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First Celiac Disease Treatment Licensed and Set for Late-Stage Clinical Trials

Celiac.com 04/04/2016 - Any one eager to try the first approved treatment for celiac disease might not have to wait much longer.

Image: Larazotide--NIHAlba Therapeutics has announced that their celiac treatment, larazotide acetate, will enter the first Phase 3 clinical trials ever conducted in a celiac disease drug later this year.

Lorazotide acetate works by improving regulation of tight junctions in the bowel. In healthy people, these junctions remain closed except to shed dead cells, but in patients with celiac disease, gluten keeps tight junctions open, triggering an inflammatory reaction that eventually destroys the intestinal villi, tiny, finger-like projections in the small intestine that are essential for nutrient absorption.

Early research suggests larazotide acetate helps to keep the tight junctions closed when it's taken before a meal, thus stopping, or reducing the reaction and the resulting inflammation.

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Larazotide acetate recently completed during phase 2b clinical trials for efficacy, safety and tolerability in 342 patients with celiac disease. Those trials showed larazotide acetate to be safe and effective in a "real world setting" for celiac patients, according to Alba's website.

The treatment is now headed to Phase 3 trials in "late 2016", and has received "fast track" designation from the Food and Drug Administration.

Alba has announced that Innovate Biopharmaceuticals Inc. has licensed all of Alba Therapeutics' assets related to larazotide acetate, and that larazotide acetate has been renamed INN-202.

If approved on schedule, INN-202 will become the first prescription medicine for treating celiac disease.

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11 Responses:

 
Heather
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said this on
11 Apr 2016 5:00:34 AM PDT
Having done some reading on this, it's important to note that this drug is not some miracle cure. It is a treatment to be used WITH a GF diet, on the assumption that even the best attempts to protect one's self from ingesting gluten are not always entirely successful. It's not a pop-a-pill then return to eating gluten...so let's hope the marketing of this drug doesn't oversell its abilities.

 
Jacquie
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said this on
11 Apr 2016 8:57:19 AM PDT
Great news, but does it mean, once you start taking the drug, you'll be able to eat normally again?

 
steven
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said this on
11 Apr 2016 12:25:35 PM PDT
Why would take something to mess with your body. Just don't eat Gluten!

 
Amir
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said this on
11 Apr 2016 7:25:27 PM PDT
What a good news for all celiac people. I hope they finish the phase 3 phase soon this year. Furthermore, I hope there is not any side effect in the long run. Thanks Aba

 
Cindy
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said this on
11 Apr 2016 9:29:36 PM PDT
I was in this clinical trial in Scottsdale Arizona many years ago. It was on the "fast track" then and it still isn't available? How can this be? How much money does it take to release a new drug? How much money do the drug companies need to make before the drug is released? I find this whole process unbelievable. It had to have been 2009 when I was in the trial in Az.

 
Marie
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said this on
12 Apr 2016 5:30:31 AM PDT
I do not trust pharmaceuticals; they always mention the positives but they have not mentioned if this did not work for some people with celiac disease. If this did not work for some people, this medication is not good. They also do not talk about side effects or possible long term effects. I remember when Dr. Fasano did his trials with a new medication for celiac disease (and Crohn´s) the medication did not work on some of the subjects.
I think the best medication for celiac would be DNA manipulation which would be a reality in the future;maybe we are not going to be here to witness it.

 
Ronda
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said this on
12 Apr 2016 6:48:31 AM PDT
I have concerns regarding "treatment" of a genetic disorder. A drug could hold down symptoms but what would be the long lasting effect of holding down symptoms? I think we too often think of pharmaceutical treatment as healing when it is not. Gluten free eating is healthy and has no harm. Maybe we will be better off not to run to a pill.

 
Terry
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said this on
12 Apr 2016 7:02:31 AM PDT
Sounds promising. I don't mind being on a GF diet for my celiac most of the time. It would be nice to have something to take for special occasions. Looking forward to hearing more on this.

 
Lisa
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said this on
12 Apr 2016 3:09:05 PM PDT
I agree with you Terry! It would be nice to have something to take for special occasions! Although, not so sure I feel comfortable enough completely going off my gluten free diet.

 
Janet Warren
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said this on
12 Apr 2016 9:52:22 AM PDT
I really hope this works! I'm 47 and was just diagnosed 2 years ago. I really want to go back to living a normal lifestyle.

 
Lynard Henderson
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said this on
29 Aug 2016 6:50:41 PM PDT
I really hope this works, can't wait to try it.




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So just to clarify had not consumed any gluten for about 4 days before testing. I was assured by my allergist that it wouldn't affect the test. But what was alarming was that she retested my food allergies (my most recent reaction was two weeks ago) and every food allergy I have came back negative. I don't understand how that is possible. These food allergies developed when I was 20 and I am almost 24 now.

Thanks! You too! I have learned from this experience to take charge of my own health. It's nice at least that we can try the gluten-free treatment without a firm diagnosis or a doctor confirming the disease. I've also felt some of the gluten withdrawal symptoms, and my stomach pain ebbs and flows, but I'm determined to stick with the gluten-free diet to see what a difference it makes. Gemini, thank you! This was really validating and useful for me to hear. I've felt so confused through this process and just want some answers. If the biopsy results do come back negative, I'm going to follow your advice and do the gluten-free diet with repeat blood testing after a while. If they come back positive, well, then I'll have my answer. I'm supposed to get them back next week.

I have celiac and eosinaphalic esophagitis. I was put on a steroid inhaler recently. I use it like an inhaler but swallow the air instead of breathing it in. You may want to look into EOE and it's relationship to celiac. Just a thought. My swallowing and celiac seem to be related.

You have eat gluten every single day until after testing. And the celiac blood test is supposed to be done as well.

If I was the big guy, there's no way I would have to wait 3 and a half weeks for a test lol. My GI doc never recommended the antibody test. He said doing it with the scope was the only sure way to know. Does anybody know if I should eat a little gluten the day before my test to see if I will get an accurate enough test? Or will it not matter, once the damage is done it's done?