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Synonyms: VIS-649 | VIS649
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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| No information available. |
Summary of Clinical Use  |
| 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 | |
