Recently, investigators have found a potential way to develop a treatment for celiac disease, which, according to Cour Pharmaceuticals focuses on the autoimmune disease, along with other inflammatory diseases. The treatment has been approved for clinical trials in August, 2017, and these trials have began in four different areas of the United States.
The name of this pharmaceutical treatment is TIMP-GLIA, and it's a procedure that would be used to control celiac disease via patented nanoparticles, which contain small fragments of the gluten protein called “Gliadin”. This protein is known for being able to stimulate the response given by the autoimmune system to adverse conditions triggered by celiac disease. In most cases, this gluten protein passes through the small intestine causing autoimmune responses that trigger severe consequences, such as intestinal cell damage and inflammation.
According to Cour’s research carried out in animal models of celiac disease, gliadin presented in nanoparticles can be encapsulated in fragments and delivered through the blood stream by receiving only one single intravenous dose to the liver, which is the place where T cells are born in the first place. According to experts, it is possible to “fool” the body, especially the immune system, into accepting gliadin as it was a normal part of the diet of a person with celiac disease. Up until now, this process is considered a way to induce immune tolerance.
Clinical trials for TIMP-GLIA and researchers’ expectations
The first two questions people ask themselves about clinical trials for TIMP-GLIA are how long it will last and what kind of results are expected. Most clinical trials follow a standard format divided inn many phases. The first one is designed to assess the tolerability profile and how safe it is to include it in a new therapy for humans.
However, before any new therapy can be tested in a clinic, this treatment must first undergo rigorous testing process in order to determine its level of toxicity, all done according to what is established by the FDA for data evaluation in order to minimize any potential risk. Nevertheless, these tests carried out in labs are not able to fully predict a human being's reaction to these treatments, for that reason the first patients are given a very low dose and are carefully monitored in order to detect any adverse reactions.
If there are no adverse reactions then doses can be increased little by little. In case it is anticipated that there is no adverse response, other patients start taking the medication as well. The dose is usually increased with each additional patient and the cycle is repeated until the standard therapeutic range is reached. Once the planned dosing regimen is achieved, they can start the second phase. According to Cour, the first phase should be completed during this year.
The innovation of TIMP-GLIA for people with celiac disease
Currently, the only effective treatment for celiac disease is following a strict gluten-free diet. Although it is possible, and it has become easier due to the number of gluten-free products available in the current market, many people still find it difficult to completely avoid exposure. This goal is a little impossible to reach, especially since most food today contain a small number of gluten.
In the case of TIMP-GLIA, it works with the patient’s own immune system in order to protect it from adverse reactions triggered by gluten exposure. The tolerance created by small doses of TIMP-GLIA should be able to last for a long time, however, the time the effect will last and other details will depend on each person since the effects vary from person to person.
If someone wants to participate in this clinical trial or in future clinical studies related to this medication, they first have to sign up for Go Beyond Celiac. It's important to note that a successful clinical trial will always depend on finding participants quickly in order to demonstrate the effects of medication in people with celiac disease.
Most companies like Cour Pharmaceuticals go to Beyond Celiac to look for qualified participants for clinical trials, especially since Beyond Celiac’s criteria for selection is the one needed for appropriate patients to participate in researches. It is important to highlight that each clinical trial varies depending on:
- The kind of treatment that is being tested
- How many locations and study locations there are
- Which phase of the testing process is the research undergoing at the moment
While some people may not qualify for a particular study, there are other studies or future phases that may be suitable for each prospect. It is recommended for anyone willing to help or interested on accelerating researches to register at Go Beyond Celiac in order to keep themselves updated with new information.
About Cour Pharmaceuticals
Cour Pharmaceuticals is a specialty pharma company with the main purpose of developing medication for allergic, autoimmune and inflammatory conditions. Due to proper findings and results in animal testing, the FDA has approved their clinical trials in order to look for effective treatment for celiac disease. Apparently encapsulating a component of wheat has shown better results than expected when looking to cause gluten tolerance in animals and people as well.
The findings achieved, thanks to this evaluation, may be helpful for an approximate of 1-3 percent global population known to suffer from celiac disease. Celiac patients who ingest gluten, whether it be on purpose or by accident, have a severe adverse reaction caused by their small intestine since their villi are not able to break down this protein. Also, most severe cases of untreated celiac disease may cause serious medical conditions such as cancer and infertility.
There are currently no medications that can actually prevent the autoimmune attack triggered by gluten consumption, so TIMP-GLIA would be the first significant improvement regarding effective alternatives to a gluten-free diet.