Attralus Announces Presentation of Clinical Data on AT-01, a Novel, Potential First-in-Class Diagnostic for Systemic Amyloidosis at the 2021 American College of Cardiology Annual Meeting

May 17, 2021 11:00 UTC

• AT-01 detected cardiac amyloid in AL and ATTR patients with known cardiac disease with 95% sensitivity
• AT-01 detected cardiac amyloid in patients with AL or ATTR amyloid with normal levels of serum NT-proBNP
• AT-01 has the potential to distinguish AL and ATTR amyloidosis based on organ distribution

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Attralus, a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, today announced presentation of clinical data at the 2021 American College of Cardiology (ACC) annual meeting by the company’s co-founder and interim Chief Scientific Officer, Jonathan Wall, PhD, who is a distinguished professor and director of research at the University of Tennessee Graduate School of Medicine’s Amyloidosis and Cancer Theranostics Program.

The presentation described results from a clinical study evaluating AT-01 (¹²⁴I-p5+14), a novel, radiolabeled, synthetic amyloid-targeting peptide designed for imaging amyloid deposits, including those in the heart of patients with different types of systemic amyloidosis. The study demonstrated that positron emission tomography (PET) and computed tomography (CT) imaging using AT-01 enabled detection of cardiac amyloid in 95% of patients with a known history of cardiac amyloid as well as in patients with normal serum levels of NT-proBNP (a biomarker for cardiac amyloidosis). The study also provided a novel way to discriminate transthyretin-associated (ATTR) from light chain-associated (AL) amyloidosis, using the imaging data, and provided insight into disease processes and mechanisms.

“Deposition of amyloid in the heart is often observed in patients with AL and ATTR amyloidosis, and yet an estimated 80% of patients with systemic amyloidosis are currently undiagnosed, and treatment begins late in the course of the disease,” said Dr. Wall. “PET/CT imaging of cardiac amyloidosis using AT‑01 affords sensitive detection of disease, even in asymptomatic people with normal levels of NT-proBNP, a highly sensitive and validated biomarker of cardiac involvement in patients with amyloidosis. AT-01 is a novel diagnostic that provides the potential to change the treatment paradigm by enabling detection of all types of systemic amyloidosis at all stages of disease.”

Currently, there are no FDA-approved imaging agents as diagnostics for systemic amyloidosis. Patients typically undergo a multitude of diagnostic tests, none of which can visualize the extent and localization of amyloid deposition across the entire body.

Key findings reported in the poster presented at ACC, entitled “Detection and differentiation of cardiac amyloidosis using ¹²⁴I-p5+14 PET/CT imaging and the correlation with clinical biomarkers,” highlight the potential of AT-01 to be the first amyloidosis-specific imaging agent capable of detecting all amyloid types, in key organs, providing a complete picture of disease burden and enabling organ-specific amyloid quantification early indication of amyloid type, and monitoring response to therapy. The results presented include:

• Excellent cardiac uptake of AT-01 in patients, enabling identification of clinical cardiac disease in multiple types of systemic amyloidosis, AL and ATTR, with 95% sensitivity.
• Detection of cardiac amyloidosis in asymptomatic patients despite those patients having normal levels of NT-proBNP, a biomarker of amyloidosis complicated by cardiac involvement.
• Ability of AT-01 to detect systemic amyloid and differentiate between AL and ATTR amyloidosis, offering the potential to improve and customize treatment decisions.

“Attralus is developing a portfolio of products using our Pan Amyloid Removal technology which offer the potential to remove toxic, disease-causing amyloid throughout the body with high specificity and reverse disease pathology,” said Gregory Bell, MD, Chief Medical Officer at Attralus. “The AT-01 clinical data presented by Dr. Wall support our plans to utilize this revolutionary diagnostic to better identify and monitor systemic amyloidosis patients in our therapeutic programs in addition to our plan to bring AT-01 to patients.”

AT-01 is currently being evaluated in a Phase 1/2 clinical trial in patients with a range of types of systemic amyloidosis. The poster presented at the ACC is available on the Attralus website at www.attralus.com.

About AT-01 Pan-Amyloid Diagnostic

AT-01 utilized our pan-amyloid technology to develop an amyloid specific imaging radiotracer to detect all types of systemic amyloidosis. The peptide radiotracer has been shown to detect all types of amyloid, including AL and ATTR, in major organs such as the heart, kidney, liver and spleen.

About AT-02 PAR Therapeutic

AT-02 is a fusion of our PAR-peptide technology with an IgG1 antibody. The proprietary peptide binds to all types of amyloid and delivers the antibody to the site of disease to stimulate the immune system to remove amyloid

About AT-03 PAR Therapeutic

AT-03 is a fusion of our PAR-SAP technology with a single chain Fc. The PAR-SAP component mediates binding to all types of amyloid and the single chain Fc to stimulates the immune system to remove amyloid.

About AT-04 PAR Therapeutic

AT-04 is a fusion of our PAR-peptide technology with the Fc component of an IgG1 antibody. The PAR-peptide mediates binding to all types of amyloid and the Fc stimulates the immune system to remove amyloid.

About Systemic Amyloidosis

Systemic amyloidosis encompasses a diverse group of rare diseases that occur due to accumulation of toxic amyloid fibrils 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 (AL) amyloidosis and transthyretin amyloidosis (ATTR).

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 South San Francisco.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to Attralus’ continued development of AT-01, including the efficacy and therapeutic potential of AT-01. Words such as “potential,” “plan” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Atrralus' 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.

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