Jump to content
This site uses cookies. Continued use is acceptance of our Terms of Use and Privacy Policy. More Info... ×
  • Welcome to Celiac.com!

    You have found your celiac tribe! Join us and ask questions in our forum, share your story, and connect with others.




  • Celiac.com Sponsor (A1):



    Celiac.com Sponsor (A1-M):


  • Get Celiac.com Updates:
    Help Celiac.com:
    eNewsletter
    Donate
  • Jefferson Adams
    Jefferson Adams

    Glutenase ALV003 Protects Celiacs Against Gut Damage from Gluten

    Reviewed and edited by a celiac disease expert.
    Glutenase ALV003 Protects Celiacs Against Gut Damage from Gluten - Photo: Wikimedia Commons--amitchel125
    Caption: Photo: Wikimedia Commons--amitchel125

    Celiac.com 06/02/2014 - Despite following a gluten-free diet, many people with celiac disease continue to have symptoms, and to suffer from ongoing small intestinal inflammation. Can a drug be created to alleviate such symptoms and inflammation, and protect celiacs on a gluten-free diet against small amounts of gluten contamination?

    San Carlos California-based Alvine Pharmaceuticals is conducting a phase 2 trial to determine whether their drug, ALV003, an orally administered mixture of 2 recombinant gluten-specific proteases can protect celiac disease patients from gluten-induced mucosal damage. For this trial, Alvine is working with researchers Marja-Leena Lähdeaho, Katri Kaukinen, Kaija Laurila, Pekka Vuotikka, Olli-Pekka Koivurova, Tiina Kärjä-Lahdensuu, Annette Marcantonio, Daniel C. Adelman, and Markku Mäki.

    Celiac.com Sponsor (A12):
    They are affiliated with the School of Medicine and Tampere University Hospital at the University of Tampere; the Department of Gastroenterology and Alimentary Tract Surgery at Tampere University Hospital and School of Medicine at the University of Tampere, and FinnMedi Oy in Tampere, Finland; the Department of Medicine at Seinäjoki Central Hospital in Seinäjoki, Finland; Liikuntaklinikka, Oulu Diakonissalaitos; and Terveys, Oulu Diakonissalaitos, Oulu, Finland.

    For their Phase 2 trial, the research team first established two grams of gluten per day as the optimal challenge dose for their 6-week gluten study. They then randomly assigned 20 adults with biopsy-proven celiac disease to receive ALV003, and twenty-one to receive a placebo. Both groups also received 2 grams of gluten each day. The team conducted duodenal biopsies at baseline, and after gluten challenge, focusing on the ratio of villus height to crypt depth and densities of intraepithelial lymphocytes.

    A total of seven patients dropped out due to adverse reactions. Four were receiving ALV003, and three were receiving the placebo. Sixteen patients given ALV003 and 18 given placebo were eligible for efficacy evaluation. Biopsies from subjects in the placebo group showed evidence of mucosal injury after gluten challenge, with average villus height to crypt depth ratio changed from 2.8 before challenge to 2.0 afterward. (P = .0007; density of CD3þ intraepithelial lymphocytes changed from 61 to 91 cells/mm after challenge; P = .0003).

    However, the team saw no significant mucosal deterioration in biopsies from the ALV003 group. The two groups showed no significant differences in symptoms, though they did show substantial differences in morphologic changes, and CD3þ intraepithelial lymphocyte counts differed significantly from baseline to week 6 (P = .0133 and P = .0123, respectively). This small, but important, step means that ALV003 did provide significant protection against gluten-induced gut damage for people with celiac disease on an otherwise gluten-free diet, which means that Alvine can continue to the next phases in the development process.

    If successful, glutenase ALV003 will be the first drug to protect people with celiac disease against gut damage from small amounts of gluten.

    Source:

    • Clinicaltrial.gov, Numbers: NCT00959114 and NCT0125569


    User Feedback

    Recommended Comments

    Guest Lee

    Interesting article. I have celiac disease. Hoping for more help than a gluten-free diet.

    Link to comment
    Share on other sites
    Guest BobbyT

    Where can I buy glutenase?

    Link to comment
    Share on other sites
    Scott Adams

    It's not available and in clinical trials I believe.

    Link to comment
    Share on other sites


    Create an account or sign in to comment

    You need to be a member in order to leave a comment

    Create an account

    Sign up for a new account in our community. It's easy!

    Register a new account

    Sign in

    Already have an account? Sign in here.

