COUR will be eligible to receive the amount from the Japanese company in the form of future payments, and royalties on sales of any commercialised products emerging from the TAK-101 license.
TAK-101, which is an immune modifying nanoparticle that contains gliadin proteins, is being developed for the treatment of celiac disease. Considered to be a serious autoimmune disease, celiac disease is a condition in which the ingestion of gluten results in inflammation and damage in the small intestine.
The investigational drug has been developed on COUR’s antigen-specific immune tolerance platform. It has been designed to target the aberrant immune response in celiac disease.
Takeda gastroenterology therapeutic area unit head Asit Parikh said: “Our collaboration with COUR has shown, for the first time, that it is possible to induce specific immune tolerance to a foreign antigen in autoimmune diseases such as celiac disease.
“With our expertise in inflammatory diseases, Takeda is well positioned to further develop TAK-101 in pursuit of providing the first approved treatment option for patients with celiac disease.”
The licensing deal was signed following positive results from a phase 2a proof-of-concept study of the investigational drug.
The mid-stage trial evaluated the markers of potential efficacy and safety of the investigational drug in 34 adults with proven celiac disease.
As part of the trial, the enrolled patients went through an oral gluten challenge.
The trial’s primary endpoint was met, which was change from baseline in interferon-gamma (IFN-γ) spot forming units (SFUs) at day six following the gluten challenge using a gliadin-specific enzyme-linked immunospot (ELISpot) assay.
COUR CEO John Puisis said: “We are encouraged by the data from this first human proof of concept study of our proprietary nanoparticle platform designed to reprogram the immune system.
“As Takeda assumes responsibility for the celiac disease program, COUR will focus on advancing our pipeline of therapies for a variety of other immune disorders ranging from multiple sclerosis to peanut allergy.”
Takeda plans to launch a dose-ranging trial to further investigate the potential of TAK-101 in patients with celiac disease on a gluten-free diet.