- Favourable safety and tolerability profile observed
- Rapid reduction of IgG levels
Breda, the Netherlands / Ghent, Belgium – argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announced that it has completed the dose-escalation part of a Phase 1 study of ARGX-113. Initial results show the compound to be safe and well-tolerated across all doses in healthy volunteers.
“We are encouraged by the preliminary results of the Phase 1 single ascending dose study of ARGX-113 and the favorable safety and tolerability profile that was demonstrated under blinded conditions. We saw pharmacokinetic (PK) profiles across the dose ranges that were consistent with our expectations and additionally, promising pharmacodynamics (PD) effects relating to speed, depth and duration of IgG reduction, the PD marker for efficacy,” commented Tim Van Hauwermeiren, CEO of argenx. “These results confirm the potential of ARGX-113 to become a breakthrough therapy for the treatment of severe IgG- mediated autoimmune diseases. With the selected doses, we plan to initiate the multiple ascending dose study of the Phase 1 clinical trial.”
ARGX-113 is a novel approach to manage exacerbations of IgG-mediated autoimmune diseases including systemic lupus erythematosus as well as a wide range of severe autoimmune diseases, including orphan autoimmune diseases for which there are currently insufficient treatment options. In preclinical studies, ARGX-113 demonstrated high potency and rapid onset of action in autoantibody reduction.
About ARGX-113 Phase 1 study
The Phase 1 study, where 20 healthy volunteers were treated with escalating doses of ARGX-113, is a double-blind, placebo-controlled study. The objective is to evaluate the safety and tolerability of ARGX-113 and to identify a potential dose for future Phase 2 studies. The topline results from the complete Phase 1 study are expected by mid 2016.
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 ABDEGTM 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.