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argenx Presents Additional Efgartigimod Data from Global Phase 3 ADAPT Trial at the Myasthenia Gravis Foundation of America 2020 Scientific Session

Published: 2020-10-05 05:00:00 ET
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  • New data consistent with positive topline results showing rapid and clinically meaningful responses to efgartigimod and safety profile comparable to placebo 
  • Biologics License Application on track to be submitted to U.S. Food and Drug Administration by end of 2020

             

October 5, 2020Breda, the Netherlands / Ghent, Belgium – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced the presentation of new data from the pivotal Phase 3 ADAPT trial evaluating efgartigimod for the treatment of patients with generalized myasthenia gravis (gMG). The presentation took place on Saturday, October 3, 2020 at the Myasthenia Gravis Foundation of America (MGFA) 2020 Virtual Scientific Session. argenx previously reported positive topline results from ADAPT in May 2020.

“Myasthenia gravis can be a very debilitating and potentially life-threatening chronic disease in patients leading to impairments that affect a patient’s ability to complete normal daily activities, including walking, swallowing, chewing food, talking or breathing easily. Efgartigimod demonstrated in ADAPT that it is well-tolerated and that patients can experience clinically meaningful improvements in key measures of function and strength following treatment, including, in some, the achievement of minimal symptom expression. These exciting results suggest that efgartigimod as a new potential therapy for gMG patients could have a real impact on some of the daily limitations that patients face,” commented James F. Howard Jr., M.D., Professor of Neurology (Neuromuscular Disease), Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine and principal investigator for the ADAPT trial.

Highlights of New Data Presented at MGFA 2020 Virtual Scientific Session

Magnitude of response: Substantial proportion of efgartigimod-treated acetylcholine receptor-antibody positive (AChR-Ab+) patients showed benefit at increasing thresholds on the Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores compared to placebo patients at week four (one week after first treatment cycle).

  • At least half of efgartigimod-treated patients showed a five-point or greater improvement on the MG-ADL score (55.6%) and a six-point or greater improvement on the QMG score (50.0%)
  • One third (33.9%) of efgartigimod-treated patients showed a nine-point or greater improvement on the QMG score compared to zero patients on placebo

Repeatability of response: Similar proportion of efgartigimod-treated AChR-Ab+ patients were MG-ADL responders in the first (67.7% efgartigimod versus 29.7% placebo) and second (70.6% efgartigimod versus 25.6% placebo) treatment cycles (p