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CNP-101 is a first-in-class, immune-modifying biodegradable nanoparticle therapy containing gliadin proteins. It is designed to induce antigen-specific immune tolerance to gluten in patients with celiac disease. The drug encapsulates gliadin (a component of gluten) within negatively charged poly(dl-lactide-co-glycolic acid) nanoparticles. Upon intravenous administration, these nanoparticles are taken up by antigen-presenting cells and delivered to the spleen where they release the gliadin protein. This process reprograms the immune system to recognize gluten as harmless and prevents activation of pathogenic T cells that drive celiac disease pathology. Clinical trials have shown that CNP-101 significantly reduces gluten-induced interferon-gamma-producing T cell responses and intestinal mucosal damage compared with placebo in adults with well-controlled celiac disease exposed to a controlled oral gluten challenge[1][2][4][5][6]. The technology was originally developed by COUR Pharmaceuticals and later licensed globally by Takeda for further development and commercialization.
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