Attralus Announces Presentation of Clinical Data on AT-01, a Novel Diagnostic for Systemic Amyloidosis, at the 2021 Society of Nuclear Molecular Imaging Meeting

• AT-01 is a first-in-class pan-amyloid imaging agent capable of detecting diverse types of amyloid
• AT-01 identified amyloid in anatomic sites not detected clinically, including pre-symptomatic cardiac amyloid

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 the presentation of clinical data for AT-01, a first-in-class pan-amyloid imaging agent, at the 2021 Society of Nuclear Molecular Imaging (SNMMI) annual meeting by the company’s co-founder and interim Chief Scientific Officer, Jonathan Wall, PhD, a distinguished professor and director of the University of Tennessee Graduate School of Medicine’s Amyloidosis and Cancer Theranostics Program.

An oral presentation and posters described results from a clinical study evaluating AT-01 (¹²⁴I-p5+14), a novel, radiolabeled, synthetic amyloid-targeting peptide designed for imaging systemic amyloid deposits. The data demonstrated that positron emission tomography (PET) and computed tomography (CT) imaging using AT-01 enabled detection of seven types of amyloid (ATTRwt, ATTRv, AL, ALys, AGel, AApoA1, and ALect2) and identified amyloid in anatomic sites not detected clinically, including pre-symptomatic cardiac amyloid.

“Systemic amyloidosis is a disease with heterogeneous presentation, making rapid and accurate diagnosis challenging. Currently, a definitive diagnosis of systemic amyloidosis is often made following histological evaluation of a tissue biopsy,” said Dr. Wall. “PET/CT imaging, using AT-01, can detect many forms of amyloid throughout the body, which opens up new opportunities for rapid and effective diagnosis. In addition, this imaging modality may provide further clinical information to help improve patient management and disease understanding.”

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.

The presentation and posters at SNMMI highlighted the potential of AT-01 to be the first amyloidosis-specific imaging agent with the ability to:

• PET/CT imaging using AT-01 enabled detection of seven types of amyloid (ATTRwt, ATTRv, AL, ALys, Agel, AApoA1, ALect2)
• In many patients, radiotracer uptake in amyloid was observed in anatomic sites not identified in the clinical record, many of these anatomic sites consistent with expected areas of amyloid deposition.
• PET/CT imaging of patients with amyloidosis using AT-01 provides not only a discrimination of the presence of amyloid, but it also provides additional clinically relevant information that can be used for patient management and improving outcomes.
• A facile region of interest image analysis can quantify the uptake of AT-01 in abdominothoracic organs and provide the basis for a routine method for quantifying amyloid load in patients with systemic amyloidosis.

“We anticipate that use of AT-01 in PET/CT imaging of patients with amyloidosis will become an essential tool not only to accelerate diagnosis, but to provide clinically-relevant information for patient management and improving outcomes,” said Gregory Bell, MD, Chief Medical Officer at Attralus. “Importantly, these data are invaluable as we develop a portfolio of pan-amyloid removal (PAR) therapeutics for systemic amyloidosis which offer the potential to remove toxic, disease-causing amyloid and to reverse disease pathology.”

AT-01 is currently being evaluated in a Phase 1/2 clinical trial in patients with a range of types of systemic amyloidosis. The SNMMI presentations and posters are 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 stimulate 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 “demonstrated,” “may,” “anticipate” 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.

Contacts

Kathryn Morris

The Yates Network

914-204-6412

[email protected]