Many companies are getting into the race for a cure for Celiac disease. Today, I’m going to talk about Cour Pharmaceuticals Phase 1 trial of TIMP-GLIA
Cour Pharmaceuticals has a drug currently in Phase 1 trials of a drug called TIMP-GLIA. It consists of a proprietary particle surface – on their website it looks like a ball – with a “proprietary core programmed with specific antigen to induce tolerance”. They say that “the body is reprogrammed to recognize gluten as a non-threatening substance and subsequently abrogates/reverses the signs and symptoms of Celiac disease.” Sounds fancy, right?
So, I went to look at the ClinicalTrials.gov web site to learn more about the Phase 1 trial and how it was going. So, it is in an “Active not recruiting” phase, which means they have filled the 22 slots for the participants.
This study consists of a Part A and Part B. In Part A, they are giving the medicine via IV infusion to 2 or 3 people at a certain dose level then watching the participants in the hospital for 2 days. They do a bunch of tests and make sure the person doesn’t die. If that dosage level is safe, then the next group, they give the medicine again via IV infusion at a higher dose. They do this for 7 different dosing levels. So, if you got the lower dose, your job is complete. You don’t get the higher dose. It is like they are trying to find the right dosing level.
Then in Part B, three people will get two IV infusions of the drug 7 days apart. They will have to stay in the hospital for 48 hours after their IV infusion and have a bunch of blood work taken to ensure all is ok.
Now, Phase 1 trials are pretty scary to me. In Phase 1 trials, they are trying to make certain that this drug doesn’t do damage and kill people. But without these pioneers, we would never get to Phase 2 trials. Also, while people have to stay in the hospital after their IV infusion, it may not work that way in subsequent trials.. Once they confirm it is safe, then they might let you do the IV infusion on an outpatient basis. I don’t know and they don’t say – that is just a best guess.
This drug is in its early phases and is interesting, too. I’m not sure when they plan to release results, so we will have to be patient. Attempting to modify the immune system to ignore the gluten is getting at the root cause of the problem. Not masking symptoms, but actually curing the disease — I think that is where we all want to be.
Cour Pharmaceuticals http://www.courpharma.com
Link to ClinicalTrials.gov where I learned about the Cour Pharmaceuticals trial. http://https://clinicaltrials.gov/ct2/show/NCT03486990?term=NCT03486990&rank=1