INN-202 – Part 2

I’m feeling ok. I might have over done it on the exercise in the last three days. 11k+ steps for three days in a row and a couple of hard workouts are hard on a gals body and I’ve hit the wall. All other systems are functioning properly!! So, I’m going to sit at this computer and type away!!

I started talking about Larazotide Acetate or INN-202 yesterday. I’m in the Nexvaxx trial and INN-202 is a completely different drug. I want to make that clear.

Last time, we talked about all the good stuff Larazotide Acetate does – like helps with ongoing celiac symptoms and does not increase celiac disease blood markers. Today, we are going to talk about the downsides to the study, like it may not be celiac specific, there were not histology studies done, and lack of study participants over 65.

First, lets talk about how the study results indicate that INN-202 may not be celiac specific. In the study, celiac blood panel markers were looked at before and after the drug was administered. There was no increase or decrease in celiac blood panel markers during the study. The caveat is that the drug did prevent an increase of ant-tTG markers during the gluten challenge. The study authors are saying this may suggest the drug works specifically on celiac disease. They also acknowledge that Larazotide Acetate may work for IBS just as well as celiac. They just don’t know. Many celiac sufferers have IBS or IBD in conjunction with their celiac. Not bad, this just may not be a complete cure for celiac.

Next, there were no histology studies – in this case, studies of biopsy tissue to determine damage to villi – in this study. Their argument is that persistent villious atrophy, the hallmark of celiac disease, does not indicate an increase in mortality over the long term. They cited two studies, one from 2013 and one from 2010 that both agree with this argument. Now, in reading this, I’m angry. If persistent villous atrophy doesn’t matter in long term mortality, why on earth am I eating a gluten free diet? Further digging led me to find that there are other studies that contract these including a recent study from Sweden (see links below). Also, they say that there are no studies indicating the gluten challenge directly leads to villous atrophy and in what time frame.

Really, I think these guys are trying to make the argument that they didn’t need to add histology as part of their study because it doesn’t matter anyway and they don’t know when or how gluten challenge would affect villious architecture. In my mind, I disagree. Their final sentence on this says it all, “histology may not be an appropriate primary end point for clinical trials designed to improve symptoms in patients with CeD on the GFD.”

Finally, the study talks about the lack of participants over 65. I think that is going to be an ongoing issue.

In summary, I think this is a drug that will prevent symptoms. I want a cure. I want to stop worrying all the time about the damage I’m doing that may or may not shorten my lifespan.

Link to the Larazotide Acetate phase 2 clinical trial results – https://www.gastrojournal.org/article/S0016-5085(15)00199-7/fulltext

Information about the positive effects of a gluten free diet including a variety of studies. – https://www.verywellhealth.com/can-celiac-disease-cause-early-death-562338