“To our knowledge, this is the first clinical trial to demonstrate induction of antigen specific immune tolerance in any autoimmune disease”
– Ciaran Kelly, MD, Professor of Medicine at Harvard Medical School
COUR has developed CNP-101, a biodegradable nanoparticle encapsulating gliadin proteins – the major component of dietary gluten. CNP-101 is the first agent to induce antigen-specific immune tolerance in any autoimmune disease.
In a Phase 2, double-blind, placebo-controlled clinical trial, patients with celiac disease were treated with CNP-101 and, starting one week later, were fed wheat gluten for 14 days. While patients receiving placebo developed severe immune responses to gliadin and damaging inflammation in their small intestine, patients treated CNP-101 showed significantly less inflammation. In addition, CNP-101 showed a trend toward protecting the intestines from gluten-related injury when compared to untreated patients.
Based on these Phase 2 clinical results, Takeda acquired the license to CNP-101 in October 2019 and will lead further clinical development.