sibeprenlimab (VIS649) / Otsuka 
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  • ||||||||||  sibeprenlimab (VIS649) / Otsuka, Fabhalta (iptacopan) / Novartis, Rituxan (rituximab) / Roche
    Review, Journal:  Biologics and Non-Biologics Immunosuppressive Treatments for IgA Nephropathy in Both Adults and Children. (Pubmed Central) -  May 11, 2024   
    Recent developments of new biologics, including anti-BAFF/APRIL inhibitors and molecules targeting complement components, offered the opportunity to selectively target immune cell subsets or activation pathways, leading to more effective and safer hypothesis-driven treatments. However, studies testing new biologic agents in IgAN should also consider paediatric populations to address the unique needs of children and close the therapeutic gap between adult and paediatric care.
  • ||||||||||  sibeprenlimab (VIS649) / Otsuka
    Review, Journal:  Sibeprenlimab, which neutralizes a PRoliferation inducing ligand (APRIL), as a new approach to treating IgA nephropathy. (Pubmed Central) -  Apr 20, 2024   
    P2
    The pharmaceutical company behind sibeprenlimab is also developing it for subcutaneous use, which would have advantages over intravenous use. As IgA nephropathy is a long-term progressive disease, key questions that need to be answered, over a long-time course, with sibeprenlimab are (i) whether its safety is maintained, and (ii) whether it improves clinical outcomes.
  • ||||||||||  sibeprenlimab (VIS649) / Otsuka
    P2 data, Journal:  Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy. Reply. (Pubmed Central) -  Apr 14, 2024   
    As IgA nephropathy is a long-term progressive disease, key questions that need to be answered, over a long-time course, with sibeprenlimab are (i) whether its safety is maintained, and (ii) whether it improves clinical outcomes. No abstract available
  • ||||||||||  Filspari (sparsentan) / Travere Therap, sibeprenlimab (VIS649) / Otsuka
    Review, Journal:  Immunoglobulin (Pubmed Central) -  Mar 25, 2024   
    No abstract available While systemic corticosteroids are now only indicated in rare cases, a
  • ||||||||||  Review, Journal:  A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP). (Pubmed Central) -  Nov 13, 2023   
    Sibeprenlimab rapidly and sustainably reduced target APRIL and Ig biomarkers in a dose-dependent and reversible manner, with acceptable preliminary safety and pharmacokinetics. Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab.
  • ||||||||||  Sibeprenlimab (VIS649) / Otsuka
    Trial completion:  Safety and Efficacy Study of VIS649 for IgA Nephropathy (clinicaltrials.gov) -  Oct 27, 2023   
    P2,  N=155, Completed, 
    Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab. Active, not recruiting --> Completed
  • ||||||||||  Review, Journal:  Emerging role of monoclonal antibodies in the treatment of IgA nephropathy. (Pubmed Central) -  May 15, 2023   
    New treatment options are aimed at the immunopathogenesis of IgAN including depletion or modulation of Gd-IgA1 producing B cells, plasma cells, alternate or lectin pathway of complement. Monoclonal antibodies may target both B cells and T cells and also the factor needed for their activation and survival, e.g BAFF or APRIL.
  • ||||||||||  Sibeprenlimab (VIS649) / Otsuka
    Enrollment open:  Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (clinicaltrials.gov) -  Mar 10, 2023   
    P2/3,  N=600, Enrolling by invitation, 
    A Phase 3 trial of sibeprenlimab in this patient population (NCT05248646) is open and enrolling patients. Active, not recruiting --> Enrolling by invitation
  • ||||||||||  Sibeprenlimab (VIS649) / Otsuka
    Enrollment closed, Trial completion date, Trial primary completion date:  Safety and Efficacy Study of VIS649 for IgA Nephropathy (clinicaltrials.gov) -  Mar 28, 2022   
    P2,  N=155, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Nov 2022 --> Jun 2023
  • ||||||||||  Sibeprenlimab (VIS649) / Otsuka
    Enrollment open:  Safety and Efficacy Study of VIS649 for IgA Nephropathy (clinicaltrials.gov) -  Jul 20, 2020   
    P2,  N=144, Recruiting, 
    Thus, our data highlight the potential therapeutic benefit of VIS649 for the treatment of IgAN. Not yet recruiting --> Recruiting
  • ||||||||||  Sibeprenlimab (VIS649) / Otsuka
    Trial initiation date:  Safety and Efficacy Study of VIS649 for IgA Nephropathy (clinicaltrials.gov) -  May 22, 2020   
    P2,  N=144, Not yet recruiting, 
    Not yet recruiting --> Recruiting Initiation date: Mar 2020 --> Jul 2020
  • ||||||||||  Sibeprenlimab (VIS649) / Otsuka
    Trial completion date, Trial primary completion date:  First in Human Study to Assess Safety of VIS649 in Healthy Subjects (clinicaltrials.gov) -  Mar 6, 2020   
    P1,  N=41, Completed, 
    Initiation date: Mar 2020 --> Jul 2020 Trial completion date: May 2015 --> Aug 2019 | Trial primary completion date: May 2015 --> Aug 2019
  • ||||||||||  Sibeprenlimab (VIS649) / Otsuka
    Trial completion, Trial initiation date:  First in Human Study to Assess Safety of VIS649 in Healthy Subjects (clinicaltrials.gov) -  Oct 6, 2019   
    P1,  N=41, Completed, 
    Trial completion date: May 2015 --> Aug 2019 | Trial primary completion date: May 2015 --> Aug 2019 Recruiting --> Completed | Initiation date: Oct 2018 --> Sep 2014