- 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.”