At-1001 Clinical Trial

[Swingin' Celiac]

I'm thinking about participating in a clinical trial for the new experimental celiac disease drug by Alba Therapeutics AT-1001 (a.k.a larazotide acetate). From what I've read, it appears that the drug is not supposed to be a substitute for a gluten-free diet, but would be useful for protecting us from a small amount of gluten in the case of cross-contamination.

Anyway, the drug is in Phase IIb of clinical trials, so it has already been tested on a few different groups of people. So far, there haven't been any serious side effects or "adverse events" reported. However, the number of people in previous trials was not particularly great maybe a few hundred or so, so they can't guarantee anything.

I'm not exactly sure what to do. I'm all for the progress of science, especially in the field of celiac disease research and it would be cool to be a hero for the cause. However, I don't think I should just jump into this blindly. When I first heard about the drug, I was under the impression that I'd be able to eat bread again and was like "sign me up", but that doesn't seem to be the case. Although I wouldn't have to be quite so paranoid about CC which would be nice. In the test, I'd still be required to maintain my gluten-free diet, I'd take the pill three times a day, and I'd have to get a total of two upper endoscopies/biopsies (one at the beginning and end of the study). Personally, I think that the greatest risk would be from the endoscopies, but at least in that case you know the risks going in. Anyway, do you think it would be worth the risk? Any insights into clinical trials in general or AT-1001 in particular?

One other confusing thing. They said that they would do a blood test to make sure that I was adhering to a gluten-free diet, but that they would also do an endoscopic biopsy to make sure I had "Active Celiac Disease." Now I was under the impression that one had to be eating gluten in order for celiac disease to be diagnosed via biopsy, but they told me to stay on a gluten-free diet. Am I missing something? I thought healed gluten-free celiac disease intestines were virtually indistinguishable from healthy non-celiac disease intestines. Anyway, just me being curious.

[gfp]

I'm thinking about participating in a clinical trial for the new experimental celiac disease drug by Alba Therapeutics AT-1001 (a.k.a larazotide acetate). From what I've read, it appears that the drug is not supposed to be a substitute for a gluten-free diet, but would be useful for protecting us from a small amount of gluten in the case of cross-contamination.

Anyway, the drug is in Phase IIb of clinical trials, so it has already been tested on a few different groups of people. So far, there haven't been any serious side effects or "adverse events" reported. However, the number of people in previous trials was not particularly great maybe a few hundred or so, so they can't guarantee anything.

I'm not exactly sure what to do. I'm all for the progress of science, especially in the field of celiac disease research and it would be cool to be a hero for the cause. However, I don't think I should just jump into this blindly. When I first heard about the drug, I was under the impression that I'd be able to eat bread again and was like "sign me up", but that doesn't seem to be the case. Although I wouldn't have to be quite so paranoid about CC which would be nice. In the test, I'd still be required to maintain my gluten-free diet, I'd take the pill three times a day, and I'd have to get a total of two upper endoscopies/biopsies (one at the beginning and end of the study). Personally, I think that the greatest risk would be from the endoscopies, but at least in that case you know the risks going in. Anyway, do you think it would be worth the risk? Any insights into clinical trials in general or AT-1001 in particular?

One other confusing thing. They said that they would do a blood test to make sure that I was adhering to a gluten-free diet, but that they would also do an endoscopic biopsy to make sure I had "Active Celiac Disease." Now I was under the impression that one had to be eating gluten in order for celiac disease to be diagnosed via biopsy, but they told me to stay on a gluten-free diet. Am I missing something? I thought healed gluten-free celiac disease intestines were virtually indistinguishable from healthy non-celiac disease intestines. Anyway, just me being curious.

Hmmm, not sure a clinical trial is actually science !!!

They seem (reading what you said) to actually only take people who are gluten lite .. not 100% gluten-free.

If they were actually interested in 'science' as opposed to ONLY the bottom line they would be doing a lot research on 100% gluten-free people...

However if they did that they would have to come up with a baseline for the blood tests for someone who is actually gluten-free not gluten-lite and I suspect that they suspect this will mess up their results.

I say they suspect since they probably haven't tested ... which answers your question really about clinical trials...

The trials are done to prove a drug works ... not for science or the benefit of the population etc. but for the bottom line of the company.

The worlds most successful drug marketing campaign is said to be (according to Harvaard Business School) Ranitidine (Zantac) ...

Glaxo-Welcome spent millions developing the ideal drug (didn't cure ANYTHING but had a life long dependency) ...

Most of the way through their research two austrailian Dr's published a paper on h. pylori and how most ulcers can be cured by 25c worth of antibiotics. Glaxo-welcome then spent more millions paying off Dr's and bullying scientific journals, hiring 'PI's' to intimidate the Dr's and trying to dig up dirt...

Eventually .... (after an estimated several hundred thousand deaths from ulcers) the australian government actually interceded... and forced an open press in Australia ... this snowballed until their were investigations etc. in the scientific publishers (blackwell, elsevier etc.) ... and the publishers were found to be biassed towards their advertisers (like it needs an investigation)....