Cour Pharmaceuticals Receives FDA Fast Track Designation for TIMP-GLIA – A Novel Treatment for Celiac Disease under Clinical Development
- TIMP-GLIA is designed to enable patients to develop tolerance to gluten
- Phase 1 program studying potential of new treatment option for people living with Celiac Disease
CHICAGO, Wednesday, January 10, 2018
Cour Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for TIMP-GLIA, a new nanoparticle-based therapeutic being studied for the treatment of Celiac Disease. By encapsulating a component of wheat within a nanoparticle, Cour is developing a novel treatment which resulted in gluten tolerance in numerous animal models.
According to the FDA, the fast track process is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need, making it possible to get new drugs to patients earlier.
In addition to receiving the Fast Track Designation, Cour previously announced, in August, that its Investigational New Drug (IND) Application had been opened with the FDA and that it was able to begin its phase 1 program for TIMP-GLIA. “Now that Cour has also received the Fast Track Designation it is placed in a prime position to advance an innovative new approach for the treatment of Celiac Disease,” said John J. Puisis, CEO of Cour Pharmaceuticals.
The Phase 1 program investigating the safety and tolerability of TIMP-GLIA is currently ongoing 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.
TIMP-GLIA is an investigational product, using Cour’s novel technology which proposes to reprogram the body’s immune system in order to enable patients to develop a tolerance to gluten as a non-threatening substance and could subsequently abrogate or reverse the signs and symptoms of celiac disease without using immune suppressing drugs. By encapsulating a component of wheat in a nanoparticle Cour is proposing to develop a “back door” approach, whereby the gluten may not be recognized by the body’s immune system until immune tolerance can be generated through non-inflammatory antigen presentation.
About the Trial for TIMP-GLIA
The Phase 1 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.