    Sign In Now

  • Get Celiac.com Updates:
    Help Celiac.com:
    Donate
  • 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. His articles, essays, poems, stories and book reviews have appeared in numerous magazines, journals, and websites, including North American Project, Antioch Review, Caliban, Mississippi Review, Slate, and more. He is the author of more than 2,500 articles on celiac disease. His university coursework includes studies in science, scientific methodology, biology, anatomy, physiology, medicine, logic, and advanced research. He previously devised health and medical content for Colgate, Dove, Pfizer, Sharecare, Walgreens, and more. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of numerous books, including "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

    >VIEW ALL ARTICLES BY JEFFERSON ADAMS

     


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





    Celiac.com Sponsors (A17-M):




  • Related Articles

    Jefferson Adams
    Celiac.com 10/26/2010 - A recent study shows that, since 1974, the rate of celiac disease has doubled every fifteen years, and that celiac rates increase as people grow older, with many developing the disease in their 50s or 60s.
    The Center for Celiac Research led the study, which looked at 3,511 volunteers who submitted blood samples in 1974 and 1989, along with updates every two to three years until 2007.
    Because researchers in the study surveyed the same people over time, says Mayo Clinic gastroenterologist Dr. Joseph Murray, the study adds weight to the concept that celiac disease can emerge at any age.
    The study results also echo those of a 2008 Finnish study that found that elderly people had rates of celiac disease nearly two and a half times higher than the general population...


    Jefferson Adams
    Celiac.com 02/23/2011 - In most adults with celiac disease, clinical symptoms disappear with a gluten-free diet. However, the exact effects of a gluten-free diet on rates of mucosal recovery in adults with celiac disease is less certain.
    A group of clinicians recently set out to assess rates of mucosal recovery under a gluten-free diet in adults with celiac disease, and to gauge the clinical prospects of ongoing mucosal damage in celiac patients who follow a gluten-free diet.
    The study group included Alberto Rubio-Tapia, MD; Mussarat W. Rahim, MBBS; Jacalyn A. See, MS, RD, LD; Brian D. Lahr, MS; Tsung-Teh Wu, MD; and Joseph A. Murray, MD.
    Each patient in the study had biopsy-proven celiac disease, and was assessed at the Mayo Clinic. Also, each patient received duodenal biopsies...


    Jefferson Adams
    Celiac.com 08/11/2014 - A study establishing the existence of non-celiac gluten sensitivity has been turned on its head; by the very scientist who conducted it. In 2011, a small but scientifically rigorous study found that dietary gluten can trigger gastrointestinal distress in people without celiac disease. That study was conducted by Peter Gibson at Monash University in Australia.
    Last year, Gibson published a follow-up study, which indicated that the real culprit might not be gluten, but fermentable, poorly absorbed short-chain carbohydrates known as FODMAPs. Specifically, Gibson’s second study found no effects of gluten in patients with self-reported non-celiac gluten sensitivity after dietary reduction of fermentable, poorly absorbed, short-chain carbohydrates. That is, once t...


    Jefferson Adams
    Celiac.com 10/14/2014 - A new drug designed to prevent gluten uptake in the gut is showing some promise for the treatment of celiac disease.
    The drug, larazotide acetate, significantly reduced symptoms in a large double-blind, placebo-controlled trial. The drug prevents gluten uptake by closing tight junctions in the gastrointestinal (GI) tract.
    The drug is intended to supplement, rather than replace, the gluten-free diet that makes up the standard celiac disease treatment. Specifically, the drug is designed to help patients who continue to experience symptoms despite efforts to avoid gluten, and will not allow celiac patients to eat gluten with impunity.
    Some experts are cautioning celiac disease patients against high expectations. Joseph A. Murray, MD, of the Division of Gastroenterology...


  • Recent Activity

    1. - Hannah24 replied to Hannah24's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      7

      Negative Test but I have All the Symptoms!

    2. - Hannah24 replied to Hannah24's topic in Celiac Disease Pre-Diagnosis, Testing & Symptoms
      7

      Negative Test but I have All the Symptoms!

    3. - trents replied to Linedancegal's topic in Introduce Yourself / Share Stuff
      4

      25 year biopsy confirmed/ate pizza with no ill effects?

    4. - Moodiefoodie replied to Moodiefoodie's topic in Related Issues & Disorders
      2

      Joint swelling when ill even on gluten-free diet

    5. - knitty kitty replied to Holly15892's topic in Post Diagnosis, Recovery & Treatment of Celiac Disease
      7

      Growth spurt after diagnosis in adulthood


  • Celiac.com Sponsor (A19):



  • Member Statistics

    • Total Members
      120,466
    • Most Online (within 30 mins)
      7,748

    CtoThaE
    Newest Member
    CtoThaE
    Joined

  • Celiac.com Sponsor (A20):


  • Forum Statistics

    • Total Topics
      120.2k
    • Total Posts
      1m

  • Celiac.com Sponsor (A22):





  • Celiac.com Sponsor (A21):



  • Popular Now

    • Linedancegal
    • Hannah24
      7
    • jessiemariecar
    • Rhonda H
    • HayleyC123
  • Popular Articles

    • Scott Adams
    • Scott Adams
    • Scott Adams
    • Scott Adams
    • Scott Adams
  • Upcoming Events

×
×
  • Create New...