Anybody Heard Of Zonulin?

[Guest AutumnE]

I read how its a medication that you can take it before your going to eat gluten and it will prevent damage for celiacs. At least its the hope that it will and its suppose to be in phase 2 this summer of testing.

Would you try it right away or wait and see the effects long term first?

I think, big if though, wait and stay on the diet because as with other meds I generally dont try them till they have been out for 10 years at least.

[floridanative]

I'm in the wait a good ten years crowd and by that time, I'll be 55 assuming the drug will be out in two years. However, I know others who'll be first in line to take it - my own Mother for instance. So I'll know what her reaction is to it at least. Personally I'd rather just eat healthy and I don't think that includes eating a lot of wheat, for anyone.

[Guest AutumnE]

I feel the same way, wheat isnt really good for anyone, just empty calories and contains natural toxins like beans and potatoes which is why I try and stay away from those also. Although I get in a pinch and need peanut butter once in a while for protein while I'm out.

[Nic]

I wonder if the intention of the manufacturer of Zonulin is for the Celiac to completely reintroduce gluten back into the diet. Or is it more for the little things like cross contamination or eating fries that were cooked in the same oil as breaded chicken. Just curious if anyone knows either way. I also heard that it might be available within this next year.

Nicole

[Guest AutumnE]

On wikipedia it listed it is used before eating gluten so I guess it would most widely used when you were eating out or traveling, family functions that sort of thing but Im not sure.

[chrissy]

we are testing our girls TTg levels on a fairly regular basis and can tell whether or not they get gluten. i think if someone were to test levels before using the med, and then test again within 3 months, they would get a pretty good idea of whether or not the zonulin was working.

[Rikki Tikki]

I don't think I would try it.

[eleep]

I think this is something I could only imagine using as a prophylactic against cross-contamination were I eating out a lot or travelling or something like that.

[debmidge]

From what I read about it, it seems like a good solution to the accidental cross contamination potential. I am not certain if Alba is creating this drug AT-1001 to replace the gluten-free diet or to act as a backup for the CC. I wouldn't dismiss it out of hand - sounds like a plan for backing up in the event of CC.

Acording to Celiac.com's report of 10/05 Alba Theraputics Corporation concluded Phase I Trial. Their phone number is (410) 522-8708. Alba co founder is Dr. Alessio Fasano (U of Maryland).

[Nic]

I forgot to mention that I have a friend who works for a hospital that has been keeping a watch on the Alba AT-1001 study and he told me about a week ago that they are in phase 2. I don't know how accurate that is.

Nicole

[happygirl]

www.albatherapeutics.com

It was founded by Dr. Fassano, one of the leading Celiac researchers, and Dr. Blake Patterson. There are numerous posts on the forum about zonulin, as well as article blurbs on celiac.com. The pill is not zonulin---zonulin is what they believe is "over expressed," which allows gluten to penetrate barrier cells that should have gluten pass. My understanding is that the drug is to decrease the overexpression of sonulin, thus closing the "gates." The first phase was extremely successful. I had the pleasure of hearing Dr. Patterson speak to the Richmond GIG group right at the end of phase 1....it was an inspiring speech. It was a blind study, meaning the participants did not know if they had taken a placebo or the drug. Minimal to no side effects were reported.

https://www.celiac.com/st_sresults.html?p_keyword=zonulin

[chrissy]

what was involved in phase 1 of the testing? is phase 2 human trials? if i remember right, this drug will only work for celiacs, not those with wheat allergies---is this right?

[happygirl]

the drug is only being tested on biopsy confirmed celiacs, so my thought would be that it is only for celiacs. who knows where this drug will lead though. the premise behind zonulin has research supporting its relation to type 1 diabetes---their hope is that it will help other autoimmune disorders by "closing" the leaky gut, essentially.

zonulin was initially identified by dr. fassano in his medical research. they formed the drug company, and then safety trials were performed, and phase 1 was a small human study. Maybe 24 people? (I don't remember the exact number. but I think 2/3 were given the drug, 1/3 the placebo.

this is on their webpage---hope this helps.

November 04, 2005

Alba Therapeutics and the University of Maryland Report the Role of Zonulin and Intestinal Permeability in Celiac Disease

BALTIMORE, M.D.; November 4, 2005 – Today a team of scientists at Alba Therapeutics Corporation (“Alba”) and the University of Maryland School of Medicine reported a direct link between gluten-induced intestinal permeability and zonulin in tissues from patients with celiac disease (“celiac disease”). The investigators were able to successfully prevent gluten-induced intestinal tissue leak with the administration of the zonulin antagonist FZI/0 (“AT-1001”). AT-1001 is an orally administered peptide currently under development for the treatment of celiac disease.

