SAN FRANCISCO, Calif. – October 17, 2022 – Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, today announced that the first subject has been dosed in the Phase 1 clinical trial of AT-02, the company’s lead pan-amyloid removal (PAR) therapeutic. The clinical trial is enrolling both healthy volunteers and patients with systemic amyloidosis.
“For systemic amyloidosis patients today, approved therapies target precursor protein production, reducing the formation of new amyloid, but there is a significant unmet need for new therapies that can remove the existing toxic amyloid fibrils, which cause organ damage and mortality in patients,” said Gregory Bell, M.D., Chief Medical Officer at Attralus. “AT-02 is designed to bind to all types of amyloid and induce immune-mediated phagocytosis. Based on the preclinical data, we believe AT-02 has the potential to remove existing amyloid and improve organ function and clinical outcomes for patients.”
AT-02 is a full-length, humanized, recombinant immunoglobulin 1 (IgG1) monoclonal antibody (mAb) fusion protein that is being developed to treat systemic amyloidosis (SA). AT-02 was shown to have subnanomolar binding potency to ATTR and AL amyloid and to opsonize amyloid extracts promoting macrophage-mediated phagocytosis of the amyloid in data presented at the 18th International Symposium on Amyloidosis. In vivo preclinical data demonstrated significant reduction in amyloid in mouse models of human AL amyloidoma and systemic AA amyloidosis. Treatment of mice with progressive systemic AA amyloidosis with AT-02 reduced local cardiac amyloid by ~50% and significantly reduced renal and hepatic amyloid and organ impairment as compared to untreated animals.
The Phase 1 trial is a two-part study designed to evaluate the safety, tolerability, and PK of rising single doses of AT-02 in healthy volunteers (HV) and in patients with SA (ClinicalTrials.gov identifier: NCT05521022). Part 1 is a double-blind, single-center, single-ascending dose study in HV to assess the safety, tolerability, and PK of AT-02. Part 2 is an open label, single-ascending dose study in subjects with systemic amyloidosis to assess the safety, tolerability, and PK of AT-02 and to identify a maximum tolerated dose (MTD).
About AT-02 PAR Therapeutic
AT-02 is a fusion of our pan-amyloid removal (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. A similar PAR-peptide technology is utilized in AT-01 (iodine (I-124) evuzamitide).
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.
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.
This press release contains forward-looking statements, including statements related to the efficacy, continued development, and potential of the Company’s product candidates. Words such as “novel,” “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.