Belgium-based biotechnology firm argenx has initiated a Phase II clinical trial of its investigational agent, ARGX-113, to treat patients with pemphigus vulgaris (PV).
PV is a chronic and severe auto-immune disease of the skin and ARGX-113 is being developed to treat IgG-mediated autoimmune disorders.
The investigational therapy is the Fc-portion of an antibody altered by the firm using its ABDEG technology to enhance affinity for FcRn.
ARGX-113 works by blocking antibody recycling that results in rapid IgG autoantibodies, which are responsible for autoimmune disease.
The open-label, non-controlled, proof-of-concept Phase II trial will evaluate ARGX-113 in approximately 12 newly diagnosed or relapsing patients with mild-to-moderate PV.
The trial’s primary endpoints are safety and tolerability, while secondary endpoints are efficacy, and pharmacokinetics (PK) and pharmacodynamic (PD) markers.
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Interim results from the trial are expected to be reported in the second half of next year.
argenx chief medical officer Nicolas Leupin said: “We are thrilled about the therapeutic potential of ARGX-113 in PV, based on its mode of action of clearing IgGs.
“PV represents a clean and rapid proof-of-concept indication and, we believe, is therefore our ideal beachhead into the field of severe auto-immune blistering diseases of the skin.”
The firm is further studying ARGX-113 in two other Phase II trials for myasthenia gravis (MG) and immune thrombocytopenia (ITP).
Top-line results from the clinical trial for MG are expected to be available in the first quarter of next year and estimated to be in the second half of the ITP trial.
According to the results from a previous Phase I trial, the investigational candidate was well-tolerated at various doses and dosing regimens, demonstrating favourable pharmacodynamic effects.