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Argen-X N.V. (Argenx). (10/22/15). "Press Release: Argen-X Completes First Dosing of ARGX-113 for Severe Autoimmune Disorders". Breda & Ghent.

Organisations Organisation Argen-X N.V. (Argenx) (Euronext + Nasdaq: ARGX)
  Today Argenx SE (Euronext + Nasdaq: ARGX)
  Group Argenx (Argen-X) (Group)
  Organisation 2 Stern Investor Relations Inc. (Stern IR)
Products Product efgartigimod (ARGX-113 SIMPLE antibody)
  Product 2 clinical research
Persons Person Van Hauwermeiren, Tim (Argen-X 201101 CEO before Ablynx BusDev Manager before P&G)
  Person 2 DelGiacco, Beth (Argenx 201806– VP Investor Relations before Stern IR)

> Potential breakthrough therapy for treatment of autoimmune crisis

> Fourth arGEN-X drug candidate entering human trials in 6 years of operations

arGEN-X N.V. (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today announces the completion of the first human dosing of ARGX-113, a potential breakthrough therapy for the treatment of autoimmune crisis.

“The first dosing of healthy volunteers in our Phase 1 study marks an important step forward for ARGX-113. ARGX-113 has a completely novel approach to managing acute crises related to a large number of IgG-mediated autoimmune diseases such as systemic lupus erythematosus as well as a wide range of serious autoimmune orphan diseases for which there are currently insufficient treatment options,” comments Tim Van Hauwermeiren, CEO of arGEN-X. “ARGX-113 demonstrated high potency and rapid onset of action in a preclinical setting and has an exciting potential to treat patients in high unmet medical need”.

The Phase 1 study is a double-blinded and placebo-controlled study in healthy volunteers. The objective is to evaluate the safety and tolerability profile of ARGX-113 and to identify a potential dose for future Phase 2/3 studies. Topline results from the Phase 1 study are expected in the first half of 2016.

About ARGX-113

ARGX-113 is a potential breakthrough therapy for treatment of autoimmune disease crises. ARGX-113 is the Fc-portion of an antibody that has been modified by arGEN-X’s 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 faster clearance of IgG autoantibodies.

About arGEN-X

arGEN-X combines the diversity of the llama immune system with antibody engineering to advance a clinical pipeline to treat patients with cancer and autoimmune diseases. Our platforms allow us to unlock novel and complex targets and develop antibody-based drugs designed for greater efficacy and longer duration of effect. The strength of our team, our deep understanding of the biology, and our committed collaborations with industry leaders contribute to the success of our journey.
arGEN-X is listed on the Euronext Brussels exchange under the symbol ARGX.

SIMPLE Antibody™ and ABDEGTM are trademarks of arGEN-X NV.

For further information, please contact:

Joke Comijn, Corporate Communications Manager
+32 (0)477 77 29 44
+32 (0)9 243 40 70

Beth DelGiacco (US IR)
Stern Investor Relations
+1 212 362 1200

Forward-looking Statements

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “expects”, “intends”, “may”, “will”, or “should”, and include statements arGEN-X makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. arGEN-X’ actual results may differ materially from those predicted by the forward-looking statements. arGEN-X undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.

Record changed: 2017-04-17


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