Cour Pharmaceuticals, a specialty pharma company focused on autoimmune, allergic, and inflammatory diseases, announces that its Investigational New Drug (IND) for TIMP-GLIA is now open with the US Food & Drug Administration (FDA).
TIMP-GLIA is a new nanoparticle-based therapeutic for the treatment of celiac disease. By encapsulating a component of wheat within a nanoparticle, Cour developed a novel treatment that resulted in gluten tolerance in numerous animal models. Now, with the IND open, Cour is entering human trials.
The safety and tolerability study of TIMP-GLIA is currently underway in patients with celiac disease in the United States.
About Celiac Disease
Celiac disease is a genetic autoimmune disorder that affects approximately 1-3% of the global population. When a person with celiac disease eats food containing or even contacting gluten (a protein found in wheat) certain cells of the immune system trigger an immune response. This response leads to damage of the small intestine, particularly on the small fingerlike projections that line the small intestine, called villi. Villi of the intestine promote absorption of nutrients from meals. When the villi get damaged, nutrients cannot be absorbed into the body properly. While the acute symptoms of celiac disease may include diarrhea, pain, and fatigue, the intestinal damage can also lead to more severe medical conditions including infertility and cancer.
No medication exists that can prevent the immune attack or allow repair of the damage to the villi resulting from gluten exposure. Current treatment is limited to maintaining a life-long gluten-free diet which can be socially isolating and logistically difficult because the risk of inadvertent exposure to gluten is everywhere – at a restaurant, school cafeteria, or friend’s home.
Using Cour’s novel technology for TIMP-GLIA, the body’s immune system is reprogrammed to tolerate gluten as a non-threatening substance and subsequently abrogates/reverses the signs and symptoms of celiac disease without using immune suppressing drugs. By encapsulating a component of wheat in a nanoparticle Cour developed a “back door” approach, whereby the gluten is not recognized by the body’s immune system until it reaches the spleen, where immune tolerance can be generated through non-inflammatory antigen presentation.
About the Trial for TIMP-GLIA
The clinical trial for TIMP-GLIA study is being conducted at centers in the United States. The objective of the study is to assess the safety and tolerability of TIMP-GLIA when administered intravenously (IV) as a single dose at ascending dose levels and as a repeat dose in subjects with celiac disease.
To learn more:
- Call a recruitment coordinator at ICON: 1-877-848-7425.
- Read more about the trial at: Cour TIMP-GLIA Clinical Trial and ICON Clinical Trials
About Cour Pharmaceuticals
We are a group of dedicated scientific, medical, and business professionals who are driven to find treatments and cures to a variety of diseases. By attacking the disease directly with our novel immune modifying particle technology and working strategically with our medical and scientific partners we seek to provide treatments and cures previously unavailable to doctors and their patients. Please visit https://www.courpharma.com/ for more information.