Attralus, Inc., a clinical-stage biopharmaceutical company, has initiated the Phase 1 clinical trial for AT-02, its lead pan-amyloid removal (PAR) therapeutic candidate. This trial marks a significant step forward in the development of treatments for systemic amyloidosis, a group of rare diseases characterized by the accumulation of toxic amyloid deposits in tissues and organs.
Gregory Bell, M.D., Chief Medical Officer at Attralus, highlighted the critical need for therapies that can remove existing amyloid fibrils, which are responsible for organ damage and mortality in patients. AT-02 is designed to bind to all types of amyloid and induce immune-mediated phagocytosis, offering hope for improved organ function and clinical outcomes.
AT-02 is a humanized, recombinant immunoglobulin 1 (IgG1) monoclonal antibody (mAb) fusion protein. Preclinical data presented at the 18th International Symposium on Amyloidosis demonstrated AT-02's subnanomolar binding potency to ATTR and AL amyloid, as well as its ability to promote macrophage-mediated phagocytosis of amyloid. In vivo studies showed significant reductions in amyloid in mouse models of human AL amyloidoma and systemic AA amyloidosis, with notable improvements in cardiac, renal, and hepatic amyloid levels and organ function.
The Phase 1 trial is structured in two parts: the first part is a double-blind, single-center, single-ascending dose study in healthy volunteers to evaluate safety, tolerability, and pharmacokinetics (PK). The second part is an open-label, single-ascending dose study in patients with systemic amyloidosis, aiming to identify a maximum tolerated dose (MTD).
Systemic amyloidosis is a debilitating and often fatal condition, with AL amyloidosis and ATTR amyloidosis being the most common forms. The lack of specific symptoms and diagnostics contributes to the underdiagnosis of these diseases. Attralus's PAR therapeutics, including AT-02, represent a promising approach to directly target and remove toxic amyloid, potentially reversing disease progression in patients with systemic amyloidosis.
Attralus, headquartered in San Francisco, is dedicated to developing transformative medicines for patients with systemic amyloidosis. The company's innovative PAR technology aims to address the universal pathology of amyloidosis, offering a new hope for patients across all types and stages of the disease.
