Drug intelligence / Profile preview

budesonide + telitacicept

Development stage
Preclinical
Lead developer
RemeGen
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Small Molecules
Administration
Oral, Subcutaneous
01

Overview

budesonide + telitacicept (telitacicept + Nefecon) is an investigational combination regimen being evaluated for the treatment of IgA nephropathy (IgAN). The regimen combines telitacicept, a recombinant fusion protein (TACI-Fc) developed by RemeGen that dual-targets and neutralizes the B-cell survival cytokines B-lymphocyte stimulator (BLyS/BAFF) and a proliferation-inducing ligand (APRIL), with Nefecon (Tarpeyo/Kinpeygo), a targeted-release oral formulation of the glucocorticoid budesonide developed by Calliditas Therapeutics (now part of Asahi Kasei). While telitacicept acts systemically to inhibit B-cell maturation and reduce pathogenic galactose-deficient IgA1 (Gd-IgA1) production, Nefecon acts locally in the distal ileum to target Peyer's patches, suppressing mucosal B-cell activation at the disease's origin. This dual-targeting approach is being explored in real-world clinical settings to provide synergistic efficacy in reducing proteinuria and stabilizing renal function in high-risk IgAN patients.

Other names
telitacicept + budesonidetelitacicept + budesonide ECtelitacicept + Kinpeygotelitacicept + Nefecontelitacicept + Tarpeyotelitacicept + TRF-budesonide
02

Targets

FcγR (Low affinity immunoglobulin gamma Fc region receptor II-c)GR (Glucocorticoid receptor)BCMA (Tumor necrosis factor receptor superfamily member 17)TNFSF13 (APRIL)BAFF (Tumor necrosis factor ligand superfamily member 13B)

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