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Cour Pharma receives US FDA fast track status for TIMP-GLIA to treat Celiac disease

Saturday, January 13, 2018, 17:00 Hrs  [IST]

Cour Pharmaceuticals has announced that the US 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.

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.

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.


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