BREAKING NEWS: Celiac Disease ‘Cure’ Enters Phase 2 Human Trials

The word ‘cure’ is definitely overused on the internet.  Often claims of a cure are just click-bait lies.  In this case however, a ‘cure’ for celiac disease relates to a method of hiding gluten from the body thereby nearly eliminating the immune response.  This one does not feel like hype to us.

At this years United European Gastroenterology Week, after decades of research Chicago’s Northwestern University announced it has developed a what appears to be a commercially viable, biodegradable, nanoparticle that coats gluten so the human immune system does not think it is an allergen.  If it does not think it is an allergen, it does not trigger an immune response:

“…The nanoparticle acts like a Trojan horse, hiding the allergen in a friendly shell, to convince the immune system not to attack it.

…When the allergen-loaded nanoparticle is injected into the bloodstream, the immune system isn’t concerned with it, because it sees the particle as innocuous debris. Then the nanoparticle and its hidden cargo are consumed by a macrophage, essentially a vacuum-cleaner cell that clears cellular debris and pathogens from the body.” SOURCE

Their first human trials are now complete and the results are truly impressive:

“…A week after treatment, the patients were fed gluten for 14 days… Celiac patients treated with the COUR nanoparticle, CNP-101, showed 90% less immune inflammation response than untreated patients. By stopping the inflammatory response, CNP-101 showed the capacity to protect the intestines from gluten related injury.

…’This is the first demonstration the technology works in patients,’ said Steven Miller, the Judy Gugenheim Research Professor of Microbiology and Immunology. SOURCE

On October 16th, Japan’s Takeda Pharmaceutical Company Limited announced it has acquired the exclusive global rights to “CNP-101/TAK-101”:

“…Results of a randomized, double-blind, placebo-controlled clinical trial to assess the markers of potential efficacy and safety of the investigational medicine in 34 adults with proven celiac disease was presented today as a late-breaking abstract at UEG Week 2019, Barcelona, Spain. At inclusion, patients had well-controlled biopsy proven celiac disease. After inclusion, they underwent an oral gluten challenge. Based on the study, Takeda exercised its option to acquire the exclusive global license to TAK-101.”  SOURCE

Takeda is a real company that is publicly traded on both the Toronto Stock Exchange and the New York Stock Exchange.

Even better, Northwestern thinks this technology can be used to solve (better word than ‘cure’) sources of Multiple Sclerosis and other autoimmune diseases:

“…’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.’

“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,” said John J. Puisis, president and chief executive officer of COUR.  SOURCE

However, researcher are quick to caution against over exuberance for its applications to diseases other than celiac:

“…’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. SOURCE

Who Is Stephen Miller?

We lifted this short biography from the Myeline Repair Foundation:

“Dr. Stephen Miller is the Judy Gugenheim Research Professor of Biomedical Sciences, Professor of Microbiology-Immunology and Director of the Interdepartmental Immunobiology Center at Northwestern University.

Dr. Miller’s laboratory investigates the immunological, cellular and molecular mechanisms of T cell-mediated autoimmune responses employing two mouse models of multiple sclerosis – Theiler’s virus-induced model of multiple sclerosis and Relapsing Experimental Autoimmune Encephalomyelitis (R-EAE). The laboratory examines the mechanisms whereby self-tissue destruction results in activation and recruitment of autoreactive T/B cells specific for endogenous self antigens and molecular mimicry, the process that leads to induction and/or progression of autoimmunity.

Dr. Miller’s expertise in the pathogenesis of autoimmunological disorders along with his specific expertise on the role of leukocytes in the regulation of myelination are critical to the Myelin Repair Foundation achieving a comprehensive understanding of the endogenous molecular signals that mediate pathogenesis and prevent remyelination in multiple sclerosis…”  SOURCE

So What Is The Hold Up; Lets Get This Cure On The Market!

Proving a technology in lab animals and then a small human test group is wildly encouraging:

“…In the United States, it takes an average of 12 years for an experimental drug to travel from the laboratory to your medicine cabinet.  That is, if it makes it.  Only 5 in 5,000 drugs that enter preclinical testing progress to human testing.” SOURCE

However, many important hurdles remain.  Only 1 of the 5 drugs that get to human testing actually makes it to market.  This is because:

1. large scale ‘real’ testing shows that the drug is less effective than required to be marketable
2. complications or negative drug interactions may kill the product
3. costs may make the drug unmarketable
4. sometimes other drugs get developed or repurposed in the interim that makes the new drug unmarketable

We at MyCeliacWorld.com have very high hopes for this and other celiac research but we expect it is going to be a few years before we jump up and down at the Olive Garden.