Dutch biopharmaceutical company Argenx recently reported initial data from its Phase 1 multiple ascending dose clinical trial of ARGX-113 in healthy volunteers.
ARGX-113 is designed for the management of acute autoimmune crisis (sudden and severe onset of symptoms between periods of remission) and could potentially be used for many rare medical conditions including systemic lupus erythematosus.
The first-in-class antibody fragment modified by Argenx’s proprietary ABDEG technology, ARGX-113 increases its target affinity (strength) beyond that of normal IgG antibodies, blocking antibody recycling and leading to faster clearance of IgG auto-antibodies (and therefore reducing inflammation).
IgG is a type of antibody (immunoglobulin IgG) most abundant in the body. In preclinical studies ARGX-113 demonstrated high potency and rapid onset of action in autoantibody reduction.
The trial is designed to evaluate the safety and tolerability of ARGX-113 and to identify a potential dose for future Phase 2 studies.
“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 favorable 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,” Argenx’s CMO Nicolas Leupin said in a recent press release. “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.”