ARTICLE | Clinical News

argenx reports Phase II myasthenia gravis data for ARX-113

December 15, 2017 3:50 AM UTC

argenx S.E. (Euronext:ARGX; NASDAQ:ARGX) reported top-line data from a Phase II study in 24 myasthenia gravis patients showing that 75% of patients treated with efgartigimod (ARGX-113) achieved at least a 2 point reduction from baseline in the Myasthenia Gravis Activity-of-Daily-Living (MG-ADL) score vs. 25% of placebo-treated patients (p=0.0391). Efgartigimod was well tolerated with no serious or severe adverse events reported. The trial enrolled patients with confirmed generalized muscle weakness and an MG-ADL score of at least five with more than 50% of the score consisting of non-ocular items. Patients received standard of care (SOC) plus once-weekly 10 mg/kg efgartigimod for four weeks or placebo.

The double-blind, international trial's primary endpoint is safety. Secondary endpoints include MG-ADL, Quantitative Myasthenia Gravis (QMG) test, Myasthenia Gravis Composite (MGC) scale, Myasthenia Gravis Quality of Life (MG-QOL), pharmacokinetics, pharmacodynamics and immunogenicity. ...

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