Attralus To Present Phase 1/2 Data on Its Pan Amyloid Depleter at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition
- Initial results of a Phase 1 / 2 open label study of AT-02, the company’s lead pan-amyloid removal therapeutic candidate, in patients with AL amyloidosis will be presented at ASH.
- The presentation includes data on AL patients in hematological remission who received AT-02 (2.5 gm q2w) for 40 weeks and had improvement in renal function with a mean increase in eGFR of ~16 mL/min at Week 40.
- AL Amyloidosis is an unmet need with a US prevalence of ~25,000, with approximately ~70% of patients having renal impairment.
NAPLES, Fla., Nov. 04, 2025 (GLOBE NEWSWIRE) -- Attralus, Inc., is a clinical stage biopharmaceutical company developing transformative medicines and diagnostics to improve the lives of patients with systemic amyloidosis. The Company announced the presentation of a phase 1/2 study of AT-02, (a novel pan-amyloid depleter IgG fusion protein) in AL patients at the upcoming 67th ASH Annual Meeting and Exposition in Orlando, FL on December 6-9, 2025.
AT-02, the company’s lead pan-amyloid removal therapeutic candidate is a humanized, recombinant IgG1 monoclonal antibody fusion protein containing a peptide that mediates binding to all forms of amyloid. AT-02 has been shown to bind synthetic amyloid fibrils and diverse forms of human amyloid extracts with EC90 <1 nM, stimulate phagocytosis of amyloid fibrils, bind tissue amyloid in murine amyloidosis models, and reduce amyloid deposits in animal models. Because AT-02 binds to amyloid deposits and triggers amyloid reabsorption through opsonization, it may provide clinical benefit over therapies that reduce precursor proteins slowing amyloid deposition, which frequently do not result in restoration of organ function.
The AT-02 Phase 1/2 clinical program in AL participants consists of a single arm, open label 8-week multiple dose, dose escalation Phase 1 study and a Phase 2 open label extension study (OLE). A mean increase in eGFR of ~16 mL/min over 40 weeks above baseline was observed in patients who received AT-02 2.5 gm q2w. 83% (5/6) of the participants in the 2500 mg q2w cohort with data after 40 weeks of AT-02 treatment had an increase in eGFR from baseline, with 67% (4/6) experiencing a >10 mL/min/1.73 m2 increase in eGFR. One participant in the q2w dose cohort also met the proteinuria criteria with a baseline uACR 1349 mg/g. uACR decreased by 70% and 84% following 8 and 40 weeks of treatment with AT-02 2500 mg q2w, respectively. EGFR improvement was observed in both AL lambda & AL kappa in hematologic VGPR and CR patients and were observed in patients 1-6 years from AL diagnosis.
“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. "The Phase 1 / 2 data suggest AT-02 has the potential to improve renal function in AL amyloidosis patients in hematological remission."
“There is a significant unmet need for new therapies that can remove the existing amyloid fibrils that cause organ damage, dysfunction and are associated with mortality and morbidity,” said Ahmad Masri, M.D., Associate Professor of Medicine and Cardiomyopathy Section Head at Oregon Health & Science University. “These interim clinical data from AT-02 in AL patients in hematological remission with renal dysfunction demonstrates a rapid and significant improvement in eGFR and proteinuria, which are important markers of disease burden and outcomes. These data provide a highly encouraging foundation for a disease modifying treatment approach for AL amyloidosis patients with renal dysfunction using AT-02, with the potential to improve outcomes for patients.”
Oral Presentation Details
Abstract Title: Renal responses in a phase 1/2 study of at-02, a novel pan-amyloid depleter ig fusion protein for the treatment of patients with AL amyloidosis
Session Name: 652. MGUS, Amyloidosis, and Other Non-Myeloma Plasma Cell Dyscrasias: Clinical and Epidemiological: New therapies and treatment goals for AL amyloidosis
Session Date: December 7, 2025
Session Time: 4:30 p.m. – 6:00 p.m. EDT
Presentation Time: 5:00 p.m. – 5:15 p.m. EDT
Room: OCCC - Tangerine Ballroom F1
For additional information, please visit the ASH 2025 website.
About AT-02, Pan-Amyloid Removal Therapeutic
AT-02 is the company’s lead pan-amyloid removal (PAR) therapeutic candidate for systemic amyloidosis. AT-02 is a humanized IgG1 monoclonal antibody genetically fused with the company’s proprietary pan-amyloid binding peptide, enabling binding to multiple types of amyloid deposits. The Fc region of the antibody stimulates the immune system to remove amyloid deposits that are bound by AT-02. AT-02 uses a similar pan-amyloid peptide to 124I-evuzamitide, the company’s diagnostic agent, which has been shown in multiple clinical trials to selectively bind to amyloid deposits in the heart, liver, kidney, and other organs in multiple types of amyloidosis. As a result, the company expects AT-02 to bind specifically to amyloid in systemic amyloidosis patients. Preclinical data has shown the ability of AT-02 to bind to multiple amyloid types in major organs, induce macrophage mediated phagocytosis, and remove amyloid. AT-02 is currently being evaluated in a Phase 1 / 2 open label extension trial in AL amyloidosis patients.
About AL Systemic Amyloidosis
Systemic light chain amyloidosis (AL) is a progressive, systemic, multiorgan, orphan disease with significant morbidity. AL most commonly affects the heart and kidneys. US prevalence is ~25,000 with ~4,500 new patients diagnosed annually. AL is caused by small B cell clones that produce a toxic light chain forming amyloid deposits in tissues. The combination of daratumumab, cyclophosphamide, bortezomib and dexamethasone (dara-CyBorD) is the current standard of care, and profound hematologic response is the early goal of treatment. There are no approved therapies targeting the removal of amyloid. Amyloid depleter therapies are needed to improve organ function. There is a significant unmet need for patients in hematologic remission who have persistent organ dysfunction (cardiac or renal).
About Attralus
Attralus is a clinical stage biopharmaceutical company focused on creating transformative medicines and diagnostics 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 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. The Company’s lead diagnostic, 124I-evuzamitide, is in pivotal Phase 3 trials, utilizing the company’s pan-amyloid binding peptide labeled with iodine-124 as an amyloid-specific radiotracer to detect all types of systemic amyloidosis by PET/CT imaging. Attralus was founded by scientific experts in the field of amyloidosis, and the company is headquartered in Naples, FL.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the efficacy, continued development, and potential of AT-02. Words such as “developing,” “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:
Krishna Gorti, M.D. FRCS
Corporate Development
Attralus Inc.
kgorti@attralus.com