Jump to content



Celiac.com Sponsor (A1):



Celiac.com Sponsor (A1-m):


  • You've found your Celiac Tribe! Join our like-minded, private community and share your story, get encouragement and connect with others.

    💬

    • Sign In
    • Sign Up
  • Jefferson Adams
    Jefferson Adams

    Can a New Drug Eliminate a Gluten-Free Diet for Celiac Disease Patients?

    Reviewed and edited by a celiac disease expert.

    A new oral drug for treating celiac disease could allow people with celiac disease to safely consume wheat, eliminating the need for a gluten-free diet. The drug was recently granted status as a new investigational drug (IND) by the FDA.

    Can a New Drug Eliminate a Gluten-Free Diet for Celiac Disease Patients? - Image: CC BY-SA 4.0--Bastet78
    Caption: Image: CC BY-SA 4.0--Bastet78

    Celiac.com 09/09/2019 - A new oral drug for treating celiac disease could allow people with the disease to safely consume wheat, eliminating the need for a gluten-free diet. Capsules of ActoBiotics AG017 from ActoBio Therapeutics were recently granted new investigational drug (IND) status by the US Food and Drug Administration (FDA). 

    The drug contains a customized version of the bacterium Lacotococcus lactic, designed to express a gliadin peptide, coupled with an immunomodulating cytokine. The drug can be administered orally or topically, and so requires no injections.



    Celiac.com Sponsor (A12):






    Celiac.com Sponsor (A12-m):




    According to the company, ActoBiotics therapies promote antigen-specific immune tolerance that can prevent or reverse certain autoimmune and allergic diseases. AG017 is an antigen-specific celiac therapy with the potential to reverse gluten sensitivity that is aimed at the over 90% of celiac patients with the HLA-DQ2.5 genotype that responds to its immunomodulating cytokine.

    The drug will begin a Phase Ib/IIa study in patients with celiac disease in the US and Europe later in 2019.

    What do you think? Promising? Or likely more hype? Over the years, the celiac disease community has heard much about the promise of new drugs and treatments touting their ability to eliminate the need for a gluten-free diet, but nothing has come of it. We'll be keeping an eye on this drug to see how it pans out, so stay tuned.



    User Feedback

    Recommended Comments



    I don’t know what is worse. My celiac disease was triggered by an operation  when I was 63 years old. So the transition from gluten food to gluten free was horrible for me. I am a taste and texture person. I don’t think I would have rather had it from my early years but it is so horrible for me. I am now 71 years old and I still can’t get use to gluten free. If this new med works the first 3 things I can’t wait to eat again are pizza, bagels, and a hamburger with a regular roll.

    Link to comment
    Share on other sites

    Very exciting news! I was diagnosed with celiac disease in 2013 when I was 57 years old. I am also allergic to dairy and have to eat low FODMAP because of IBS. While I have to be skeptical that this would help me, it does give me a little hope that maybe I can eat more normally again! Thank you for alerting us to this development.

    Link to comment
    Share on other sites
    9 hours ago, Guest Guest Larry said:

    I don’t know what is worse. My celiac disease was triggered by an operation  when I was 63 years old. So the transition from gluten food to gluten free was horrible for me. I am a taste Wand texture person. I don’t think I would have rather had it from my early years but it is so horrible for me. I am now 71 years old and I still can’t get use to gluten free. If this new med works the first 3 things I can’t wait to eat again are pizza, bagels, and a hamburger with a regular roll.

    Well, all I can recommend to you, Sir, is to move to Finland! They have the BEST gluten-free products I have EVER tasted anywhere! Hands down! And I'm not saying this because I'm a Finn living in the U.S., but because I've lived in many countries before moving here, and tasted gluten-free products in all of them, yet nothing has come even close to what you can find in Finland. Already 30 years ago when I was diagnosed with the celiac myself, there were a lot of tasty products I could buy - and they've even had gluten-free hamburgers at every single hamburger joint 20 years back already, do they have it here? Nope, not a single hamburger place has them, not a single one, I've tried, only in restaurants do they offer, and they're a far cry from the authentic ones - so, in short, if you ever think of traveling for a vacation somewhere in Europe, I suggest you visit Finland! You won't get disappointed! Anything that you can buy normal, you can get gluten-free also! Even in gas station bars - sandwiches and all, gluten-free versions are handmade for you, all you need to do is ask ? and of course, hygiene standards are superior, the national health organization wouldn't give a permit for anyone to prepare gluten-free foods, unless the working environment was completely free from gluten allergens. So dont despair, Sir, not everything is lost yet! ✌?

