argenx (Euronext Brussels: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced that it has recruited 50% of the myasthenia gravis (MG) patients in the Phase 2 proof-of-concept study of ARGX-113.
"We are encouraged by the pace of enrollment in this trial," commented Nicolas Leupin, Chief Medical Officer of argenx. "We now expect to present the top-line data of the ARGX-113 clinical trial in MG in the first quarter of 2018."
The double-blind, placebo controlled Phase 2 study is enrolling up to 24 MG patients with confirmed generalized muscle weakness. ARGX-113 is being dosed on top of current standard of care, including cholinesterase inhibitors, steroids and/or immunosuppressants. The primary objectives of the trial are safety and tolerability, and secondary objectives include efficacy and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers.
The MG clinical trial was launched in January of this year. ARGX-113 is also being studied in a Phase 2 proof-of-concept study for the treatment of primary immune thrombocytopenia, which was initiated in March 2017.
ARGX-113 is an investigational 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.
argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.