Published in the November issue of the Scandinavian Journal of Gastroenterology, these results describe the role that ‘leaky gut’ plays in celiac disease and the role that zonulin plays in establishing the leak. ”These results are another milestone towards understanding the role of zonulin in celiac disease,”, says Alessio Fasano, M.D., lead author of the paper, professor of pediatrics, medicine and physiology at the University of Maryland School of Medicine and director of its Center for Celiac Research.

"These results reinforce our conviction that AT-1001 has great therapeutic potential and we look forward to confirming these observations in celiac patients soon," stated Alba CEO Dr. Blake M. Paterson.

Alba Therapeutics Announces Positive Phase Ib Clinical Trial Results

BALTIMORE

Alba Therapeutics Corporation announced today successful completion of Phase Ib proof-of-concept studies for its lead compound, AT1001. In a 21-patient cohort of celiac disease sufferers, the oral administration of AT1001 versus placebo control induced a significantly positive result in the trial's primary target endpoint.

"We anticipated a strong signal, however, the magnitude of the response surpassed our expectations," stated Blake Paterson, M.D., President and CEO of Alba. "We are particularly excited, as to the best of our knowledge this is the first demonstration of a desired and systemic immunological effect resulting from a physiological event at a mucosal surface."

AT1001 is an antagonist to the zonulin system -- a signaling pathway discovered by Alessio Fasano, M.D., Professor of Pediatrics, Medicine and Physiology at the University of Maryland School of Medicine, and the basis of Alba's extensive intellectual property portfolio.

About Zonulin

Zonulin is a signaling protein that transiently and reversibly opens the tight junctions ("tj") between the cells of epithelial and endothelial tissues such as the intestinal mucosa, blood brain barrier and pulmonary epithelia. Zonulin appears to be involved in many diseases in which leakage occurs via paracellular transport across epithelial and endothelial tight junctions (tj), and thus may play an important potential role in the treatment of autoimmune diseases.

April 03, 2006

Alba Therapeutics Corporation Completes Phase I for AT-1001

BALTIMORE

Alba Therapeutics Corporation today announced the successful completion of multidose safety studies in normal volunteers, concluding Phase I trials for its lead compound, oral AT-1001. Combined with Alba's previous single dose study and Phase Ib demonstration of intestinal permeability decrease in gluten-challenged celiac disease patients, this safety data brings the company closer to its goal of delivering an autoimmune treatment based upon modulation of mucosal barrier function. "We look forward to filing a diabetes IND and to entering Phase II trials for celiac disease as early as this summer," stated Dr. Blake Paterson, CEO of Alba, "and continue to develop the breadth of our core technology platform for multiple applications."

[elye]

Wow, very informative...thanks for all that! I've just been at another post where zonulin was mentioned, and I'll bring up my point here, too. The news about a commercial drug on the horizon to treat the symptoms of celiac is INCREDIBLE news for us, not only because we will have the option of relieving the symptoms, but because celiac will suddenly become BIG NEWS! Once a major pharmaceutical company develops an expensive treatment for a condition, there will be lots of media chat about it. And this is what we've all been yelling for--from Oprah to commercial song-writing, we've been trying to come up with a way to get the word out about our ignored, misdiagnosed disease! EXCELLENT!

[happygirl]

Emily-

If by chance you ever have the opportunity to hear either of these men give a presentation, I know you would enjoy it. I was so inspired...not just for the outlook on Celiac, but the underlying research that could potentially be a MAJOR breakthrough in the way doctors learn about auto-immune disorders. I went with my mother-in-law and grandmother-in-law (I luckily have a wonderfully supportive family) and we all were so impressed. I am in general, disgruntled with the medical community because of my treatment before being finally dx with Celiac....BUT, this keeps my faith that there are smart, innovative doctors out there that are truly working to make the world a better place.

Sigh. Off my soapbox now.

[jcc]

I read how its a medication that you can take it before your going to eat gluten and it will prevent damage for celiacs. At least its the hope that it will and its suppose to be in phase 2 this summer of testing.

Would you try it right away or wait and see the effects long term first?

I think, big if though, wait and stay on the diet because as with other meds I generally dont try them till they have been out for 10 years at least.