    Link to comment
    Share on other sites

    I am hoping for a drug like this ,I have been super sentive to gluten since I was in my 20s ,it's painful when I eat out as lots of people don't know what gluten does to coeliacs, so I'm limited to eating out ,it would be wonderful to go and eat anything I like made with gravy without the worry of the pain when I go to sleep if it contained even the slightest bit of gluten ,last time they said they had a drug ,I was so disappointed,as it never came true I would like to trial the drugs ,if it was possible I'm 62 years of age now been on this diet for around 45 years now be nice to have a break please keep on with your great work .

    Link to comment
    Share on other sites
    19 hours ago, Guest Dante Fishell said:

    I’m really hoping, my 16 yr old daughter has had celiac disease since she was 18mo and although we’re doing great there have been and still times it  mentally affects her. So I hope for her and other kids they can solve this!

    I am in your same position with my 14yo son. He was diagnosed late (8yo) because he wasn't thriving. He weighed just 68 pounds. Now, while he has gotten used to the diet, mentally  it does take a toll on him. Something has got to work. Praying!

    Link to comment
    Share on other sites
    11 hours ago, Guest Guest Larry said:

    I don’t know what is worse. My celiac disease was triggered by an operation  when I was 63 years old. So the transition from gluten food to gluten free was horrible for me. I am a taste and texture person. I don’t think I would have rather had it from my early years but it is so horrible for me. I am now 71 years old and I still can’t get use to gluten free. If this new med works the first 3 things I can’t wait to eat again are pizza, bagels, and a hamburger with a regular roll.

    I can relate to Larry.  I'm 69 and have only been gluten-free for 4 years, but I miss pizza and regular hamburg/hotdot rolls, too.  The gluten-free ones just aren't the same!  LiveG Free bagels are pretty good.   

    Link to comment
    Share on other sites
    22 hours ago, Guest Dante Fishell said:

    I’m really hoping, my 16 yr old daughter has had celiac disease since she was 18mo and although we’re doing great there have been and still times it  mentally affects her. So I hope for her and other kids they can solve this! 

    No matter the age the stigma and social isolation continues. Food commercials make me angry!  Many gluten-free processed foods contain gluten cross-reactors or sulfites and toxic heat processed oils.  Even if there were a pill that magically made gluten tolerable, would you still want to consume the proteins in wheat (gluten & gliaden) that produce inflammatory effects in the body?

    Link to comment
    Share on other sites
    10 hours ago, Guest Guest Larry said:

    I don’t know what is worse. My celiac disease was triggered by an operation  when I was 63 years old. So the transition from gluten food to gluten free was horrible for me. I am a taste and texture person. I don’t think I would have rather had it from my early years but it is so horrible for me. I am now 71 years old and I still can’t get use to gluten free. If this new med works the first 3 things I can’t wait to eat again are pizza, bagels, and a hamburger with a regular roll.

    I was diagnosed  when I was 60. That was 3years ago. I still have anger issues about it. I really hope this new drug works out. I'm going to eat the same things you are.?

    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.   Restore formatting

      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

    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 2,500 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.


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





    Celiac.com Sponsors (A17-m):




