Jump to content
  • Sign Up
  • Join Our Community!

    Get help in our celiac / gluten-free forum.

  • Tina Turbin
    Tina Turbin

    New Drug Shows Promise in Celiac Disease Clinical Trials

    Reviewed and edited by a celiac disease expert.

    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.

    Photo: CC--SLU Madrid CampusNow 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.


    User Feedback

    Recommended Comments

    Guest Rebecca Lockhart

    Posted

    I am very glad to see the research resulting in new treatments. Like many others, maintaining that gluten-free diet, along with my diabetes diet feels truly overwhelming at times.

    Share this comment


    Link to comment
    Share on other sites
    I don't trust drug companies. What are the side effects?

    Side effects? Really?

    You might not get sick with an accidental exposure outside of your normal strict Coeliac diet!

     

    I for one would really welcome a safety net option...

    Share this comment


    Link to comment
    Share on other sites

    I am enthused to see there is research being done to potentially treat celiac disease. Although I am holistic and prefer not to take prescription medications (unless needed), I believe if there are many holistic approaches to treating celiac. Naturepath doctors' would be a great group of people to consult with regarding AV003. Furthermore, humans were never suppose to eat foods containing gluten. People that suffer with celiac are the mutants because their bodies reject the toxins found in gluten. I've suffered with celiac for 16 years and I was finally diagnosed after suffering for 14 years. Good luck to all my fellow celiac friends. Cheers, AV003.

    Share this comment


    Link to comment
    Share on other sites
    I am enthused to see there is research being done to potentially treat celiac disease. Although I am holistic and prefer not to take prescription medications (unless needed), I believe if there are many holistic approaches to treating celiac. Naturepath doctors' would be a great group of people to consult with regarding AV003. Furthermore, humans were never suppose to eat foods containing gluten. People that suffer with celiac are the mutants because their bodies reject the toxins found in gluten. I've suffered with celiac for 16 years and I was finally diagnosed after suffering for 14 years. Good luck to all my fellow celiac friends. Cheers, AV003.

    Actually, I was on a clinical trial in OKC for many months. I was one who actually received the blocker. It works with no side affects. While on the trial I had several endoscopic procedures with no trauma signs. I was very thankful to have been apart of the study and for not receiving the placebo blocker.

    Share this comment


    Link to comment
    Share on other sites
    It would be AWESOME to have a huge slice of thick crust pizza, a piece of my wife's apple pie or a great burger.

    get it done already!!!

    Figaroe has gluten free pizza crust and it is VERY good.

    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

    Tina Turbin is a world-renowned Celiac advocate who researches, writes, and consults about the benefits of the gluten-free, paleo-ish, low carb and keto diets, and is a full time recipe developer and founder of PaleOmazing.com. Tina also founded and manages the popular website, GlutenFreeHelp.info, voted the #2 .info website in the world. Tina believes that celiacs need to be educated to be able to make informed decisions and that Paleo needs to be tailored to the individual’s physiology to obtain desired results. You can reach her at: INFO@PaleOmazing.com.

×
×
  • Create New...