well as other organs in patients with AL amyloidosis. Importantly, these data also demonstrate that AT-01 has the potential to differentiate between AL and ATTR amyloidosis. There are currently no approved diagnostic imaging agents in the U.S. for systemic amyloidosis.

"We are very pleased to see that AT-01, our novel pan-amyloid imaging agent, may differentiate between AL and ATTR amyloidosis. These forms of amyloidosis are two of the most common, manifest in distinctive organs within the body, and have different underlying etiologies," said Spencer Guthrie, CEO of Attralus. "For the first time, these data begin to reveal a more robust understanding of each individual patient's disease, allowing us to take a comprehensive approach to diagnosis and tailoring of treatment. These data also have significant implications for the development of our therapeutics. The ability to visualize amyloid deposits on an organ-by-organ basis throughout the body may provide a greater understanding of disease progression, allow us to develop a more targeted approach to treat the disease, and potentilly monitor response to therapy."

Poster Session: 641: CLL: Biology and Pathophysiology, excluding Therapy: Poster II

Abstract Number: 2212                                                                  

Title: Detection of Systemic AL Amyloidosis and Differentiation of AL from ATTR Using ¹²⁴I-p5+14 PET Imaging

Lead Authors: Jonathan Wall, Eric Heidel, Alan Stuckey & Emily Martin

Results: 

Analysis of PET images indicated retention of AT-01 in the heart, kidneys, liver, spleen, pancreas, bone marrow, lung, and adrenal gland of AL patients. Cardiac uptake of AT-01 was observed in 70% and kidney uptake in 69% of of AL patients. Additionally, liver and spleen retention of AT-01 was observed in 38% and 61% of AL patients, respectively. The patient-based sensitivity was 93% (14/15 patients) and the cardiac specific sensitivity was 100%.

Upon analysis of standardized uptake value ratios for AT-01 in different organs of the body, it was possible to differentiate ATTR from AL patients (p = 0.002, AUC of 0.96). A cutoff value of 1.40 yielded a 100% sensitivity and 75% specificity for diagnosing ATTR relative to AL from the PET image data.

"AL amyloidosis is a life threatening, multi-system disease affecting numerous aspects of a patient's function and quality of life," said Jonathan Wall, Ph.D., Interim Chief Scientific Officer of Attralus, Professor of Medicine at the University of Tennessee Graduate School of Medicine, Knoxville and Director of the Amyloidosis and Cancer Theranostics Program. "These data indicate that AT-01 can detect amyloid in multiple organs associated with AL amyloidosis giving us confidence that AT-01 may be an accurate, non invasive, first-in-class agent for detecting AL and other forms of systemic amyloidosis."

AT-01 is a novel polybasic peptide radiotracer under clinical investigation for whole-body amyloid detection in diverse types of amyloidosis. Preliminary Phase 1/2 clinical data presented in September at ISA 2020, showed safety and efficacy of AT-01 as a pan-amyloid imaging agent that binds many forms of systemic amyloid including AL and ATTR. AT-01 has detected AL amyloid in the heart, kidneys, liver, spleen and lungs, and ATTR amyloid in the heart, nerves, lungs and connective tissue in the hands and spine – demonstrating the potential for AT-01 to serve as a first-in-class imaging agent for a range of systemic amyloid diseases. Additionally, amyloid was visualized in the hearts of AL and ATTR patients who have pre-symptomatic cardiac disease, potentially enabling earlier diagnosis of patients prior to the onset of symptoms.

About Attralus

Attralus, Inc. is a biopharmaceutical company focused on illuminating the systemic nature of amyloidosis and creating transformative medicines to improve the lives of patients. The company's proprietary peptide-based pan-amyloid targeting agents have the potential to diagnose and treat all forms and stages of systemic amyloidosis. In addition to AT-01, Attralus is developing two targeted therapeutics, which are currently in pre-clinical development for systemic amyloidosis.  Attralus is focused on targeting common pathology in all systemic amyloidosis diseases, with the goal of developing treatments for all types of amyloidosis, including the majority in which there are currently no treatment options. Attralus is headquartered in South San Francisco and was founded in 2019 with funding from venBio Partners. For more information, visit Attralus online and on Twitter.

SOURCE Attralus, Inc.