ImmusanT announced that they are terminating the Phase 2 trial of Nexvax 2. Their press release says, “The results from an interim analysis revealed Nexvax2 did not provide statistically meaningful protection from gluten exposure for celiac disease patients when compared with placebo.”
Okay.
I’m not sure exactly what that means. Does that mean that the gluten challenges failed for those receiving the medication? Does that mean that the scores from the daily surveys indicating the presence or absence of symptoms was unchanged? Does that mean biopsies were not changed? This just makes me ask more questions.
In everything ImmusanT put out, they said that this drug would help protect against cross contamination. They were very careful not to talk about this being a cure. (Some of us, me included, thought this might be the silver bullet cure.) But ImmusanT never did. They always talked about this drug being protective against cross-contamination. In designing the study, they have three food challenges – one gluten, one placebo, and either gluten or placebo. The gluten in the challenge was the equivalent of 2 slices of bread. That’s a lot of cross contamination. At that level of testing, that’s a cure in my book. So, was the gluten content of the gluten challenge too high? Could this have made a difference if the gluten levels were lower?
We did have to do a survey every night about the symptoms we experienced. We had to rate symptoms such as headache, fatigue, diarrhea, loose stool, and some others daily and they were sticklers about it. I know my reporting of symptoms went down and I had almost no symptoms toward the end of the trial. I was feeling really, really good at the end of the trial. So maybe others didn’t have that same experience. I don’t know.
Let’s not forget those of us that were a part of the sub-study. Those in the sub-study had endoscopes with biopsy. There was an endoscopy before any injections were made and one was scheduled about two weeks after the final food challenge. Those would be interesting to get my hands on too! We were not provided those results in the test results I received. In the sub-study were they able to see a difference in the biopsy results between those that received Nexvax and those that didn’t?
I will say that even though this abrupt stopping of the trial seems bad there might be something there. I have seen study results come out shortly after a trial is complete and they say that the drug was a dud and didn’t do what they thought. Over time, they look at the data again and might find something they didn’t see before. That is a possibility with this.
ImmusanT is still publishing results from their Phase 1 studies with Nexvax. They just published in the journal Gastroenterology 10 days ago about how Interleukin-2 (IL-2) which is a pro-inflammatory cytonkine rises immediately in the blood of celiac patients upon gluten exposure but does not rise in those without celiac. They think this might be a new way to diagnose celiac disease by testing IL-2 after a gluten challenge. New information from old data or maybe a new diagnostic testing method.
We are all reading the tea leaves here and they will tell us what they want us to know. Over time more and more information will come out about what happened and why they stopped this trial. My hope is that they were just overly ambitious with the gluten challenge. My fear is that Nexvax doesn’t work. From my personal experience though, I think Nexvax works and that is what I hope.
Don’t lose hope, there are 10-15 drugs in various stages of drug development. And as soon as Larazotide Acetate or INN202 starts their Phase 3 trial, I will let everyone know. Again, Larazotide isn’t my favorite in the field, but it might be enough.
Until then, keep eating gluten free and hope that there is something on the way.
Here is a link to the ImmusanT press release.