Nearly 1% of Canadians are affected by celiac disease (CD), an autoimmune disorder where the immune system reacts to gluten and damages the villi of the small intestine. The current standard treatment is life-long adherence to a gluten-free diet, which can carry a heavy social and economic burden.
Takeda Pharmaceuticals recently acquired the license to CNP-101/TAK-101, a first-in-class immune-modifying nanoparticle containing gliadin proteins (a component of gluten). In a randomized, double-blind, placebo-controlled Phase II trial, patients with well-controlled, biopsy-proven CD were treated intravenously on days 1 and 8. Starting on day 13, patients were challenged with a 14-day period of regulated gluten consumption.
Six days following the gluten challenge, the mean change from baseline in interferon-γ spot forming units (IFN-γ SFUs) was determined using a gliadin-specific immunospot (ELISpot) assay. This test measures gluten-specific systemic T-cell activation and blocking this response suggests patients with CD could be protected from the effects of gluten exposure. The mean change from baseline IFN-γ SFUs was 2.1 for patients treated with CNP-101/TAK-101 and 17.57 for those treated with placebo. These results indicate patients treated with CNP-101/TAK-101 had a significantly reduced immune response to gluten, compared to placebo.
Takeda plans to initiate a dose-ranging study to further explore the potential of this immune-reprogramming therapy for patients with CD.