I read that last week you shut down the Nexvax trial due to the interim results not showing a statistical difference between placebo and drug.
I want to say that from a personal perspective I disagree. See, I was the one that had an allergic reaction 4 shots from the end of the trial and had to be removed for my own safety. Though disappointing, I completely agree with the decision. We don’t know if I was having an allergic reaction to the drug or the amoxicillin I was taking at the time, but I did need to stop.
I did however participate in two of the food challenges. The first food challenge was smooth sailing – no reaction. The second food challenge was a bit of a disaster, sort of. Immediately I reacted to the food challenge by vomiting and feeling lousy. Unlike the gluten challenge when we started this trial, I was better the next day (save an allergic reaction). In the initial gluten challenge, I was miserable for a week before recovering. In the second food challenge, I bounced back after a day.
I want to say that during the updosing phase of the trial, there were days when the doses got larger that I didn’t feel well. It would take a day or two to get over the hump and adjust to the new levels of medication. I think that this may be the case with the food challenges in the study. I think that if people were to do another food challenge a little later in the trial they would not have reacted so violently.
Or maybe the food challenges had too much gluten. You were testing Nexvax as protection against cross contamination and the gluten in two slices of bread is significantly more than cross contamination. I think a lower level of gluten in the food challenges may yield better results.
I do want to say that I was very impressed with your study design. I love the idea that you were doing endoscopic biopsies to prove that no new damage was occurring in the small intestine. I love all the blood tests that you too and that you were constantly monitoring the TTG IGA to make sure it wasn’t going up as a result of this trial.
From the people I’ve talked to about this trial, things were going well. Yes, they may have gotten sick at a food trial, but as with me, they recovered more quickly and were about to withstand the gluten storm more easily. In the real world, the people I talked with in the trial were feeling better, having more energy, and excited about the prospect of a cure for this disease.
In summary, I hope that you look at the data carefully. I hope that the drug worked in some capacity. I hope that you captured lots of good data and are willing to relaunch this study with maybe less lofty goals. I hope to see this drug in trials again sooner rather than later.