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An Update on Every Celiac Disease Drug Currently in Development

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

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:

Celiac.com welcomes your comments below (registration is NOT required).



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25 Responses:

 
Mar
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
24 Aug 2015 6:01:06 AM PST
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.

 
Jefferson
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said this on
25 Aug 2015 3:46:13 PM PST
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.

 
Mar
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said this on
07 Sep 2015 1:07:34 PM PST
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.

 
avwalters
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said this on
24 Aug 2015 7:11:15 AM PST
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.

 
Lorraine Lunz
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said this on
24 Aug 2015 7:55:04 AM PST
I react immediately to any gluten that I am exposed to, but I am too old to join any trials. I eat a !00% GF diet, unless someone else cooks and says the food is GF and it is not.
I hope the younger patients will have a cure.

 
Virginia Williams
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said this on
24 Aug 2015 1:47:57 PM PST
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.

 
PamLevy
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said this on
24 Aug 2015 3:11:55 PM PST
I have BX proven Celiac. Are there any trials I can participate in in OKC area? THAT'S what I would like to know.

 
Csnewmark
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said this on
24 Aug 2015 3:26:38 PM PST
Need more details.

 
Nancy
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said this on
24 Aug 2015 4:05:29 PM PST
I am excited..hope to have a Real hamburger in the next few years ?

 
Khawaja Adeel
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said this on
24 Aug 2015 10:21:36 PM PST
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.

 
Halle
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said this on
25 Aug 2015 12:58:59 PM PST
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.

 
Linda
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said this on
25 Aug 2015 3:03:13 PM PST
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.

 
linen53
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said this on
25 Aug 2015 4:53:29 PM PST
Thank you for the update.

 
Kris
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said this on
26 Aug 2015 6:47:07 AM PST
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 GF 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.

 
Jefferson
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said this on
31 Aug 2015 3:46:29 PM PST
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.

 
Rita
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said this on
31 Aug 2015 8:02:17 AM PST
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.

 
Tracy
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said this on
31 Aug 2015 9:29:30 AM PST
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 GF 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.

 
jean
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said this on
31 Aug 2015 11:40:27 AM PST
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.

 
DeeDee
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said this on
18 Sep 2015 8:01:47 AM PST
Amen!

 
Rebecca
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said this on
31 Aug 2015 2:28:19 PM PST
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 CD, there are so many on the market. (btw she is on a 100% GF diet) Please let me know if you have a good reference for me. Thanks so much for all your helpful info!!

 
Jefferson
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said this on
01 Sep 2015 2:43:52 PM PST
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.

 
Wayne W
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said this on
01 Sep 2015 4:50:45 AM PST
Great article, agree the eating GF is not a cure. I do it but miss out on all the good stuff. I want my life back and am excited about a possible solution soon!

 
Anonymouse
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said this on
01 Sep 2015 9:41:40 AM PST
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.

 
k swar
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said this on
21 Sep 2015 10:32:09 AM PST
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.

 
Carolyn Huntington
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said this on
21 Sep 2015 6:24:41 PM PST
While I cannot imagine eating gluten safely without some kind of new symptoms as there is usually a price to pay when medications are used and sometimes the side effects are worse than the original problem. Which I am sure is a big concern for everyone as our health improves so much on a gluten free diet (especially a healthy GF diet). Obviously it will be very important what type of side effects go along any pill. But I for one really pray for both my daughter and I that something turns out to be very effective at least with cross contamination without causing a lot of new problems. Too often finding food that is safe and not cross contaminated eating out is still a big problem.




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