ImmunogenX has started recruiting for their trial of Latiglutenase and CypCel.
ImmunogenX has a medicine called Latiglutenase . The medicine according to ImmunogenX’s web site is, “a mixture of recombinant proteases that degrade gluten proteins in the stomach rendering them physiologically inactive.” All good there. They say further that Latiglutenase has, “demonstrated protection of intestinal mucosal injury and symptomatic improvement in CD patients.” Ok, but they didn’t prove it.
What the most recent study showed was that participants with positive celiac blood panels symptoms were reduced, which is good. Except, with a positive celiac blood panel it demonstrates that the person wasn’t following a gluten free diet. So, they improved symptoms on celiac patients while they were still consuming gluten. Good job.
So to solve this problem, the study is designed for people to take the Latiglutenase with gluten at their evening meal, therefore ensuring a positive result to the study. How do I know this? Part of the study criteria is this according to clinicaltrials.gov, “Agree to maintain dosing of approved prescribed and OTC medications; Willing to take study treatment with evening meal during any single day; Willing to take gluten foodstuff with evening meal during any single day; Willing to maintain GFD for entire study duration; Willing to agree to minimal ingestion outside of three main daily meals.”
I’m no scientist and I certainly don’t have intimate knowledge of how these studies should be designed. But this one doesn’t seem right. They have designed the study to take a gluten food stuff potentially (I don’t know this for sure but am guessing here) on the same day they give the trial medicine that they have already proven helps with symptoms. Now, this is great for accidental exposure or going to a friend’s house for dinner. But is it a cure? Is this good enough?
Furthermore, the previous phase 2 clinical trials for Latiglutenase did not involve endoscopic biopsies. So, I’m not sure how they know it offered protection from mucosal injury. But, I’ll just roll with that one.
I’ve gotta make a hard transition to what I think is the most interesting part of this trial is CypCel. This is a test for mucosal damage. The test involves taking a statin that in uniquely broken down in the small intestine, specifically a particular enzyme that only exists on villi. They can measure how much damage is done to your villi by measuring how much of the drug is excreted. So, if your villi are healthy, you will absorb more of the drug than if they are flattened. I’m not sure if this will be a diagnostic tool or a monitoring tool, but I think it is really smart and really cool.
Back to my ranting about a cure for celiac! I’m all for a cure for this disease, but that’s what I want – A Cure. A way to make my life better, and not just mask the symptoms. Maybe I’m being too hard on these guys and maybe they have it. Maybe they found the cure. I don’t know. Nexvax isn’t proven either, so I could be supporting the wrong cause. What I do know is that all of this testing is in its infancy and I’m just darn glad to see it! I’m glad that drug companies are starting to take a look at this disease and understand that a gluten free diet is nearly impossible these days.
Many of us suffer on a day to day basis with an unwieldy rash, large numbers of trips to the bathroom, or just body aches that won’t go away. We shy away from social events because of awkward conversations about why we can’t eat whatever delicious gluteny food is put in front of us. Or just being able to not worry so much about each and every bite of food we use to nourish our bodies. So anyway, I’m super stoked about the testing and hope that we find a solution sooner rather than later.
Also, if you are in the Rochester, MN area, please consider joining the trial. Here is the link to clinical trial information on the Latiglutenase .
Information from Beyond Celiac regarding the trial and the recalculation of the Phase 2 data.
ImmunogenX’s web site and press release about CypCel