Date: 2017-05-04
Type of
information: update on patient enrollment
phase: 2
Announcement: update on patient enrollment
Company: Argen-X (Belgium - The Netherlands)
Product: ARGX-113
Action
mechanism:
- monoclonal antibody. ARGX-113 is the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG™ 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. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University (TAMHSC)).
Disease: myasthenia gravis
Therapeutic
area: Rare diseases - Genetic diseases - Neuromuscular diseases
Country: Belgium, Canada, Italy, The Netherlands, Poland, Spain, Sweden, USA
Trial
details: This is a randomized, double-blind, placebo-controlled, multicenter Phase II study to evaluate the safety, efficacy, and pharmacokinetics of ARGX-113 for the treatment of autoimmune myasthenia gravis with generalized muscle weakness. (NCT02965573)
Latest
news:
- • On May 4, 2017, argenx announced that it has recruited 50% of the myasthenia gravis patients in the Phase 2 proof-of-concept study of ARGX-113.
- 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.
• On January 9, 2017, argenx announced the initiation of a Phase II proof-of-concept study of ARGX-113 in patients with myasthenia gravis. 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 and pharmacodynamic markers.
Is
general: Yes
