Many drugs for celiac disease are in the pipeline but two are in late-phase clinical trials – Larazotide acetate and latiglutenase. And another that has been getting a lot of buzz lately – AN-PEP or GliadinX.
Celiac disease does damage to the small intestine. The small intestine are made up of hills and valleys. The hills are the villi. The valleys are the crypts. Villi are small finger-like projections that absorb food. When celiac disease is detected, the junctions between those villi are increased. The junctions are called crypts. The technical term for increased space between crypts is called crypt hyperplasia.
Larazotide Acetate is a drug that tightens those junctions. Earlier studies with larazotide acetate demonstrated a significant reduction in symptoms in “real-life” scenarios. “Real-life” scenarios mean that study participants were already on a completely gluten-free diet. There was no gluten challenge in this study.
The estimated completion date for this study is December 2021. Results and potentially FDA approval will follow.
Latiglutenase works in a completely different way than Larazotide Acetate. It is a gluten degrading enzyme. Its phase 2 study was completed in January 2021.
Remember, this drug has some controversy. Earlier test results dThe drug only works in a subset of the celiac population. It only works in those that still have positive celiac blood tests after being on a gluten-free diet for longer than 6 months. Symptoms are not resolved in those with negative celiac blood tests.
However, there is more news. In this article from BeyondCeliac, they say that the phase 2b results are out. Typically I like to read the source material before quoting results. I cannot find the results. I cannot find a link in the BeyondCeliac article to the source.
So, I’m going to provide you a link to the article and the most interesting quote. BeyondCeliac is a trusted source for information, so I believe this information to be true.
Here is the article link and below is the quote.
“Study subjects experienced 60-88% less small intestine damage and 53-99% less symptoms when treated with latiglutenase versus placebo during the 6-week treatment period. Additionally, subjects experienced a 95% reduction of absorbed gluten immunogenic peptides (GIPs) as measured in their urine. ImmunogenX is moving forward with Phase 3 trials.”
Finally, about ImmunogenX, I love their CypCel technology. I LOVE that there may an end-to-endoscopy to monitor intestinal health.
AN-PEP or GliadinX
When I first started this blog, someone asked me about AN-PEP. It is an over-the-counter gluten degrading enzyme. I said it has not been studied or proven to prevent damage. As of April 9, 2021, a double-blind placebo-controlled study has been registered with ClinicalTrials.gov to test AN-PEP. Researchers will not perform blood tests. They will evaluate the effectiveness of their drug based on GIP in urine. GIP is a gluten immunogenic peptide. In other words, they will study how much gluten is excreted in the urine.
The study is expected to be completed in late 2022. I look forward to the results.