Celiac family….It is time for a complete review of the celiac drug pipeline. Over the next few days I will be reviewing everything that is out there. We will talk about the mechanism of action and where it is in the clinical trial pipeline.
Let’s start with one of the big ones – Latiglutenase.
Latiglutenase is a drug that breaks down gluten in the stomach before it has the ability to do harm. The most recent Phase 2 double-blind placebo controlled study showed the drug protected the small intestine from damage. More specifically 50 patients, half on drug and half on placebo, were given the “drug” and 2g of gluten with their daily meal. Patients on placebo experienced damage to the small intestine and symptoms similar to those prior to celiac diagnosis. Patients on drug did not have the same issue.
There are a couple of oddities with this study. First, only seropositive (TTG IGA+) were allowed in the study. In the past, Latiglutease has not proven effective in those that are seronegative (TTG IGA-) at initiation of the trial. In other words, if celiac is “well controlled” then this drug doesn’t appear to help.
Second, researchers used GIP (Gluten Immunogenic Peptide) urine testing to ensure the patients were all taking their 2g of gluten daily. The placebo group did not have a change in their GIP urine tests. Because of the amount of gluten ingested, it would be expected patients GIP urine tests would be positive. Nor did those on drug, but because this is a gluten degrading enzyme, that result would be expected. Three questions emerge from this phenomenon…Do the GIP urine tests work? Did participants ingest the gluten? Is there some other function in the body preventing the GIP urine test from being effective? Unknown to all three!
This drug still has some kinks to work out and I hope they can figure out what is up!!! They are still recruiting for studies with this drug in Rochester, MN. Tomorrow E40!
That’s interesting that they would only take TTG positive patients. I just read the article on celiac.com about black patients that have a higher TTG negative test result – 80% compared to non-Hispanic white with a 10% negative TTG with positive biopsy (I’m not sure of the exact test and people in the sample). Since I have a background in healthcare, I find it fascinating especially because African Americans tend to have diabetes more than whites and I want to say about 70+% are lactose intolerant. As we know, those usually are issues for those with celiac disease. So the fact that TTG tests wouldn’t be an effective tool for black patients with celiac disease is interesting. Sorry just on my brain this morning after the article. Along with others studies that thyroid testing is not the same for African Americans and they are misdiagnosed with thyroid problems as well. I’m just glad they are finding out more and more so people have more accurate testing to improve their health.
I posted on my facebook page about black people and seronegative TTG celiac yesterday. I think that is why celiac is most commonly thought of as a “white person disease”. Maybe it just is being misdiagnosed a lot more in black people, especially with the confirmation bias of the TTG IGA in play. I think without a complete celiac panel, all 6 tests, it is impossible for blood testing to catch the right people to perform endoscopies. A borderline TTG IGA or TTG IGG and a positive EMA 100% need an endoscopy.