Jump to content
  • Sign Up
  • Join Our Community!

    Get help in our celiac / gluten-free forum.

  • Jefferson Adams
    Jefferson Adams

    An Update on Every Celiac Disease Drug Currently in Development

    Reviewed and edited by a celiac disease expert.

      Numerous drugs designed to treat celiac disease are currently in development, and more than one of them could be on the market very soon.


    Caption: Image: CC--Robson#

    Celiac.com 08/21/2015 - Here's every celiac disease treatment currently in development in a single list:

    • Image: CC--Robson#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 is still in the stomach.

      Results from a small 2013 study showing AN-PEP to be safe, appeared in the World Journal of Gastroenterology. For the study, 16 people ate 7 grams of gluten every day for two weeks and half of them also ate AN-PEP, and half took a placebo. However, the placebo group did not get sick enough during the course of the study to show that the enzyme had any effect, so further study is under way.
       
    • ActoBiotics by ActoGenX uses Lactococcus lactis as an expression system to locally secrete bio-therapeutics such as cytokines, antibodies, hormones, etc.

      Early pre-clinical work with a genetically altered L. lactis secreting a peptide derived from gliadin demonstrated an in vivo suppression of gluten sensitization.

      Specifically, Huigbregtse et al. engineered L. lactis to secrete a deamidated DQ8 gliadin epitope (LL-eDQ8d) and studied the induction of Ag-specific tolerance in NOD ABo DQ8 transgenic mice [34]. Although apparently not part of the ActoGenX development program, recent work by Galipeau et al. also deserves mention in this context.

      The group treated gluten-sensitive mice with elafin, a serine protease inhibitor, delivered by the L. lactis vector, and found normalization of inflammation, improved permeability, and maintained ZO-1 expression. There is speculation that this is due to reduced deamidation of gliadin peptide.
       
    • AVX176 by Avaxia Biologics, is an investigational oral antibody drug patented to provide "Antibody Therapy for Treatment of Diseases Associated with Gluten Intolerance." The patent, which expires on May 27 2029, provides broad coverage for treating celiac disease using orally administered antibodies produced by Avaxia's proprietary platform technology.
       
    • BL-7010, by BioLineRx, is a novel co-polymer for the treatment of celiac disease, which significantly reduces the immune response triggered by gluten.

      This drug has been shown in mice to reduce the immune system response that leads to intestinal damage and villous atrophy in celiac disease. BL-7010 actually binds to the gluten protein, reducing the protein's toxicity.The drug, with the gluten molecule attached, then passes harmlessly through the digestive system to be expelled as stool.

      BL-7010 has undergone safety testing in humans and was found to be well tolerated. According to BioLineRx, testing will begin in mid-2015 to see if the drug works as expected to diminish gluten's effects on the body.

      However, BL-7010 is designed to protect only against gluten cross-contamination; it won't allow people with celiac disease to eat large amounts of gluten.
       
    • CCR9, by Chemocentryx, is a drug called vercirnon, which is also known as Traficet-EN, or CCX282B), and was originally intended for patients with moderate-to-severe Crohn's disease. CCR9 has completed one Phase 2 trial in 67 patients with celiac disease. However, despite the completion of the trial several years ago, no results relating to celiac disease have been made public or published.
       
    • Egg Yolk Enzyme. Little is known about efforts to develop a celiac treatment that uses egg yolk to coat gluten and allow it to pass through the body undetected, thus preventing an adverse gluten reaction in sensitive individuals. Like most other drugs being developed, this treatment would work to prevent reactions to small amounts of gluten, rather than as a cure. 
       
    • Larazotide Acetate by Alba Therapeutics.

      How it works: Larazotide acetate blocks a protein that carries pieces of gluten across the gut, where immune cells can see them. Fasano and his colleagues found that this carrier protein, called zonulin, is overproduced by celiac patients after they eat gluten.

      Results of the most recent phase 2 trial of larazotide acetate, published in February 2015 in Gastroenterology. The volunteers who took the drug experienced fewer days with disease symptoms during the 12 week-long study.
       
    • Nexvax2, by ImmusanT, works much like an allergy shot. Nexvax2 exposes the immune system to gluten in a controlled way so that immune cells that are usually activated get turned off or eliminated.

      So far, Nexvax2 has completed a phase 1 trial showing it to be safe. More research is being done to test whether it is effective.

      Designed to work as a vaccine, Nexvax2 combines three proprietary peptides that elicit an immune response in celiac disease patients who carry the immune recognition gene HLA-DQ2. Similar to allergy shots, the vaccine is designed to reprogram gluten-specific T cells triggered by the patient's immune response to the protein.
       
