Date: 2014-08-19
Type of information: Results
phase: preclinical
Announcement: results
Company: Argen-X (The Netherlands-Belgium)
Product: ARGX-113
Action
mechanism: ARGX-113 is a proprietary antibody fragment based on the company’s ABDEG™ technology, which modulates the process of antibody recycling. ARGX-113 works by preventing pathogenic autoantibodies, i.e. those that target and damage healthy tissues, from being recycled, promoting their degradation and thereby removing, or clearing, them from the circulation.
Disease: autoimmune diseases
Therapeutic area: Autoimmune diseases
Country:
Trial details:
Latest
news: * On August 19, 2014, arGEN-X, a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, announced the results of a preclinical study assessing the pharmacokinetic and pharmacodynamic (PK/PD) behaviors of ARGX-113, the Company’s most advanced autoimmune product candidate. The data proved ARGX-113 to be highly effective in rapidly clearing a tracer antibody from circulation in a dose-dependent manner in non-human primates, thus acting as a surrogate of autoantibody clearance. In this preclinical study, non-human primates were administered with ARGX-113, initially in single escalating doses to study the effects of the drug on tracer antibody and total IgG levels. A subsequent phase was completed with optimized, repeat dosing of ARGX-113 to understand the drug’s effect on total IgG clearance. Single cycle intravenous immunoglobulin (IVIg) was used as the comparator in the study. IVIg is the current standard of care in treating life-threatening flares in autoimmune diseases. In addition to ARGX-113 proving highly effective in rapidly clearing the tracer antibody from circulation in a dose-dependent manner, the following results were seen: - Repeat administration of ARGX-113 showed a rapid, transient depletion of total IgG levels, reaching the desired target range and exceeding the effect observed at a single dose. - Both single and repeat dose administrations of ARGX-113 showed faster and more extensive tracer IgG clearance compared to IVIg. - Total IgA, IgM and serum albumin levels remained unaffected by ARGX-113 treatment. arGEN-X expects to submit a Clinical Trial Application (CTA) for ARGX-113 to the applicable regulatory body in the second half of 2015, proposing the initiation of a Phase 1 study in healthy volunteers to establish safety and tolerability of the drug.
