argenx Issues Statement Concerning Efgartigimod

      -No observed elevation of cholesterol markers related to treatment with efgartigimod

February 2, 2021

Breda, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), today provided a statement in response to news from Immunovant regarding a voluntary pause of dosing in its ongoing trials for IMVT-1401, an FcRn antagonist. Today’s announcement by Immunovant was issued following an observed signal of elevated total cholesterol and LDL levels in one of its ongoing trials.

argenx has evaluated efgartigimod in over 350 subjects and patients, and is not aware of any elevation of cholesterol markers related to treatment with efgartigimod.

Total cholesterol, HDL and LDL were measured in at least 117 subjects in multiple Phase 1 healthy volunteer trials and there were no observed increases from baseline measurements over time. Additionally, total cholesterol, HDL and LDL were measured in 167 patients throughout the 26-week placebo-controlled Phase 3 ADAPT trial and efgartigimod was observed to have a comparable profile to placebo.

About Efgartigimod

Efgartigimod is an investigational antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels representing a logical potential therapeutic approach for several autoimmune diseases known to be driven by disease-causing IgG antibodies, including: myasthenia gravis (MG), a chronic disease that causes muscle weakness; pemphigus vulgaris (PV), a chronic disease characterized by severe blistering of the skin; immune thrombocytopenia (ITP), a chronic bruising and bleeding disease; and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disease leading to impaired motor function. The subcutaneous formulation of efgartigimod is co-formulated with Halozyme’s ENHANZE drug delivery technology and is administered as a 1000mg weekly single injection.

About argenx

argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States, and Japan.