Argenx starts Phase II study of myasthenia gravis drug

Argenx, a European biopharmaceutical company focused on drugs for the treatment of cancer and autoimmune diseases, has initiated a Phase II proof-of-concept study of ARGX-113 in patients with myasthenia gravis (MG).

ARGX-113 has the potential to erase symptoms with minimum side effects that are common with current treatments nof MG, which is a rare and debilitating muscle disease, with limited treatments.

Nicolas Leupin, CMO argenx said: “The initiation of this Phase II study is an important milestone in understanding how ARGX-113 can be effective in a wide range of IgG-mediated autoimmune diseases including additional orphan indications, and larger indications like multiple sclerosis and lupus. We expect to start a Phase II trial in a second orphan IgG driven indication, immune thrombocytopenia (ITP), by the end of the first quarter of 2017.”

The double-blind, placebo controlled Phase II study will enrol up to 24 MG patients with confirmed generalized muscle weakness. ARGX-113 will be dosed on top of current standard of care, corticosteroids and/or immunomodulatory agents. The primary endpoints of the trial are safety and tolerability and secondary endpoints include efficacy, impact on quality of life and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers, said the company in its press release.

In Phase I clinical trials, 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.