argenx Announces “GO” Decision in ADHERE Trial of Efgartigimod in Chronic Inflammatory Demyelinating Polyneuropathy Following Interim Analysis - Seite 2

The company will host a conference call today at 2:30 p.m. CET (8:30 a.m. ET) to discuss the decision to continue enrollment in ADHERE.

Dial-in numbers: 
Please dial in 15 minutes prior to the live call. 

Belgium	0800 389 13
France	0805 102 319
Netherlands	0800 949 4506
United Kingdom	0800 279 9489
United States	1 844 808 7140
International	1 412 902 0128

A live webcast of the presentation will be available on the Company’s website at www.argenx.com. A replay of the webcast will be available for approximately 1 year following the presentation.

ADHERE Trial Design

The ADHERE trial is a randomized, withdrawal study evaluating 1000mg weekly subcutaneous (SC) efgartigimod for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The trial consists of an open-label Stage A followed by a randomized, placebo-controlled Stage B with a planned interim responder analysis after the first 30 patients enroll in Stage A. In order to enter Stage A and receive efgartigimod, both patients who were treatment-naïve or on therapy must first receive a confirmed diagnosis of CIDP by an independent panel of experts and demonstrate active disease. To show active disease, patients who are on current CIDP therapy have to demonstrate a minimal clinically meaningful worsening after treatment withdrawal based on at least one CIDP clinical assessment tool, including INCAT, iRODS, or mean grip strength. To advance to Stage B, patients need to demonstrate a minimal clinically meaningful response to efgartigimod equivalent with the loss observed on the same efficacy scale on which worsening is observed during the withdrawal period. In Stage B, patients are randomized to either SC efgartigimod or placebo for up to 48 weeks. The primary endpoint is event-driven and based on the adjusted INCAT efficacy score in Stage B.  

About Efgartigimod

Efgartigimod is an investigational antibody fragment designed to reduce disease-causing immunoglobulin G (IgG) antibodies and block the IgG recycling process. Efgartigimod binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels representing a logical potential therapeutic approach for several autoimmune diseases known to be driven by disease-causing IgG antibodies, including: myasthenia gravis (MG), a chronic disease that causes muscle weakness; pemphigus vulgaris (PV), a chronic disease characterized by severe blistering of the skin; immune thrombocytopenia (ITP), a chronic bruising and bleeding disease; and chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disease leading to impaired motor function. The subcutaneous formulation of efgartigimod is co-formulated with Halozyme’s ENHANZE drug delivery technology and is administered as a 1000mg weekly single injection.