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rCTB-401 is a recombinant version of the cholera toxin B subunit (rCTB), a non-toxic protein that serves as a potent mucosal immunomodulator. Developed by SBL Vaccin AB (later acquired by Crucell), rCTB-401 was investigated for the treatment of active Crohn's disease. Its mechanism of action involves high-affinity binding to GM1 ganglioside receptors on the surface of intestinal epithelial cells and immune cells, which promotes the induction of mucosal tolerance and modulates the production of inflammatory cytokines. In a pilot Phase 2 clinical trial conducted in Sweden, rCTB-401 was administered orally to adult patients with active Crohn's disease to evaluate its safety, tolerability, and clinical efficacy.
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