"The Phase 1 data published today in the peer-reviewed Journal of Clinical Investigation highlight the unique design of efgartigimod as an Fc fragment modified by our proprietary ABDEG(TM) technology. The drug candidate's binding properties with FcRn are enhanced by the ABDEG mutation, which may contribute to the differentiated pharmacokinetic and pharmacodynamic activity we saw in the Phase 1 study, as well as its favorable tolerability profile," said Nicolas Leupin, CMO of argenx. "We have launched a broad development strategy to explore efgartigimod in a range of indications mediated by pathogenic IgGs to further our understanding of its mechanism of action and evaluate whether FcRn blockage translates into clinical improvements in severe autoimmune diseases."
The Phase 1 data published in JCI show that the FcRn antagonist efgartigimod was observed to have a favorable tolerability profile and led to a specific, profound and sustained reduction of total immunoglobulin G (IgG) levels. In healthy volunteers, multiple doses of efgartigimod lowered IgG levels on average by approximately 75% with levels returning to baseline approximately eight weeks following the last administration. Efgartigimod was observed to be selective to IgG and did not affect the homeostasis of albumin or immunoglobulins other than IgG."
- From argenx SE press release