Takeda Pharmaceutical has obtained exclusive, worldwide rights for the development and commercialisation of COUR Pharmaceutical Development’s drug candidate for coeliac disease.

CNP-101 / TAK-101 is an investigational immune modifying nanoparticle made of gliadin proteins. It is designed using COUR’s immune tolerance platform to target the immune response associated with coeliac disease.

Coeliac disease is an autoimmune disorder characterised by gluten ingestion resulting in inflammation and damage in the small intestine. Patients typically manage their symptoms by avoiding gluten.

However, the disease currently lacks treatments for patients whose symptoms continue.

Takeda Pharmaceutical 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 coeliac 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 coeliac disease.”

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Takeda exercised its option to buy the licence to TAK-101 comes from results of a randomised, double-blind, placebo-controlled clinical trial that evaluated intravenous formulation of the drug candidate given on days one and eight.

The study involved 34 patients who took a gluten challenge at seven days following the second administration. During the trial, participants received 12g of gluten each day for three days, followed by 6g per day for 11 days.

The primary endpoint of the trial was the change in interferon-gamma (IFN-γ) spot forming units (SFUs) from baseline at day 6 post-gluten. It was measured using a gliadin-specific enzyme-linked immunospot (ELISpot) assay for gluten-specific systemic T-cell activation.

Of the total participants, six discontinued because of gluten symptoms, while the remaining 28 completed the 14-day gluten challenge.

The trial met the primary endpoint, where TAK-101 showed a mean change of 2.10 in IFN-γ ELISpotSFUs from baseline, compared to 17.57 in the placebo arm.

Takeda plans to launch a dose-ranging study of TAK-101 in celiac disease patients on a gluten-free diet. Data from this study is expected to inform future registrational trials.

The company will pay up to $420m to COUR in the future, along with sales royalties on commercialised therapies resulting from the licence.