Takeda and Cour have announced that Takeda has acquired an exclusive global license to develop and commercialize the investigational medicine CNP-101/TAK-101, an immune modifying nanoparticle containing gliadin proteins. Based on Cour's antigen specific immune tolerance platform, TAK-101 is a potential first-in-class treatment targeting the aberrant immune response in celiac disease, an autoimmune disease where the ingestion of gluten leads to inflammation and damage in the small intestine.
Results of a randomized, double-blind, placebo-controlled clinical trial to assess the markers of potential efficacy and safety of the investigational medicine in 34 adults with proven celiac disease was presented today as a late-breaking abstract at UEG Week 2019, Barcelona, Spain. At inclusion, patients had well-controlled biopsy proven celiac disease. After inclusion, they underwent an oral gluten challenge. Based on the study, Takeda exercised its option to acquire the exclusive global license to TAK-101.
In the trial, treatments were administered intravenously on day 1 and day 8. The gluten challenge began seven days after the second treatment administration and included 12 grams of gluten per day for three days followed by 6 grams of gluten per day for 11 days. The primary endpoint was change from baseline in interferon-gamma (IFN-γ) spot forming units (SFUs) at day 6 after gluten challenge using a gliadin-specific enzyme-linked immunospot (ELISpot) assay. This test is a direct measure of gluten-specific systemic T cell activation in celiac disease, and blocking this response suggests individuals with celiac disease could be protected from the effects of gluten exposure.
Takeda intends to initiate a dose-ranging study to further explore the potential of TAK-101 in the treatment of patients with celiac disease on a gluten free diet to inform future registrational trials.
Cour is eligible to receive up to $420 million in future payments, and royalties on sales of any commercialized products resulting from the license.
Read the full Takeda release