Jump to content
This site uses cookies. Continued use is acceptance of our Terms of Use and Privacy Policy. More Info... ×
  • Welcome to Celiac.com!

    You have found your celiac tribe! Join us and ask questions in our forum, share your story, and connect with others.




  • Celiac.com Sponsor (A1):



    Celiac.com Sponsor (A1-M):


  • Get Celiac.com Updates:
    Support Our Content
    eNewsletter
    Donate
  • Record is Archived

    This article is now archived and is closed to further replies.

    Jefferson Adams
    Jefferson Adams

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

    Reviewed and edited by a celiac disease expert.
    First Celiac Disease Treatment Licensed and Set for Late-Stage Clinical Trials - Image: Larazotide--NIH
    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.

    Celiac.com Sponsor (A12):
    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.

    Source:

    • Open Original Shared Link


    User Feedback

    Recommended Comments

    Guest Heather

    Posted

    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.

    Link to comment
    Share on other sites
    Guest Jacquie

    Posted

    Great news, but does it mean, once you start taking the drug, you'll be able to eat normally again?

    Link to comment
    Share on other sites
    Guest steven

    Posted

    Why would take something to mess with your body. Just don't eat Gluten!

    Link to comment
    Share on other sites
    Guest Amir

    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

    Link to comment
    Share on other sites
    Guest Cindy

    Posted

    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.

    Link to comment
    Share on other sites
    Guest Marie

    Posted

    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.

    Link to comment
    Share on other sites
    Guest Ronda

    Posted

    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.

    Link to comment
    Share on other sites
    Guest Terry

    Posted

    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.

    Link to comment
    Share on other sites
    Guest Janet Warren

    Posted

    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.

    Link to comment
    Share on other sites
    Guest Lisa
    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.

    Link to comment
    Share on other sites
    Guest Lynard Henderson

    Posted

    I really hope this works, can't wait to try it.

    Link to comment
    Share on other sites


    Guest
    This is now closed for further comments

  • Get Celiac.com Updates:
    Support Celiac.com:
    Donate
  • About Me

    Jefferson Adams

    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. His articles, essays, poems, stories and book reviews have appeared in numerous magazines, journals, and websites, including North American Project, Antioch Review, Caliban, Mississippi Review, Slate, and more. He is the author of more than 2,500 articles on celiac disease. His university coursework includes studies in science, scientific methodology, biology, anatomy, physiology, medicine, logic, and advanced research. He previously devised health and medical content for Colgate, Dove, Pfizer, Sharecare, Walgreens, and more. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of numerous books, including "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

    >VIEW ALL ARTICLES BY JEFFERSON ADAMS

     


  • Celiac.com Sponsor (A17):
    Celiac.com Sponsor (A17):





    Celiac.com Sponsors (A17-M):




  • Related Articles

    Jefferson Adams
    How Close Are New Celiac Disease Treatments?
    Celiac.com 04/10/2015 - Of course, a strict gluten free diet is still the only safe and effective treatment for celiac disease. However, new drugs in development, some of which are currently being tested on humans, might allow people with celiac disease to safely eat gluten again, at least in small amounts.
    To be fair, even if all goes smoothly, it will be a few years at least before we see such treatments on the market. Moreover, even though many early results have been encouraging, none have yet entered safety trials, the final step before Food and Drug Administration approval and commercial availability.
    Drugs currently under trial include an enzyme that splits the protein in wheat that triggers adverse reactions, into smaller harmless products, and another which promises...


    Jefferson Adams
    Celiac.com 08/12/2015 - There are numerous pills, enzymes, and other products in development that are all designed to provide moderate protection against accidental gluten exposure to people with celiac disease to gluten-intolerance.
    Can a new pill, which uses egg yolk antibodies to coat gluten, allowing it to pass from the body without harm, find a place on the crowded roster of contenders?
    Driven by a desire to provide relief for people with celiac disease, Hoon Sunwoo, an associate professor of pharmaceutical sciences, has spent the last 10 years working on the proprietary pill.
    If Hoon has his way, people with celiac disease may soon be able to enjoy bread, pasta and other gluten products without suffering headaches, digestion problems and severe intestinal damage that come...


    Jefferson Adams
    An Update on Every Celiac Disease Drug Currently in Development
    Celiac.com 08/21/2015 - Here's every celiac disease treatment currently in development in a single list:
    ALV003, by Alvine Pharmaceuticals, is a combination of two enzymes that break down gluten before it can provoke an immune reaction. The drug is a powder to be dissolved in water and taken before meals.

    ALV003 most recently passed a phase 2 clinical trial, results of which appeared in the June 2014 issue of Gastroenterology. Post-trial biopsies showed that ALV003 prevented intestinal damage in 34 volunteers with celiac disease who ate 2 grams of gluten each day for six weeks and also took the drug. Phase 2b, a 12-week trial, is now underway.
      AN-PEP, by DSM Food Specialties, is another enzyme that degrades gluten. AN-PEP is believed to work best when taken while gluten ...


    Jefferson Adams
    Celiac.com 02/04/2016 - BL-7010, a non-absorbable, orally available co-polymer for the treatment of celiac disease, has received designation as Class IIb medical device in the European Union, according to manufacturer BioLineRx Ltd.
    This designation clears path for BioLine’s BL-7010 program, and allows the company to plan the next steps in the development of a commercial version of BL-7010.
    BL-7010 shows a high affinity for gliadins, the proteins in gluten that trigger celiac disease. BL-710 works by sequestering gliadins, effectively masking them from enzymatic breakdown, and blocks the formation of immunogenic peptides that trigger the adverse immune reactions in people with celiac disease. This results in a significantly reduced immune response triggered by gluten. Together with t...


  • Recent Activity

    1. - sh00148 replied to sh00148's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      21

      Vomiting - celiac or constipation

    2. - Wheatwacked replied to sh00148's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      21

      Vomiting - celiac or constipation

    3. - Scott Adams replied to Jack Common's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      3

      How many grams is there in one slice of wheat bread?

    4. - Jack Common replied to Jack Common's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      3

      How many grams is there in one slice of wheat bread?

    5. - Scott Adams replied to Barcino's topic in Post Diagnosis, Recovery & Treatment of Celiac Disease
      2

      Antibodies went up


  • Celiac.com Sponsor (A19):



  • Member Statistics

    • Total Members
      126,399
    • Most Online (within 30 mins)
      7,748

    amiamoramiaint
    Newest Member
    amiamoramiaint
    Joined

  • Celiac.com Sponsor (A20):


  • Forum Statistics

    • Total Topics
      120.9k
    • Total Posts
      69.4k

  • Celiac.com Sponsor (A22):





  • Celiac.com Sponsor (A21):



  • Popular Now

    • disneyfamilyfive
      4
    • Jtestani
  • Popular Articles

    • Scott Adams
    • Scott Adams
    • Scott Adams
    • Scott Adams
    • Scott Adams
  • Upcoming Events

×
×
  • Create New...