    • ZED1227 by Dr. Falk Pharma and Zedira recently announced the start of phase I clinical trials for the drug candidate ZED1227, a direct acting inhibitor of tissue transglutaminase. The small molecule targets the dysregulated transglutaminase within the small intestine in order to dampen the immune response to gluten which drives the disease process.

    Stay tuned for updates and progress reports as these drugs work their way through their various trial phases.

    Finally, share your thoughts on all these celiac drugs in the development pipeline. Are you excited, wary, both? Let us know by commenting below.

    Source:


    User Feedback

    Recommended Comments



    Article's fine. Concept's disturbing. Eating a gluten-free diet is the free, already-proven cure for celiac and gluten-intolerance. They don't have to torture mice and likely other animals to find a "cure" for something that there already is a cure for. I imagine there is $$ for the researchers here and $$ for the animal labs and $$ for the pharmaceuticals. What about all the other types of food allergies out there and what about all the GMOs headed our way that we don't really know how bodies will react to long term? Perhaps if we are mindful of what we eat and what we produce for food, we wouldn't have to turn this into a pharmaceutical company's dream. Those of us who find the gluten free diet healthy and fine, have no problem limiting what we eat and will not want to be shoved into a world where everyone is expected to take a pill and many gluten free options begin to disappear.

    Share this comment


    Link to comment
    Share on other sites

    It's a good article, about a subject I don't really understand. I'm a celiac and I have a cure; I don't eat gluten. As long as I stick to it, I feel great. I cannot imagine risking my situation, and risking whatever side effects may appear, to take a drug so I could eat gluten.

    Share this comment


    Link to comment
    Share on other sites

    I react immediately to any gluten that I am exposed to, but I am too old to join any trials. I eat a !00% gluten-free diet, unless someone else cooks and says the food is gluten-free and it is not.

    I hope the younger patients will have a cure.

    Share this comment


    Link to comment
    Share on other sites
    Guest Virginia Williams

    Posted

    Would love to have something to take for my celiac disease - hopefully something will be out soon - wondering if there is something out already that I do not know about - would love to know if there is.

    Share this comment


    Link to comment
    Share on other sites

    I am anxiously waiting for the outcome of the tests and availability of magical medicine. I don't know if i can be a part of any trial or not (Though I am willing and interested) as I am from Pakistan.

    Share this comment


    Link to comment
    Share on other sites

    Folks, from what I understand, these drugs are not "cures" and do not mean you can go crazy and eat all the gluten you want.

     

    For most of them, they are meant to reduce symptoms from ingesting small amounts of gluten, generally from accidental ingestion/cross-contamination, etc.

    Share this comment


    Link to comment
    Share on other sites

    An interesting article but I agree with Mars and Avwalters. A gluten-free diet is THE treatment for Celiac. I know that many Celiacs wish they could eat gluten products again (it's certainly what I grew up with) but on the brighter side gluten products are not, for the most part, healthy foods and in the long run we are better off without them (certainly true for me anyway).

    I would never take a pill so I could eat gluten again. Gluten is a poison to me and the pharmaceuticals could end up being the same with as yet unknown side effects. Not worth any risk IMHO.

    Share this comment


    Link to comment
    Share on other sites
    Article's fine. Concept's disturbing. Eating a gluten-free diet is the free, already-proven cure for celiac and gluten-intolerance. They don't have to torture mice and likely other animals to find a "cure" for something that there already is a cure for. I imagine there is $$ for the researchers here and $$ for the animal labs and $$ for the pharmaceuticals. What about all the other types of food allergies out there and what about all the GMOs headed our way that we don't really know how bodies will react to long term? Perhaps if we are mindful of what we eat and what we produce for food, we wouldn't have to turn this into a pharmaceutical company's dream. Those of us who find the gluten free diet healthy and fine, have no problem limiting what we eat and will not want to be shoved into a world where everyone is expected to take a pill and many gluten free options begin to disappear.

    Eating gluten-free does not cure celiac disease. It causes most of the symptoms to go away. If you eat gluten again, for a long enough period, the celiac disease returns. A gluten-free diet is a treatment, not a cure.

    Share this comment


    Link to comment
    Share on other sites



    Join the conversation

    You are posting as a guest. If you have an account, sign in now to post with your account.
    Note: Your post will require moderator approval before it will be visible.

    Guest
    Add a comment...

    ×   Pasted as rich text.   Paste as plain text instead

      Only 75 emoji are allowed.

    ×   Your link has been automatically embedded.   Display as a link instead

    ×   Your previous content has been restored.   Clear editor

    ×   You cannot paste images directly. Upload or insert images from URL.


  • 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.

×
×
  • Create New...