Nanoparticle technology that has taken decades to develop has shown promising results in a Phase II trial that indicates it may help people with coeliac disease to safely eat gluten.
For the Phase II study, treatment was tested against a placebo in 34 adults with proven coeliac disease. The treatment comprised a novel biodegradable nanoparticle loaded with gliadin, the major component of dietary gluten. The participants received either the loaded nanoparticle or placebo by intravenous infusion on days one and eight of the study and then underwent a gluten challenge a week after their second dose. They ate 12 grams of gluten each day for three days and then 6 grams of gluten each day for 11 days after that. Of the 34 patients, 28 finished the trial and six withdrew due to gluten-related symptoms.
Without treatment, those eating gluten developed marked immune responses to gliadin and damage in their small intestine. Those treated with the nanoparticle showed 90 per cent less immune inflammation response than untreated patients.
Based on these positive findings, Takeda Pharmaceutical Company has acquired the exclusive global licence from Cour Pharmaceuticals in a deal reportedly worth $420m. While Takeda will now develop and commercialize this gliadin-loaded product, Cour Pharmaceuticals will focus on utilising this nanoparticle technology to address other autoimmune disorders and peanut allergy.
See the Takeada Pharmaceuticals press release for full details.