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  • Jefferson Adams
    Jefferson Adams

    Will a New Enzyme Mean No More Gluten-Free Diet for Celiac Disease?

    Reviewed and edited by a celiac disease expert.

      There is nothing that is approved by the FDA for celiac disease


    Caption: Image: CC--sevier medical art

    Will a new treatment enable people with celiac disease to ditch a gluten-free diet?

    About one in a hundred people in the United States is affected by celiac disease. If you're one of them, you know how hard it can be to maintain a strict gluten-free diet.

    Everyone's got their horror stories about trying to simply eat a meal, only to have a tiny amount of gluten wreck havoc on their digestive system.

    There are currently no therapeutics on the market to treat celiac disease, says Sydney Gordon, a scientist at Ab Initio Biotherapeutics. Sure, there are other over-the-counter enzyme treatments, Gordon adds, but most are slow to act, or don't break down enough gluten to prevent a reaction.

    "There are no other enzymes on the market for celiac disease," said Justin Siegel, the co-founder of PvP Biologics and an assistant professor of chemistry, biochemistry and molecular medicine at UC Davis. "There is nothing that is approved by the FDA for celiac disease. Nothing has made it through clinical trials. There are pills on the market that cause degradation of gluten, but there is no clinical evidence that they are effective."

    "We wanted to design an enzyme […] a protein that would act as a therapeutic for celiac disease. We came up with a design using a protein modeling tool called FoldIt," said Ingrid Pultz, a co-founder of PvP Biologics.

    PvP Biologics enzyme therapy works by targeting the exact triggering molecule, the immunogenic epitope, before it gets to the intestine and causes an immune reaction.

    To do this, PvP Biologics uses kumamolisin, a naturally occurring enzyme that, unlike some other enzymes, can survive the acidity of the stomach. By modifying the amino acid sequence in the original kumamolisin enzyme, researchers were able to specifically target the epitope causing the reaction.

    If the therapy proves successful, many celiac patients won't have to worry about minute amounts of cross-contamination when eating outside.

    Those are pretty strong claims. Many people with celiac disease might likely say that it sounds too good to be true. Still, the company is moving in a direction that few others have gone. No word on if or when we might expect to see a finished treatment come to market. For all the company's claims, there is much to work out, and a long, winding road to get FDA approval.

    Stay tuned to see if the evidence from trials and from potential consumer use supports those claims.

    Read more at TheAggie.org.

    Editor's note: We've received a correction on this story from PvP Biologics, makers of KumaMax, which states that their product is designed for accidental gluten ingestion, and not as a replacement for a gluten-free diet in people with celiac disease. Their enzyme could lessen the effects of accidental consumption of small amounts of gluten.


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    On their website, PvP Biologics states that, "we are advancing a product candidate designed to break down the immuno-reactive parts of gluten in the stomach and thereby avoid the painful symptoms and damage done in the small intestine from accidental gluten ingestion." They are very clear that this is not a product that will eliminate the need for a gluten-free diet, and they state several times on their site (pvpbio.com) that the therapy is for accidental ingestion of gluten. You need to correct this article. Whatever Sydney Gordon said, it's clear she doesn't speak for PvP.

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    On their website, PvP Biologics states that, "we are advancing a product candidate designed to break down the immuno-reactive parts of gluten in the stomach and thereby avoid the painful symptoms and damage done in the small intestine from accidental gluten ingestion." They are very clear that this is not a product that will eliminate the need for a gluten-free diet, and they state several times on their site (pvpbio.com) that the therapy is for accidental ingestion of gluten. You need to correct this article. Whatever Sydney Gordon said, it's clear she doesn't speak for PvP.

    We've added a note regarding this.

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    I think the "accidental gluten ingestion" information needs to be more than just an addendum! It negates the whole article for those of us with celiac disease. I got my hopes raised reading this article only to have them cruelly dashed by the note at the end.

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    I think the "accidental gluten ingestion" information needs to be more than just an addendum! It negates the whole article for those of us with celiac disease. I got my hopes raised reading this article only to have them cruelly dashed by the note at the end.

    I totally agree. However, I have to say that I'm glad to read about cure research. Maybe it'll be possible for us to eat "normally" some day. With all I've learned about cooking over the past 15 years, living with celiac disease, I wonder what I could do with non-gluten-free ingredients. As I see it, we'll still have to wait.

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    I think the "accidental gluten ingestion" information needs to be more than just an addendum! It negates the whole article for those of us with celiac disease. I got my hopes raised reading this article only to have them cruelly dashed by the note at the end.

    Sorry to dash your hopes. There are numerous enzyme treatments currently under development. There are also many claims being made about the efficacy of those enzymes, hence the title of the article. Those claims almost always come with caveats, hence the fine print about the enzyme being intended for "accidental gluten ingestion" only. We are all hoping for a major breakthrough, so stay tuned.

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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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