A new study released by Northwestern Medicines has indicated that it may be possible to reverse celiac disease.
The results of a new phase 2 clinical trial using technology by the company were released to the public in October, showing a new path to induce immune tolerance to gluten.
In turn, this would pave the way for treating celiac patients to eventually tolerate gluten within their diet without the uncomfortable symptoms that so many experience on a daily basis.
Northwestern Medicine tested the technology on patients with celiac disease and found that patients were able to consume gluten while showing a significant reduction in inflammation of the body.
The technology, a biodegradable nanoparticle-containing gluten, teaches the immune system that gluten is safe to prevent the body from attacking it. Described by NM as acting like a ‘Trojan horse,’ the nanoparticle hides the allergen in a body-friendly shell.
Results of testing also indicated a trend toward protecting patients’ small intestine from gluten exposure. The findings were presented as a late-breaking presentation at the European Gastroenterology Week conference in Barcelona, Spain, on October 22.
It is thought that the work could even set the stage for nanoparticles containing the antigen triggering the allergy or autoimmune disease to treat a host of other diseases and allergies. The technology could help patients struggling with multiple sclerosis, type 1 diabetes, peanut allergies, asthma and more.
The history of celiac disease is long, and many have looked to treat it in the past. In 1914, Sidney Haas successfully treated eight children whom he had diagnosed with celiac disease and anorexia with the use of bananas- inspired by previous success with patients suffering from anorexia.
Out of the 10 cases he treated, eight of them were classified as ‘clinically cured’, while the remaining two died.
Today’s new technology was developed in the lab of Stephen Miller, a professor of microbiology and immunology at Northwestern University Feinberg School of Medicine, who has spent decades refining the technology ready for testing.
In a Northwestern statement, Miller said: “This is the first demonstration the technology works in patients.”
“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.”
The allergen-loaded nanoparticle is injected into the bloodstream and is seen by the body as innocuous debris. This effectively makes the nanoparticle a carrier of “hidden cargo,” allowing the gluten to be consumed by a macrophage – a vacuum-cleaner cell that clears cellular debris and pathogens from the body.
Miller added, “The vacuum-cleaner cell presents the allergen or antigen to the immune system in a way that says, ‘No worries, this belongs here’.”
“The immune system then shuts down its attack on the allergen, and the immune system is reset to normal.”
In the celiac disease trial, the nanoparticle was loaded with the major component of dietary gluten, gliadin, found in cereal grains such as wheat. Following treatment with the nanoparticle, patients were fed gluten-containing foods for 14 days.
Those who had not had the treatment-experienced marked immune responses to gliadin and damage in their small intestine. Celiac patients treated with the nanoparticle, however, had 90% less immune inflammation than those untreated. The nanoparticle, CNP-101, had proved its capacity to protect the intestines from gluten-related injury.
Celiac disease has a long history and currently affects around 1% of the population. There is no cure available, only treatments to reduce inflammation through diet or to tamp down the immune system response using immunosuppressant drugs.
Out of the 1%, one in every 100 children in the US also has celiac disease. Left untreated, the autoimmune disease can lead to irreversible damage to the small intestine and interfere with the absorption of nutrients from food. For this reason, many children are also put on a highly restrictive diet.
Miller, however, believes that avoidance doesn’t always help a patient. He said: “Doctors can only prescribe gluten avoidance, which is not always effective and carries a heavy social and economic toll for celiac patients.”
And, in fact, even foods labeled gluten-free are often not guaranteed to be entirely free of gluten – and that’s just one of the many celiac disease myths out there.
While autoimmune diseases are generally only treated with suppressants that stop the immune system – and inflammatory – response, this can lead to toxic side effects. CNP-101, on the other hand, reverses the course of the disease rather than reducing the body’s response to gluten.
Dr. Ciaran Kelly, professor of medicine at Harvard Medical School and director of the Celiac Center at Beth Israel Deaconess Medical Center, shared in his approval of the method.
He said, “Celiac disease is unlike many other autoimmune disorders because the offending antigen (environmental trigger) is well known — gluten in the diet.”
“This makes celiac disease a perfect condition to address using this exciting nanoparticle-induced immune tolerance approach.”
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Kelly, who has been working with Miller to apply the technology and test its approach, presented the research in Barcelona.
The nanotechnology is licensed to COUR Pharmaceuticals Co., a biotech based in Northbrook, Illinois. COUR developed CNP-101, which was granted Fast Track status from the U.S. Food and Drug Administration thanks to its impressive effects on the body.
The therapy has also been given to patients in collaboration with Takeda Pharmaceuticals. Takeda has acquired an exclusive global license to develop and commercialize the investigational medicine for celiac disease.
John J. Puisis, president and chief executive officer of COUR, said: “Given the license by Takeda, COUR will focus on clinical programs in peanut allergy and multiple sclerosis in the near term and broaden even further over time.”