  • Related Articles

    Tina Turbin
    Celiac.com 11/30/2011 - Researchers have been talking about it for some time, raising the hopes of the celiac community: a drug to help relieve us from the harmful effects of gluten exposure. Celiac patients are closer than ever to having such a drug on the market, as Alvine Pharmaceuticals has announced that their drug ALV003 has shown promise in a clinical trial by reducing gluten-triggered harm in people with celiac disease.
    Celiac disease is an autoimmune reaction triggered by exposure to gluten, a protein found in wheat, barley, and rye, that causes the immune system to attack the small intestine, interfering with the absorption of nutrients and leading to malnutrition and a variety of other symptoms. The disease currently has only one treatment, which is non-drug: the gluten-free diet. By eliminating gluten completely from the diet, most celiac patients can heal their small intestine. There is currently no other drug on the market that can help relieve the symptoms of celiac disease or the intestinal damage it can cause.
    Now Alvine Pharmaceuticals, which is focused on developing biopharmaceuticals for autoimmune inflammatory diseases such as celiac disease, has reported favorable results for a trial with their drug ALV003, which was developed to lessen mucosal injury in the intestine caused by gluten exposure in well-controlled celiac patients.
    A control group study was conducted that collected data from 34 celiac patients. After both the active drug group and placebo group ingested two grams of gluten on a daily basis for six weeks, "The group with the placebo reported higher incidence of 'non-serious adverse events' (code for GI symptoms)," Triumph Dining reported. "They also had significantly more mucosal injury in their small intestines, as measured by biopsy data."
    ALV003 works by breaking down the gluten molecule into nontoxic parts. (Alvine Pharmaceuticals explains more specifically how the drug works on their website, AlvinePharma.com.) The drug is intended to help alleviate the gastrointestinal and other symptoms associated with cross-contamination, incorrect or misleading "gluten-free" labeling, and exposure to gluten caused by carelessness or imprudence. Even when celiac patients take care to maintain a strict gluten-free, it's difficult to stay completely away from gluten. That's why, according to coordinating investigator of the latest ALV003, Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, "New non-dietary treatment options that can either eliminate, or meaningfully reduce the gluten present in an attempted gluten-free diet are needed."
    Currently celiacs have no drug options to help alleviate their symptoms. "These results are groundbreaking," said Professor Maeki, "as they demonstrate for the first time, in a controlled clinical trial, that a drug has the potential to diminish gluten-induced injury in celiac disease patients."
    According to Triumph Dining, "After Phase 3 trials, so long as results remain promising, ALV003 will enter Phase 2b trials soon; after that come Phase 3 trials and (hopefully) submission to the FDA for approval." The release of ALV003, should results remain favorable, will no doubt bring relief to many members of the celiac community.



    Dr. Vikki Petersen D.C, C.C.N
    Celiac.com 06/23/2017 - Dr. Alessio Fasano from the University of Maryland's Celiac Research Center published a paper in Clinical and Developmental Immunology last month. It focused on a new drug developed by Dr. Fasano that has shown promising results in both animal and human trials. But is this the 'magic pill' that will cure celiac disease and gluten sensitivity? Let's take a look.
    The new drug, formerly called AT1001 but now renamed Larazotide Acetate, is a zonulin inhibitor. For those who have never heard the word 'zonulin', you might think it's a term from a science fiction movie. But zonulin is the protein that causes the 'gates' or openings between the cells making up the lining of the small intestine to open and close. These openings are called tight junctions and when zonulin gets excessive, a leaky gut ensues.
    Dr. Fasano has made great inroads to prove that a leaky gut is a problem that must be handled with gluten intolerance. The leaky gut perpetuates gluten's negative impact on other parts of the body. It can also initiate autoimmune disease.
    One key point to keep in mind is that 'leaky gut' occurs because molecules can pass between cells when they shouldn't. In addition, molecules can pass through cells which they also shouldn't. Unfortunately this new drug only impacts the former, not the latter.
    So, the drug Larazotide Acetate is a zonulin inhibitor. Now that we've reviewed what zonulin does as regards opening the gates, the purpose of inhibiting its action should make sense. How well does it work? In the recent human trials that were double-blind, randomized placebo-controlled (the best type of study, but I would expect no less from the stellar Dr. Fasano), a gluten exposure created a 70% increase in intestinal permeability (leaky gut) in 57% of the placebo group but only 28.6% of the patients receiving the drug (4 out of 14 patients) experienced such increased permeability.
    Further, gastrointestinal symptoms were significantly more frequent among patients of the placebo group as compared to the group that received the Larazotide.
    A pro-inflammatory substance known as interferon gamma was also evaluated. This is manufactured by the body when a specific foreign/toxic agent is recognized by the body's immune system. As expected, levels of interferon gamma increased in 4 out of 7 of the placebo patients (57%) but only 4 out of 14 larazotide patients (28.6%) saw any increase.
    The good news is that this drug seems well tolerated and it does reduce the leaky gut response that gluten ingestion normally creates. Further, it also reduces the percentage, by about half, of the production of interferon gamma. These are all excellent results.
    But, and it's unfortunately a very big 'but', we have a very long way to go before such a drug would be useful for your typical celiac or gluten sensitive patient. Will Dr. Fasano and his team be able to tweak this drug such that it functions at a higher level of efficacy? I certainly hope so, but let's analyze exactly what this drug does in its present state:
    The drug still resulted in almost 30% of the patients experiencing a 70% increase in permeability (leaky gut) – Not good. A highly pro-inflammatory (this means that it creates degenerative disease) substance known as interferon gamma was also produced in nearly 30% of the drug-consuming patients tested – Not good.
    Leakiness, or the passage of negative substances through cells is not affected by this drug – Not good.
    Of course on the plus side, over 70% of those tested DID have a very good result with apparently no untoward side effects – Very good.
    At what point is the efficacy high enough that you'd be willing to subject yourself to a possible reaction? Do realize that any gluten ingested increases your chance of disease, chief amongst them cancer and autoimmune disease. Is there a level of function of the drug that you would chance taking it? Is it 90%, 99%? Does any drug ever get that good?
    Well, as a big fan of Dr. Fasano's, I would say that if anyone can do it, he and his team can. But at the same time, I cannot help but think of all the other drugs I have encountered. As 'wonderful' as they sometimes seem initially, they almost always fall from grace when some horrible side effect is realized.
    Would I guinea pig my own health that I've fought so hard to regain? Would I recommend taking such a chance to my children just so that they could consume some white flour product? I don't think so.
    How about you? What do you think? If the drug were available right now at its efficacy of 71%, would you take it and hope you weren't in the 29% for whom it didn't work? I'd love to hear your thoughts.
    If you are wondering if you're gluten intolerant or know that you are but still aren't enjoying good health, consider calling us for a free health analysis: 408-733-0400. We are here to help! Our destination clinic sees patients from across the country and internationally so you do not need to live locally to receive assistance.
    To your good health!
    Reference:
    Alessio Fasano, Clinical and Developmental Immunology, Published online 2012 October 10. "Novel Therapeutic/Integrative Approaches for Celiac Disease and Dermatitis Herpetiformis."


