Results of a new phase 2 clinical trial using technology developed by Northwestern Medicine show can promote gluten tolerance to gluten in people with celiac disease. The results could pave the way for treated patients treated to gluten in their diet.
After treatment with the technology, patients were able to eat gluten with a significant reduction in inflammation. The results also show a trend of protecting small intestines of patients from gluten exposure.
The results will be presented in late October 22 at the European Gastroenterology Week conference in Barcelona, Spain.
Nanoparticle is a biodegradable technology that contains gluten that teaches the immune system with the antigen (allergen) safe. The nanoparticle acts as a Trojan horse, hiding the allergen in a friendly shell, to convince the immune system without attacking it.
Outside celiac disease, the result sets out the stage for the technology – a nanoparticle where the antigen is interfering with the allergy or an autoimmune disease – to treat many other diseases and allergies, including multiple sclerosis, type 1 diabetes, peanut allergy, asthma and more.
The technology was developed in the laboratory of Stephen Miller, a professor of microbiology and immunology at Feinberg School of Medicine Northwestern University, who spent many years filtering technology.
“This is the first demonstration of technology in patients,” said Miller, Professor of Microbiology and Immunology Research Judy Gugenheim. “We have also shown that we can include myelin in the nanoparticle to encourage tolerance for this substance in multi-cyclic molds, or to remove protein from pancreatic beta cells to stimulate tolerance in insulin in type 1 diabetes.”
When the nanoparticle loaded by an allergen is inserted into the bloodstream, the immune system does not apply, as it sees the particle as innocent. Then, macrophage wears the nanoparticle and its cargo, basically a cleaner vacuum cell that clears cellular debris and pathogens from the body.
“The vacuum cleaner presents the allergen or antigen in the immune system in a way that says,‘ No worries, this applies, ”Miller said. “Then the immune system reduces its attack on the allergen, and the immune system is usually reset.”
In the celiac disease trial, the nanoparticle was loaded with gliadin, the main element of nutrition gluten, found in cereal grains as wheat. Week after treatment, gluten was given to patients for 14 days. Without treatment, Celiac patients who eat gluten developed immune responses marked on gliadin and damage in their small intestine. Celiac patients treated with nanoparticle showed the COUR, CNP-101, a 90% less response to immune inflammation than untreated patients. By stopping the inflammatory puzzle, CNP-101 showed the ability of the intestines to protect from gluten-related injury.
There is currently no treatment for celiac disease.
“Doctors can not just avoid gluten prescribing, which is not always effective and has a heavy social and economic toll for a celiac patient,” Miller said.
About 1% of the population has celiac disease, a serious autoimmune disease which causes damage in the small intestine due to gluten intake. When people with celiac disease eat gluten (a protein found in wheat), their body implements an immune response that attacks the small intestine.
Autoimmune diseases are generally only treatable with immune suppressors who provide some relief, undermining the immune system and resulting in toxic outcomes. CNP-101 does not prevent the immune system but reverses the disease.
“The celiac disease and many other autoimmune disorders varies because it is well known for the guilty antigen (the environmental stimulus) – gluten in the diet,” said Dr. Medical Center. “This makes celiac disease a perfect condition to tackle using this exciting antibody tolerance approach.” T
Kelly, who will be presenting the research in Barcelona, is working with Miller to implement the technology and define the therapeutic approach to treating celiac disease.
Nanotechnology was licensed to COUR Pharmaceuticals Co., biotechnology based in Northbrook and co-founded by Miller. COUR developed CNP-101, which was given Fast Track status from the US Food and Drug Administration, and brought the therapy to patients in conjunction with Takeda Pharmaceuticals. Takeda Tuesday will announce that they have secured an exclusive global license to develop and commercialize this investigative remedy for celiac disease.
“As a result of the license granted by Takeda, COUR will focus on clinical programs in peanut allergy and multiple sclerosis in the short term and extend it over time,” said John J. Puisis, president and chief executive officer of COUR.
Miller, who is on the scientific advisory board of COUR, is a stock donor and paid advisor to the company. Northwestern University has a financial interest in COUR.
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