sibeprenlimab   Click here for help

GtoPdb Ligand ID: 12102

Synonyms: VIS-649 | VIS649
Immunopharmacology Ligand
Compound class: Antibody
Comment: Sibeprenlimab (VIS-649) is a fully humanized IgG2κ monoclonal antibody that targets the B-cell growth factor APRIL (TNFSF13) [1,4]. The antibody binds with high affinity to human trimeric APRIL, and potently blocks APRIL binding to its receptors TACI (transmembrane activator and CAML interactor) and BCMA (B-cell maturation antigen). It was developed by Visterra for anti-inflammatory potential.
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Summary of Clinical Use Click here for help
Sibeprenlimab has advanced to phase 3 clinical evaluations, as a mechanism to reduce pathological levels of circulating IgA in patients with IgA nephropathy.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT03719443 First in Human Study to Assess Safety of VIS649 in Healthy Subjects Phase 1 Interventional Visterra, Inc. Data from the first-in-human trial in healthy volunteers indicated that sibeprenlimab is safe and well tolerated. Target engagement was validated by reversible (and dose-dependent) suppression of APRIL levels, and reduction in circulating immunoglobulins (IgA, IgG, IgM). 3
NCT05248659 Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy Phase 2/Phase 3 Interventional Otsuka Pharmaceutical Development & Commercialization, Inc.
NCT05248646 Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN) Phase 3 Interventional Otsuka Pharmaceutical Development & Commercialization, Inc.
NCT04287985 Safety and Efficacy Study of VIS649 for IgA Nephropathy Phase 2 Interventional Visterra, Inc. 2