argenx kicks off phase II of immune thrombocytopenia treatment 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 started dosing of the first patient in a Phase II proof-of-concept study of ARGX-113 in patients with primary immune thrombocytopenia (ITP).

“The initiation of the second Phase II trial for our lead candidate, ARGX-113, is an important milestone for the company as it exemplifies the breadth of potential this compound has to address a wide variety of diseases that are driven by pathogenic IgGs,” commented Nicolas Leupin, CMO of argenx. “We believe ARGX-113 could be a breakthrough therapy in an indication like ITP where current therapies do not adequately address symptoms or achieve remissions.”

The company said that double-blind, placebo controlled Phase II study will enrol up to 36 ITP patients with platelet levels lower than 30 million per milliliter. ARGX-113 will be dosed on top of current standard of care, corticosteroids and/or immunomodulatory agents and/or TPO-R agonists. The primary endpoints of the trial are safety and tolerability and secondary endpoints include effect on platelet count and use of rescue treatment, and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers.

The comapny noted that in Phase I clinical trial, ARGX-113 demonstrated favorable safety and tolerability across multiple doses and dosing regimens with promising pharmacodynamics effects relating to speed, depth and duration of IgG reduction.