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!