argenx announces initial results from Phase 1 multiple ascending dose study of ARGX-113 in healthy volunteers
30 June 2016 – Breda, the Netherlands / Ghent, Belgium – argenx, a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced initial results from its Phase 1 multiple ascending dose (MAD) study of ARGX-113
in healthy volunteers. The compound continues to show favorable safety and tolerability across multiple doses and dosing regimens with promising pharmacodynamics effects relating to speed, depth and duration of IgG reduction.
“We are pleased to share these preliminary results as they strongly support further study of ARGX-113 in severe autoimmune diseases. The repeated dosing in healthy volunteers resulted in very favourable PK/PD effects including specific IgG reduction of up to 85% and a long duration of effect given the simple and fast administration of the treatment,” commented Nicolas Leupin, CMO of argenx. “Overall, these results confirm the potential for ARGX-113 to become a breakthrough therapy for the treatment of severe IgG-mediated autoimmune disease and we expect to start our first Phase 2 trial in myasthenia gravis by the end of 2016.”
The Phase 1 double-blind, placebo-controlled study will enrol up to 68 healthy adult volunteers to evaluate the safety and tolerability of ARGX-113 and to identify a potential dose for future Phase 2 studies.
ARGX-113 is a novel approach to manage exacerbations of severe, IgG-mediated autoimmune diseases including multiple sclerosis and systemic lupus erythematosus as well as a wide range of orphan autoimmune diseases (such as myasthenia gravis, autoimmune skin blistering diseases, etc.) for which there are currently insufficient treatment options. In preclinical studies, ARGX-113 demonstrated high potency and rapid onset of action in autoantibody reduction.
ARGX-113 is a potential breakthrough therapy for treatment of IgG-mediated autoimmune diseases. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology to increase its affinity for FcRn beyond that of normal IgG antibodies. As a result, ARGX-113 blocks antibody recycling and leads to fast depletion of the autoimmune disease-causing IgG autoantibodies.