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Takeda acquires license for investigational celiac therapy

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Takeda Pharmaceuticals has acquired the rights to develop and commercialize an investigational therapy for patients with celiac disease from COUR Pharmaceutical Development Company, the company announced in a press release.

The deal follows positive results of a study presented at UEG Week 2019 that assessed the efficacy of the drug — CNP-101/Tak-101 — in 34 patients with celiac disease.

“While many people living with celiac disease can manage their symptoms by following a gluten free diet, there are currently no treatment options for those who continue to have symptoms,” Asit Parikh MD, PhD, head of the gastroenterology therapeutic area unit at Takeda, said in the release. “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.”

In the study, patients with well-controlled, biopsy proven celiac disease underwent treatment with the drug or placebo, which were administered intravenously at day 1 and day 8. After the second treatment, they underwent a gluten challenge. The primary endpoint was change from baseline in interferon-gamma spot forming units (SFUs) at day 6 after gluten challenge using a gliadin-specific enzyme-linked immunospot (ELISpot) assay.

The primary endpoint was achieved with patients who received the drug experiencing a mean change in interferon-gamma ELISpot SFUs of 2.1 compared with a mean change of 17.57 in patients who received placebo (P = .0056).

“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,” John J. Puisis, CEO of COUR Pharmaceuticals, said in the release. “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.”