TIMP-GLIA is a drug that has been around for a while. It got fast-track designation from the FDA in January 2018. It is currently in Phase 2 clinical trials. We are going to talk about that trial for a minute here today.
TIMP-GLIA is currently wrapping up initial Phase 2 trials. Their trial is Active, but not recruiting – which means they have all the participants they need for the trial. Fifty-one participants were in the trial. The estimated wrap up date for the trial is July 2019, so they are at the end of the trial. The trial started in January 2019, so this is a short one.
The way this drug works is that it wraps the gluten protein in a nano-particle so the immune system does not recognize gluten as a danger. According to a press release by Cour, the drug’s manufacturer, in August 2017 the drug works like this, “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.”
I didn’t know what the spleen does, so I looked it up. The spleen is the largest organ in the lymphatic system or what the rest of us call our immune system. It seems the spleen is the filter for all blood and helps pick out bacteria, old red blood cells, and plays a role in systemic immunity. Many people with Celiac have a low functioning spleen. It also plays a role in inflammatory and degenerative diseases.
Back to our study, the study has 2 biopsies and a gluten challenge. The drug is administered intravenously on day 1 and day 8 of the trial. The primary outcome they are evaluating is IFN-γ spot forming units, which help calculate the T-Cell immune response to gluten. The IFN-γ spot forming units are what create the CD4+ T Cells that react in Celiac disease. CD4+ T-Cells are the cells in the immune system that have gone awry with Celiac disease mistakenly attacking the small intestine. Also, the IFN-γ spot forming units are indistinguishable between Celiac patients and non-Celiac patients until a gluten challenge is initiated.
I might have gone too far on that. Anyway, in the study, they are measuring the immune response to gluten challenge after the drug has been administered.
Anyway, they are wrapping up this study and we should be on the lookout for the results soon. I also like that they are testing both blood tests and biopsy results to ensure the drug really works and just doesn’t mask symptoms.
Just because Nexvax might not have worked the way they thought, we have to remain hopeful that something else will be out shortly.