Here are a few other studies/articles about Open Original Shared Link:

I am curiously waiting and watching the results of the zonulin trial. I have heard that one prominent celiac expert says it only addresses part of the problem~ but watching this all play out is really interesting. It has implications far beyond celiac disease~

Cara

[Nancym]

It has implications far beyond celiac disease~

Definitely! Like how to get medicines to the brain. But boy, I'd hate to be in THAT clinical trial.

[hineini]

I wish I could find the link for the other drug that's in development stages, which is an enzyme supplement that breaks down the element of gluten that we're allergic to... It is further behind in development (it still can't completely break down gluten in the lab, but they're getting closer).

Anyway, my attitude is that even with a med such as this I don't think I'd introduce gluten back into my diet... However, I would DEFINITELY take a medication like this before eating out at restaurants or eating products that i haven't verified the sources of... In other words, as a prophylactic against cross-contamination (in the words of a previous poster). For instance, I might be able to eat French Fries without worrying whether they were fried in the same oil as fried chicken... Or I could eat a taco with a corn tortilla and not worry if a few specks of wheat flour are on it from sharing a griddle with wheat tortillas.

That would be a terrific thing, in my book. HOwever, I don't like the idea of a drug making people think that wheat is a healthy food to eat. Because the more research I do, the more convinced I become that wheat is certainly not intended to be a major component of the human diet (at least not as major as it is in the standard Western diet!)

[tomsmom]

I don't think I could over come the temptation to use the medicine and eat like normal. I'm seriously chomping at the bit to revisit my favorite beer and pizza pub. I've been a good girl the last 7 years and totally avoided anything more than a little soy sauce now and then but I've never really lost my taste for all things glutenous.

I'm going to eat it all . . . Twinkies, KitKats, Cowstails, Rootbeer, Cookies and Cream Ice Cream, Oreo's, Carrot Cake, Wonderbread, fried fish sandwiches, Veggie burgers, Arbys fries, zuchini bread, croutons, gingerbread men, Rits crackers, biscuits and applebutter, not to mention eating out at restaurants, parties, festivals and friends homes. I'm going to put on a little weight I think.

Ellie

[elonwy]

Since I'm in the midst of recovering from an In and Out glutening, after having them go back remake my burger while I watched, I would give pretty much anything for a prophylactic drug for cross contamination issues. The phase II trials are going well, and the drug is being fast-tracked by the FDA. I do not see this as "Oh I can have gluten" but as a way to deal with CC while eating out.

Bring it on.

So far so good: "AT-1001 is well tolerated and appears to reduce intestinal barrier dysfunction, proinflammatory cytokine production, and gastrointestinal symptoms in coeliacs after gluten exposure."

They are looking for trial subjects for the IIb phase (nothing near me, sadly)

Open Original Shared Link

[happygirl]

I believe that you must have a positive biopsy diagnosis for inclusion in the study....at least that was the case earlier on.

[elonwy]

The study guidelines for this phase an non-specific as to how you've been diagnosed. I believe as long as its "official" you're good. They were much more specific in phase one.

[Generic]

I will volunteer for the testing phase they are having it in my area, but aren't recruiting yet. I would never take it other than as CC protection. I would put myself through the pain and suffering if they could come up with something that could prevent damage.

It would be for my stubborn dad and sister who refuse to go gluten free even thou it will probably kill them. My grandma (deceased now) had stomach cancer at one point. They cut part of her liver, intestines and I think possibly part of her pancreas out.

[cyberprof]

Since I'm in the midst of recovering from an In and Out glutening, after having them go back remake my burger while I watched, I would give pretty much anything for a prophylactic drug for cross contamination issues. The phase II trials are going well, and the drug is being fast-tracked by the FDA. I do not see this as "Oh I can have gluten" but as a way to deal with CC while eating out.

Bring it on.

So far so good: "AT-1001 is well tolerated and appears to reduce intestinal barrier dysfunction, proinflammatory cytokine production, and gastrointestinal symptoms in coeliacs after gluten exposure."

They are looking for trial subjects for the IIb phase (nothing near me, sadly)

Open Original Shared Link

I agree, I'd use it for CC problems when eating out and/or traveling. Not for everyday use, certainly, but for special occasions.

~Laura

[debmidge]

Open Original Shared Link

update as of 9/07 and it's now about 6 weeks after study began --- so this part is probably over by now and they are analyzing the data. Can't wait until their next press release.