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  • Jefferson Adams
    Jefferson Adams

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

    Reviewed and edited by a celiac disease expert.

    Caption: Image: Larazotide--NIH

    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.

    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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    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 gluten-free 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.

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    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

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    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.

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    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.

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    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.

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    Sounds promising. I don't mind being on a gluten-free 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.

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    Sounds promising. I don't mind being on a gluten-free 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.

    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.

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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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