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  • Jefferson Adams
    Jefferson Adams

    By Jefferson Adams •

    Latiglutenase Enzyme Seems to Improve Symptoms for Seropositive Celiac Patients on a Gluten‐Free Diet

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    Reviewed and edited by a celiac disease expert.

    Celiac patients who have symptoms even on a gluten-free diet may see improvement with latiglutenase enzyme treatment.

    Latiglutenase Enzyme Seems to Improve Symptoms for Seropositive Celiac Patients on a Gluten‐Free Diet - Image: CC BY-SA 2.0--pburka
    Caption: Image: CC BY-SA 2.0--pburka

    Celiac.com 12/24/2019 - Celiac disease is a common autoimmune disease triggered by dietary gluten that can lead to severe gastrointestinal symptoms. The only current treatment is a lifelong gluten‐free diet, but many patients continue to have chronic symptoms. Could enzyme therapy help these people?

    A team of researchers recently set out to assess the effectiveness of the oral enzyme latiglutenase, for improving multiple gluten‐induced symptoms and patient quality of life (QOL) due to accidental gluten consumption by celiac patients on a gluten‐free diet.


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    The researcher team included Jack A. Syage, Peter H.R. Green, Chaitan Khosla, Daniel C. Adelman, Jennifer A. Sealey‐Voyksner, and Joseph A. Murray. They are variously affiliated with ImmunogenX, Newport Beach, CA, USA; Celiac Disease Center, Columbia University, New York, NY, USA; Stanford University, Stanford, CA, USA; Aimmune Therapeutics, Brisbane, CA, USA; and the Division of Gastroenterology and Hepatology, Mayo Clinic

    For the study, 398 symptomatic celiac patients received doses of either latiglutenase or placebo for 90 days, and responded to a daily symptom diary, along with multiple QOL questionnaires at weeks 0, 6 and 12 of the treatment periods as secondary endpoints. The results were organized according to patient antibody levels. The reults showed a statistically significant and dose‐dependent improvement in seropositive, but not seronegative, celiac patients.

    In subjects receiving 900 mg latiglutenase, improvements (P‐values) in the severity of these symptoms for week 12 were 58% (0.038), 44% (0.023), 21% (0.164) and 104% (0.049) respectively, compared with those receiving a placebo.

    Overall, the greater the symptoms, the greater the relief seen in symptomatic patients. Similar results were seen in QOL reports.

    Although the results do not show a clear benefit of latiglutenase in seropositive celiac patients across the board, they do seem to show an improvement in the severity and frequency of symptoms, including abdominal pain, bloating, tiredness and constipation, and in QOL for such patients taking latiglutenase with meals.

    Targeted enzymes, such as latiglutenase could play a role in improving symptoms and quality of life in celiac patients with ongoing sensitivity and symptoms, even while following a gluten-free diet. Going forward, look for more study, and more investigation into the value of targeted enzymes in treating celiac disease.

    Read more at the International Journal of Gastroenterology and Hepatology

    Funding disclosures for the study: Clinical trial NCT01917630 was sponsored by Alvine Pharmaceuticals; all data from this trial is presently owned by ImmunogenX. The data analysis reported here was supported in part by a grant from the National Institutes of Health (R01 DK063158 to CK). 

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  • 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.

