Attralus has dosed the first subject in the Phase I clinical trial of its lead pan-amyloid removal (PAR) therapy, AT-02, in healthy participants and systemic amyloidosis (SA) patients.

The two-part trial will assess the safety, tolerability and pharmacokinetics (PK) of single increasing doses of AT-02.

Part 1 of the trial is a double-blind, single-centre, single-ascending dose study enrolling healthy volunteers (HV). It will analyse the PAR therapeutic’s safety, tolerability and PK. 

The open-label, single-ascending dose Part 2 study will enrol SA patients to evaluate the safety, tolerability and PK of AT-02 and detect the maximum tolerated dose (MTD).

A humanised, full-length, recombinant immunoglobulin 1 (IgG1) monoclonal antibody (mAb) fusion protein, AT-02 is in the developmental stage for SA treatment.

It demonstrated to have subnanomolar binding potency to ATTR and AL amyloid as well as opsonise amyloid extracts boosting amyloid phagocytosis mediated by macrophage.

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According to in vivo preclinical findings, the therapy offered substantial amyloid decline in mouse models of human AL amyloidoma and systemic AA amyloidosis.

Nearly 50% reduction in local cardiac amyloid was observed in mice with progressive systemic AA amyloidosis, which received AT-02.

The treatment also substantially decreased renal and hepatic amyloid and organ impairment versus untreated animals.

Attralus chief medical officer Gregory Bell said: “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. 

“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.”

Systemic amyloidosis comprises various groups of rare ailments that arise due to the build-up of toxic amyloid deposits in tissues and organs.