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  • 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.

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    Ok folks, lets read the article shall we? The article does mention that the majority of the drugs are designed with the intent of assisting celiac patients with avoiding a cross-contamination reaction, not that we can just start consuming gluten in large quantities.

    For myself, as a very sensitive celiac, this could be life changing. I can't go to most places where there is a gluten-free menu (in addition with regular fare) as many kitchen staff do not have the proper training to ensure safe food handing. The fall out is simply not worth it, I get too sick, for too long to risk it. If a little pill could allow me to occasionally go out for dinner or travel more easily with my husband and child, and allow me to eat without fear, (not start eating gluten again, mind) it would enhance my quality of life beyond measure.

     

    I am not in love with big pharma by any means, and avoid medication whenever possible, however, when there is a need, there is a need. There have been MANY medical advances have improved quality of life for countless individuals the world over. Let's not forget how a short time ago people died from now treatable diseases. Its not always bad.

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    Just like many of the commenters here, I am skeptical of any medications when diet is so effective and free. However, I would like to open my social life up a bit and it would be great to be able to occasionally take a pill before going to a party or wedding reception or a professional conference or a festival or a sporting event, any activity in which people eat. And would make travel or hurricane evacuation much much easier. I don't even miss wheat anymore, but I do miss the camaraderie of socializing over a good meal. I am excited at the possibilities.

     

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    Thank you, Kris! I could not agree with you more. Great article. Please continue to keep us informed on these advances in media. I would LOVE to be able to eat at a restaurant or a friends house and not have to worry about cross contamination. I will always maintain a gluten-free diet. I have no need to eat something my body does no tolerate. However, no matter how many steps I take, eating outside my own kitchen is always a risk. If I could take a pill during those times and not have a reaction due to cross contamination or the food preparer's oversight, it would improve my quality of life. No one wants to live in a bubble.

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    Being totally gluten free (5 1/2 yrs) hasn't helped me much. Still disabled by pain, fatigue, abdominal swelling. Now, if you had a treatment for that...I would welcome it.

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    Jefferson, excellent article and thank you for an update and summary in one place of the latest research on celiac treatments. I was wondering if you have a source for best digestive enzyme product for celiacs to take? My 14 year old daughter has Celiac and Hashimoto's and I believe digestive enzymes are a very important aid in a healthy life for her, just not sure if there are some better than others for people with celiac disease, there are so many on the market. (btw she is on a 100% gluten-free diet) Please let me know if you have a good reference for me. Thanks so much for all your helpful info!!

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    Ok folks, lets read the article shall we? The article does mention that the majority of the drugs are designed with the intent of assisting celiac patients with avoiding a cross-contamination reaction, not that we can just start consuming gluten in large quantities.

    For myself, as a very sensitive celiac, this could be life changing. I can't go to most places where there is a gluten-free menu (in addition with regular fare) as many kitchen staff do not have the proper training to ensure safe food handing. The fall out is simply not worth it, I get too sick, for too long to risk it. If a little pill could allow me to occasionally go out for dinner or travel more easily with my husband and child, and allow me to eat without fear, (not start eating gluten again, mind) it would enhance my quality of life beyond measure.

     

    I am not in love with big pharma by any means, and avoid medication whenever possible, however, when there is a need, there is a need. There have been MANY medical advances have improved quality of life for countless individuals the world over. Let's not forget how a short time ago people died from now treatable diseases. Its not always bad.

    I agree! I think that very sensitive celiac sufferers might benefit tremendously from safe treatments that might prevent low levels gluten contamination from causing any problems. I think that would be great for many people.

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    This is really exciting. If these drugs do work, we might have to get some for those times that we eat out or at someone else's house. You know, the times when you think things are gluten free, but you can't be 100% sure. I would absolutely love to have some kind of backup to make me feel safe outside the home as well.

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    Jefferson, excellent article and thank you for an update and summary in one place of the latest research on celiac treatments. I was wondering if you have a source for best digestive enzyme product for celiacs to take? My 14 year old daughter has Celiac and Hashimoto's and I believe digestive enzymes are a very important aid in a healthy life for her, just not sure if there are some better than others for people with celiac disease, there are so many on the market. (btw she is on a 100% gluten-free diet) Please let me know if you have a good reference for me. Thanks so much for all your helpful info!!

    Be careful of digestive enzymes, as many do not fully degrade gluten. I did an article on this recently. The only bright spot from the article was this: "In contrast, the pure enzyme AN-PEP effectively degraded all nine epitopes in the pH range of the stomach at much lower dose."

     

    Based on that, I would consider AN-PEP, but I am not a doctor, and that's strictly a personal, not a medical, opinion. An opinion based on research, not personal experience, so definitely take it with a grain of salt and use your own judgement.

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    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.

    Yes, you are correct. Gluten free diet is a treatment not a "cure". Bad word choice on my part. The treatment of a gluten free diet is good enough for me for all the reasons I listed.

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    Being totally gluten free (5 1/2 yrs) hasn't helped me much. Still disabled by pain, fatigue, abdominal swelling. Now, if you had a treatment for that...I would welcome it.

    Amen!

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    Thank you. For almost 10 years I have had to order, caution, not eat, etc. because of celiac. A pill to protect against small amounts of gluten and still maintain a gluten free diet would be a blessing.

    Gluten free food is very expensive and mostly tasteless. And it is not a very healthful diet. Cure would be great but I will take protection of sorts for the moment. Report was great.

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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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