New Treatment May Reverse Celiac Disease: Clinical Trial

Bread could someday be back on the menu for people with celiac disease following a potentially major treatment advancement.

On Oct. 22, a research team from Chicago’s Northwestern University shared findings from a phase 2 clinical trial in a late-breaking presentation during a medical conference in Spain.

Phase 2 trials are used to determine the effectiveness of a drug or treatment, as opposed to Phase 1 trials where a treatment’s safety is considered. In this case, researchers tested a new technology developed in the lab of Dr. Stephen Miller, a professor of microbiology and immunology at Northwestern University’s Feinberg School of Medicine. Miller has spent decades refining a biodegradable nanoparticle with potential to treat a host of other diseases in addition to celiac, such as multiple sclerosis, type 1 diabetes, peanut allergy and more.

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About 1% of the population has celiac disease, a serious autoimmune disease where eating gluten leads to damage in the small intestine. When people with celiac disease eat gluten (a protein found in wheat), their body mounts an immune response that attacks the small intestine.

Nanoparticles are microscopic particles that have been studied intensively over the past few years. Recent advances have shown the potential for major applications in the field of bio-medicine.

The nanoparticle developed by Miller’s team contains gluten. When ingested it teaches a person’s immune system that the allergen is, in fact, safe. According to Northwestern University: “The nanoparticle acts like a Trojan horse, hiding the allergen in a friendly shell, to convince the immune system not to attack it.”

This is potentially exciting news for people with celiac.

It’s the first time the technology has been demonstrated to work in patients. Essentially, the study found that after treatment, patients in the study could ingest gluten with a substantial reduction in inflammation. The results also revealed a trend where patients’ small intestines were protected from gluten exposure.

Specifically, the treatment is called CNP-101/TAK-101. In the study, the nanoparticles were administered to celiac patients intravenously on the first and eighth days. After a week, they consumed gluten for 14 days, and their reactions to the gluten were then tested. The trial showed that those who received the treatment showed 90% less immune inflammation response to gluten compared to a group who received a placebo (inactive treatment). The study included 34 participants, six of whom did not complete the trial in light of gluten-related symptoms.

According to Northwestern: “Autoimmune diseases generally can only be treated with immune suppressants that provide some relief, but undermine the immune system and lead to toxic side-effects. CNP-101 does not suppress the immune system but reverses the course of disease.”

“Celiac disease is unlike many other autoimmune disorders because the offending antigen (environmental trigger) is well known – gluten in the diet,” said Dr. Ciaran Kelly, professor of medicine at Harvard Medical School and director of the Celiac Center at Beth Israel Deaconess Medical Center, in a press release. “This makes celiac disease a perfect condition to address using this exciting nanoparticle induced immune tolerance approach.”

Recently, a Japanese pharmaceutical company, Takeda, purchased the license to use the technology specifically to treat celiac disease. Miller and the company he co-founded, COUR Pharmaceutical Development Company, retains ownership of the technology.

Currently, there is no treatment for celiac disease, a gluten-free diet being the most effective way to avoid symptoms.

While the results show some promise for new treatment options, it’s important to note that it’s too soon to expect a cure until further studies are completed.

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