A potential treatment for celiac disease has been approved for clinical trials
A potential treatment for celiac disease developed by Cour Pharmaceuticals has been approved for clinical trials beginning at four sites in the United States. The specialty pharmaceutical company, which focuses on autoimmune, allergic and inflammatory diseases, using its patented nanoparticles called TIMP-GLIA received approval for Phase 1 trails from the U.S. Food and Drug Administration (FDA) in August.
What is TIMP-GLIA and how does it work to control celiac disease?
TIMP-GLIA is shorthand for the patented nanoparticles developed by Cour Pharmaceuticals that contain fragments of the gluten protein gliadin, which has been shown to stimulate the autoimmune response in celiac disease. Normally these fragments of gliadin pass through the intestinal wall and activate the immune response, causing inflammation and intestinal cell damage. However, based on Cour’s research in animal models of celiac disease, by encapsulating fragments of gliadin in nanoparticles and delivering them through the blood stream (via a single intravenous dose) to the liver and spleen where immune T cells are born, the immune system can be fooled into accepting gliadin as a normal part of our diet. This process is referred to as inducing immune tolerance.
What does Cour expect to learn from its Phase 1 clinical trial and how long will it last?
Clinical trials generally follow a standard format. Phase 1 is designed to assess the safety and tolerability profile of a new therapy in humans. Before any new therapy can be tested in the clinic it must first undergo a rigorous battery of toxicity testing and data evaluation by the FDA to minimize any potential risk. However, testing in the laboratory can never fully predict human response. Therefore, in the clinic, the first patient receives a very low dose and is monitored closely for any adverse reactions. If, as anticipated, there is no adverse response, then the dose is increased with each additional patient until the normal therapeutic range is reached. Finally, patients are given multiple doses to match the actual planned dosing regimen. Cour expects the Phase 1 study to be completed in 2018.
How is TIMP-GLIA different from the Gluten-Free Diet?
Removal of gluten from the diet is currently the only treatment for celiac disease. Most people with celiac disease find it difficult, if not impossible, to completely avoid all gluten exposure, making the gluten-free diet an imperfect treatment. TIMP-GLIA works with the patient’s own immune system, to protect them from adverse reactions to gluten exposure once immune tolerance is established. This tolerance should last for a prolonged period of time. The efficacy of the effect, how long the effect will last, and if they will vary from person to person will be part of future clinical studies.
What is the best way to participate in this clinical trial or future clinical studies?
First and formost, sign up for Go Beyond Celiac. A successful clinical trial depends on finding the right participants quickly. Companies, such as Cour Pharmaceuticals, frequently come to Beyond Celiac when they want to find qualified participants for their clinical trials because we understand how important this is and can connect interested and appropriate celiac disease patients with researchers. Every study has specific selection criteria, both for inclusion and exclusion, that are unique to:
- the treatment being tested
- the phase of testing being conducted
- the number and location of the study sites
While you may not qualify for a particular study because you do not live near a current study site or you do not meet the current study criteria, that does not mean you would not be eligible for future studies or the next phase of this study.
The best way to find out about future clinical trials is to register at Go Beyond Celiac so we have the most up-to-date information to match you with future studies.
Help advance celiac disease research by becoming involved at Go.BeyondCeliac.org, a new meeting place for patients, healthcare providers and scientists.
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