Oct. 22 (UPI) — Northwestern Medicine has developed a technology that reduces intolerance to gluten, the new phase 2 clinical trial results show, the university said in a statement on Tuesday.
Celiac disease patients in a phase 2 clinical trial were able to eat gluten with substantially less inflammation after the treatment with the technology.
Celiac disease is a serious autoimmune disease and digestive disorder where people cannot tolerate gluten in wheat, barley, and rye without damaging the small intestine.
The technology consists of a nanoparticle with gluten that “acts like a Trojan horse, hiding the allergen in a friendly shell, to convince the immune system not to attack it,” the statement said.
The findings were presented Tuesday at the European Gastroenterology Week conference in Barcelona, Spain.
For the trial, 34 participants were randomized to receive either placebo or an IV treatment on day 1 and 8, and then given 12 grams of gluten for three days, followed by 6 grams per day for 11 days. Researchers tested the direct measure of T cell activation and immune response, and whether the treatment could prevent it.
Based on the results, the researchers said they plan to start a dose-ranging study ahead of further trials of the treatment.
Stephen Miller, a Northwestern University professor, worked on refining the technology for decades, which he said also has the potential to treat other allergens and diseases — potentially including multiple sclerosis, type 1 diabetes, peanut allergy and asthma, among others.
“This is the first demonstration the technology works in patients,” Miller said in a press release. “We have also shown that we can encapsulate myelin into the nanoparticle to induce tolerance to that substance in multiple sclerosis models, or put a protein from pancreatic beta cells to induce tolerance to insulin in type 1 diabetes models.”
Takeda Pharmaceutical acquired an exclusive global license to “develop and commercialize” the nanoparticle, based on COUR Pharmaceutical’s antigen-specific immune tolerance platform, COUR and Takeda announced in a statement Tuesday.
“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,” said Asit Parikh, head, Gastroenterology Therapeutic Area Unit at Takeda. “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.”