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    GliadinX is a dietary supplement with the highest concentration of AN-PEP, Prolyl Endopeptidase (Aspergillus Niger), the most effective enzyme proven to break down gluten in the stomach. This high potency enzyme formulation is specifically designed to break down gliadin, and unlike other enzyme formulas that claim to do the same, there is a growing body of research that backs up the effectiveness of GliadinX (see Sources below).
    GliadinX does not prevent and is not a cure for celiac disease, however, extensive scientific research has been conducted at multiple medical centers which has shown that it effectively breaks down gliadin into small, harmless fragments before it can reach the small intestine. GliadinX is perfect for celiacs who still want to eat outside of their home, and not have to worry about cross-contamination, and for those who are gluten sensitive and wish to continue eating gluten.
    The quote below was made by Dr. Stefano Guandalini, Department of Pediatrics, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago Celiac Disease Center-Comer Children’s Hospital, Chicago, IL, and was published in Nutrients 2018, 10(6), 755:
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    the only one that is currently on the market is the gluten-specific enzyme, GliadinX (AN-PEP). Unfortunately, it is only capable of detoxifying 0.2 g of gluten or roughly that of 1/8 of a slice of gluten-containing bread. For this reason, it should only be used as an adjunct to the GFD when there are concerns for accidental gluten contamination and in an effort to ameliorate symptoms, not as a replacement for the GFD."
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    Sources: Scientific publications on AN-PEP enzymes:
    Extra-Intestinal Manifestation of Celiac Disease in Children. Nutrients 2018, 10(6), 755; doi:10.3390/nu10060755 Efficient degradation of gluten by a prolyl endoprotease in a gastrointestinal model Enzymatic gluten detoxification: the proof of the pudding is in the eating! Highly efficient gluten degradation with a newly identified prolyl endoprotease: implications for celiac disease Degradation of gluten in wheat bran and bread drink by means of a proline-specific peptidase
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    Celiac.com 09/25/2017 - There are currently several efforts underway to develop successful commercial enzyme treatments for celiac disease. Efforts include looking at the digestive enzymes in plants, such as the papaya and star fruits, including such predatory plants, such as the pitcher plant.
    One focus has been on developing enzymes that can break down gluten before it can trigger an immune reaction. This could prove helpful to many people with celiac disease.
    One such enzyme under development is Latiglutenase, formerly known as ALV003. Latiglutenase is a new name for an enzyme therapy designed to be taken with meals.
    The idea is that a person with celiac disease would take an enzyme tablet with a meal. If the meal had mild gluten contamination, the enzyme’s two recombinant proteins would break gluten into fragments that are not toxic to the immune system, thereby preventing exposure, and symptoms.
    But the stomach is a notoriously difficult environment to work in, so what seems like a simple idea quite a challenge from a science and biology perspective.
    Seeking to explore the ability of Latiglutinase to improve symptoms, a team of researchers recently set out to test latiglutenase on celiac patients who are seropositive despite following a gluten-free diet.
    The research team included Jack A. Syage, Joseph A. Murray, Peter H. R. Green and Chaitan Khosla. They are variously affiliated with the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester USA, the Celiac Disease Center at Columbia University, New York, USA, the Departments of Chemical Engineering and Chemistry, Stanford University, USA, and with ImmunogenX, Newport Beach, USA.
    "Though the ALV003-1221 trial was inconclusive regarding histologic improvement from latiglutenase, the evidence for symptom benefit, which is more quickly achieved, is quite convincing and clinically relevant," Joseph Murray, MD, of the Mayo Clinic in Rochester, Minn., said in a press release.
    In these trials, patients with celiac disease who were seropositive despite following a gluten-free diet saw major improvement in symptoms when taking latiglutenase with meals, according to a post hoc analysis of the CeliAction study.
    The team was really hoping to see histological improvement, but they feel satisfied that this trial shows, says Dr. Murray, that a "therapy to help patients struggling with symptoms due to celiac disease is now within reach."
    Stay tuned for more on efforts to develop effective enzyme treatments for celiac disease.
    Read more: Dig Dis Sci. 2017 Doi:10.1007/s10620-017-4687-7.
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    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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    Celiac.com 12/14/2017 - Can enzyme supplements help people with gluten sensitivity, including those with celiac disease? An Australian company is touting the results of a recent randomized, double blind study that supports enzyme supplements might be helpful for celiac patients in certain circumstances.
    The enzyme supplement was designed for people with celiac disease to use when facing likely or possible exposure to gluten, such as when traveling or eating food prepared outside their direct control. The company is careful to state that "enzyme supplementation won't cure celiac disease, and sufferers still need to avoid gluten." But the evidence from the two most recent studies does suggest that the product does help digest dietary gluten and could make life much easier for many people with celiac disease.
    The product, called GluteGuard, is based on a papaya fruit enzyme called caricain. This enzyme is shown to be helpful for celiac patients. A 2015 study showed adding caricain to bread dough reduced gluten toxicity to gluten by 90% for celiac patients.
    GluteGuard was recently evaluated in two clinical studies in Poland. The first study looked at 20 patients with celiac disease who were in clinical remission on a gluten-free diet. In that study, all patients ate one gram of gluten, equal to about one slice of bread, each day for 42 days, with 14 patients also taking GluteGuard and six taking a placebo tablet. Patients noted their symptoms and well-being each day, and received biopsies both before and after the study. Thirteen of the 14 celiac patients (93%) taking GluteGuard showed no adverse changes in clinical symptoms, biopsy results or well-being throughout the 42 day trial. Only one GluteGuard patient withdrew due to celiac-associated symptoms, while 4 of 6 taking placebo withdrew after 14 days due to adverse celiac symptoms.
    The second Polish study looked at the effectiveness of GluteGuard in patients with dermatitis herpetiformis, a gluten-triggered skin condition common in celiac patients. As with the first study, all patients in these study were in clinical remission. Patients consumed around six grams of gluten daily for seven days, with ten patients also receiving GluteGuard tablets and ten getting a placebo.
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    So, yes, enzyme supplements may provide some help for people with celiac disease, especially as a hedge against minor or occasional gluten ingestion. So far though, they are not a magic bullet, and cannot replace a gluten-free diet.
    Read more at Medicalexpress.com.

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