argnex half through myasthenia gravis drug study

argenx, a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, 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.”

argenx said that 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 company said.

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.