ImmugenX is a company developing the drug Latiglutenase (ALV003) and here’s what I found.
Latiglutenase is a drug that is designed to “protect the small intestine from damage caused by gluten exposure.” They have done Phase 1, Phase 2a, and Phase 2b studies. Here’s the interesting part – there are two sets of results from the Phase 2 studies.
The first set of results in November 2016 said that “latiglutenase did not improve histologic and symptom scores when compared with placebo.” Ok. It doesn’t work. In September 2017, say that symptoms were reduced when celiac patients took Latiglutenase with meals. A year later with no additional research, the results changed? So, how can that be? The results did improve symptoms or the results did not improve symptoms – it can only be one of the two.
The September 2017 article describes the difference, “The primary endpoint for histologic improvement was not met, presumably due to a trial effect. In this post hoc analysis, we investigated the efficacy of latiglutenase for reducing symptoms in subgroups of the study participants based on their seropositivity.” So, now they are saying, we didn’t heal or protect intenstines. Ok. In further digging, of the 500 patients tested 398 had at least one positive celiac positive blood test – these are people that are supposed to be on a GF diet! Anyway, in the people with positive blood tests had significant improvements in bloating, constipation, and abdominal pain but no improvement in intestinal damage.
At this point, I think they don’t know what they’ve found and I think they need another study. Luckily for them, they have another study starting soon with 80 patients at the Mayo Clinic and it will include a gluten challenge. Hopefully, we will get a fuller picture of what this drug can do. The study was supposed to start in January 2019, but should start soon. Hopefully, they can clarify what is going on with Latiglutenase. They might have something, they just don’t know what it is yet or how it will affect celiac patients.
I’m not a doctor and all of this information is publicly available. I’m trying to let you guys know what I’m finding.
Article saying there was no difference: https://www.gastrojournal.org/article/S0016-5085(16)35346-X/abstract?referrer=http%3A%2F%2Fwww.healio.com%2Fgastroenterology%2Fmalabsorption%2Fnews%2Fonline%2F%257B530cd801-4fa7-4b1f-91b0-c4ecf36280ac%257D%2Flatiglutenase-placebo-similarly-improve-histology-symptoms-in-celiac-disease
Article saying there was a difference: https://www.ncbi.nlm.nih.gov/pubmed/28755266