    Jefferson Adams
    Celiac.com 05/25/2018 - People with celiac disease need to follow a lifelong gluten-free diet. However, once their guts have healed, they can still be sensitive to gluten. Sometimes even more sensitive than they were before they went gluten-free. Accidental ingestion of gluten can trigger symptoms in celiac patients, such as pain in the gut and diarrhea, and can also cause intestinal damage. 
    A new drug being developed by a company called Amgen eases the effects of people with celiac disease on a gluten-free diet. Researchers working on the drug have announced that their proof-of-concept study shows AMG 714, an anti-IL-15 monoclonal antibody, potentially protects celiac patients from inadvertent gluten exposure by blocking interleukin 15, an important mediator of celiac disease, and leads to fewer symptoms following gluten exposure.
    The drug is intended for people with celiac disease who are following a gluten-free diet, and is designed to protect against modest gluten contamination, not to permit consumption of large amounts of gluten, like bread or pasta.
    AMG 714 is not designed for celiac patients to eat gluten at will, but for small, incidental contamination. Francisco Leon, MD, PhD, study director and consultant for Amgen, says that their team is looking at AMG 714 “for its potential to protect against modest contamination, not deliberately eating large amounts of gluten, like bread or pasta.” 
    Amgen hopes that AMG 714 will help celiac patients on a gluten-free diet to experience fewer or less sever gluten-triggered events.
    Findings of the team’s first phase 2 study of a biologic immune modulator in celiac disease will be presented at the upcoming Digestive Disease Week 2018. 
    Read more at ScienceDaily.com


    Jefferson Adams
    Celiac.com 08/07/2018 - A new drug designed to reduce symptoms of accidental gluten ingestion in celiac disease sufferers has yielded some encouraging data. The drug in question is a monoclonal antibody designed to reduce adverse reactions in celiacs who are accidentally exposed to gluten. The results, presented at Digestive Disease Week, held in Washington DC from 2–5 June 2018, suggest that monoclonal antibodies could provide protection for people with celiac disease.
    Celiac patients on a gluten-free diet who randomly received six injections of a monoclonal antibody, called AMG 714, over a ten-week period, enjoyed a substantial reduction in intestinal inflammation. Over a ten week study period, celiac patients on a gluten-free diet received six randomly assigned injections of either a placebo, or of AMG 714 at a dose of either 150mg or 300mg. 
    Patients then underwent a dietary gluten challenge from week through until week twelve. As tested, the drug did not reduce damage to intestinal villi for either treatment group, which was the trial’s primary goal, but it did significantly reduce celiac-related inflammation and symptoms in response to gluten consumption.
    Patients receiving the highest dose of AMG 714 had no clinically active disease at week twelve of the study, and also had a significant improvement in self-reported outcomes, compared with the placebo group. No matter how diligently people with celiac disease follow a gluten-free diet, they can still suffer accidental gluten exposure ingestion.
    Treatments like AMG 714 could become important adjunct to gluten-free diet in for people with celiac disease, including non-responsive celiac disease.
    Read more in Pharmaceutical-journal.com


  • Popular Now

×
×
  • Create New...