Cour Pharmaceuticals has announced a $420 million licensing deal with Takeda Pharmaceuticals following a favorable outcome of their phase 2 trial for celiac disease. The company released data from a small phase 2a study at the annual United European Gastroenterology organization meeting showing that its treatment, CNP-101, cut levels of inflammation-promoting cytokines. The technology was developed in the lab of Stephen Miller, PhD, professor of microbiology and immunology at Northwestern University Feinberg School of Medicine.
Cour’s treatment is a nanoparticle loaded with gliadin—a component of gluten—that aims to reprogram the immune system so it doesn’t attack the intestines when a person with celiac disease ingests gluten. The study tested this treatment against a placebo in 34 adults with proven celiac disease. The patients received either CNP-101 or the placebo by intravenous infusion on days one and eight of the study and then started a gluten challenge a week after their second dose. Of the 34 patients, 28 finished the trial and six quit due to gluten-related symptoms.
Once in the spleen, the antigen or peptide is released, where it starts to reprogram the immune system, stopping it from attacking the body’s own tissues or mounting a response to an allergen. Patients treated with CNP-101 developed fewer interferon-gamma spot forming units, a direct measure of gluten-specific systemic T-cell activation in celiac disease, than those taking the placebo. The treated patients had less damage to the mucous membrane of their small intestine than placebo patients did, and 90% less immune inflammation response than untreated patients.
Encouraged by the results of the study, Takeda initiated a global license for the program, which now goes by CNP-101/TAK-101. The technology can also potentially be applied to other diseases, such as multiple sclerosis, type 1 diabetes, peanut allergy, asthma, and more.
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