Annexon, Inc. Completes Evaluation of Drug-Drug Interaction Study of Anx005 Co-Administered with Intravenous Immunoglobulin in 14 Patients with GBS
March 25, 2021 at 07:20 am EDT
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Annexon, Inc. completed evaluation of its drug-drug interaction study of ANX005 co-administered with Intravenous Immunoglobulin in 14 patients with GBS. The DDI study was conducted to evaluate the safety and tolerability of ANX005 and IVIg co-administration in GBS patients, and measured pharmacokinetics (PK) and pharmacodynamics (PD) of ANX005 when administered in combination with IVIg. IVIg, though not FDA-approved in the United States for GBS, is currently the standard of care for GBS. Initial results from the DDI study included: Co-administration of IVIg-ANX005 was well-tolerated. Co-administration of IVIg-ANX005 achieved full C1q target engagement, and C1q suppression was maintained within the targeted range. The open-label DDI study was not placebo-controlled or powered for statistical significance on efficacy measures. A number of key GBS outcome measures were recorded from baseline, and early improvement was observed in GBS patients, including increased muscle strength, decreased neurofilament light chain (NfL) and improved GBS disability score. Full results from the DDI study are expected to be submitted to a peer-reviewed forum in 2021. A placebo-controlled Phase 2/3 trial is ongoing to evaluate the efficacy of ANX005 monotherapy in improving disability in GBS patients. Data from the Phase 2/3 trial is anticipated in 2023. ANX007 in Geographic Atrophy. In February 2021, the company initiated a Phase 2 trial evaluating the efficacy of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA, which includes monthly and every other month dosing of ANX007. Data from this trial is anticipated in 2023.
Annexon, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in advancing a late-stage clinical platform of therapies for people living with classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Using its platform, it is identifying and characterizing the role of the complement pathway in three therapeutic areas: autoimmune, neurodegeneration and ophthalmology. Its lead candidate, ANX005, is an investigational monoclonal antibody (mAb), formulated for intravenous administration in a pivotal Phase III clinical trial for the treatment of patients with Guillain-Barre Syndrome (GBS). It is evaluating ANX007, an antigen-binding fragment (Fab), formulated for intravitreal administration, for the potential treatment of patients with geographic atrophy (GA). It is developing ANX1502, which is an oral small molecule for the treatment of autoimmune indications. It has developed ANX009, a C1q-blocking Fab formulated for subcutaneous delivery.
ANNEXON, INC. 
