Gluten Enzyme Solutions for Celiac Disease

Gluten Enzyme Solutions for Celiac Disease

Gluten Enzyme Solutions for Celiac Disease

Gluten Enzyme was the winning solution in the 2011 iGEM competition, earning the first prize for a U.S. team. He first studied the enzyme for his postdoctoral research at Seattle’s Institute for Protein Design. He is Chief Scientific Officer of PvP Biologics, a biotechnology company based in San Diego. He studied the enzyme’s effects on gluten by passing a tube into people’s stomachs and nosGluten Enzyme Solutions for Celiac Diseasees.



AN-PEP, or a novel type of gluten enzyme, has recently been approved for use in the U.S., where it is available as a supplement. It has been shown to degrade gluten in healthy subjects regardless of the gastric emptying rate. Despite the new approval, whether AN-PEP is safe for celiac disease patients is not clear. Nevertheless, the results are encouraging for people with non-celiac gluten intolerance.

While AN-PEP has been approved to treat and prevent celiac disease in animals, humans have yet to be tested on its effectiveness. A recent study conducted in the World Journal of Gastroenterology found that it had positive results in healthy subjects. The enzyme is available in the United States under Tolerance’s brand name and is produced by the Dutch firm DSM. Dr. Fasano, director of the Center for Celiac Research and Treatment, is the only doctor who has approved the enzyme for this condition.

The enzyme Konig studied is called AN-PEP, and it prevents a large amount of gluten from entering the small intestine. Although it cannot wholly destroy gluten in real life, its clinical effect can be seen by the reduced excretion of gluten in humans. AN-PEP is a supplement to be taken as a diet supplement or an aid to gluten-free cooking. The results were presented at the Digestive Disease Week conference in 2017.

AN-PEP is effective in degrading gluten when consumed in low doses. Its maximal activity was achieved at a pH of 4 to 5. It does not degrade pepsin but remains fully functional in the stomach. The enzyme explicitly degrades gluten epitopes and leaves behind residues of proline. The enzyme was recently used in a crossover study in which 12 healthy volunteers were given a low or high-calorie liquid meal that contained four grams of gluten.


The ASP gluten enzyme is a microbial protein that hydrolyzes gluten-related dietary proteins. However, its ability to break down gluten is lacking in its specificity for immunotoxic peptides. Despite this, ASP may still be useful for gluten detoxification. ASP can break down short gluten peptides that serve as substrates for other, more specific enzymes. For this reason, clinical trials evaluating ASP in the treatment of celiac disease are necessary.

Essential Enzymes | 05 Important Tips

The specific activity of ASP has been determined by using aspergillopepsin digestion of an immunogenic peptide from a2-gliadin. A concentration of approximately 20 mg/mL was used for each digestion. The ratio of enzyme to the substrate was 50:1. The pH was 4.5. After the digestion, a protein concentration was measured by LC/MS/MS. Cleavage sites are indicated with arrows.

Dietary gluten exclusion is incomplete, and patients suffer from nutrient and mineral malabsorption. Inadvertent gluten exposure can lead to osteoporosis and anemia. The ASP is a food enzyme product based on the existing over-the-counter products. It is believed that the enzymes in this product can detoxify up to one gram of gluten while it is in the stomach. This may be a significant benefit for patients prone to celiac disease.

ASP gluten enzyme is effective for digestion of gluten in clinical trials. This enzyme was discovered as a byproduct of the production of microbial plaques in the mouth. The enzyme can hydrolyze gluten-derived proline-rich peptides in the teeth. However, it has not been entirely determined yet. If you consider using an ASP gluten enzyme, make sure it is a clinically proven ingredient.


The DPP-IV gluten enzyme is a proprietary formula designed to support the digestive system and promote Dipeptidyl peptidase-IV, responsible for digesting gluten protein fragments. The DPP-IV gluten enzyme is a targeted wellness solution that addresses the potential ramifications of unintentional gluten exposure and supports the intestinal barrier. Its high concentrations of DPP-IV, which are highly active in the small intestine, provide significant support for various health conditions.

Previous in vitro studies have demonstrated that the efficacy of the AN-PEP gluten enzyme is dose-dependent. Although posthoc analyses of the study did not show a difference between the placebo and high-dose AN-PEP groups, the lower dose of the enzyme likely was the most effective in reducing gluten concentrations. This could also be because the low-dose enzyme had an optimal enzyme-to-gluten ratio.

DPP-IV works in the small intestine to degrade gluten. In healthy subjects, the enzyme efficiently degrades gluten. This means that the enzyme is not a part of the immune system, and there are few side effects from taking it. A person with celiac disease should consider taking it to prevent adverse reactions. The DPP-IV enzyme has been studied extensively, but it is still in its infancy.

Gluten-intolerant people may feel nervous or anxious when eating out in restaurants. Gluten-free products can help ease this fear by helping to ensure that they avoid contamination from other foods. When accompanied by a gluten-free diet, the DPP-IV enzyme can help people cope with gluten-related symptoms. While the enzyme isn’t a cure-all, it can help people who have accidentally glutened themselves or have been affected by cross-contamination.


The research on EP-B2 shows that it can effectively detoxify gluten before it reaches the organs affected by Celiac sprue. This enzyme is delivered as a proenzyme that rapidly self-activates once in the stomach acid. It is a potent protease, converting intact gluten proteins into smaller oligopeptides. This method also reduces the incidence of gluten-related Celiac sprue.

One study used both SC PEP and EP-B2 to investigate the synergistic effects of EP-B2 and SC PEP in detoxifying gluten. SC PEP and EP-B2 are known to enhance gluten detoxification capacity in combination. In addition to EP-B2, SC PEP and EP-B2 complement their substrate specificity. Increasing SC PEP doses did not improve EP-B2-mediated gluten detoxification capacity.

The invention further provides methods for lowering toxic levels of gluten oligopeptides in food. These methods include a combination enzyme product comprising glutamine-specific endoprotease from barley and prolyl endopeptidase from Sphingomonas capsulata. When used in conjunction with the aforementioned methods, the enzyme product degrades gluten into non-toxic amino acids.

Oral proteases have been approved for prophylactic therapy in high-risk groups. These groups include Type I diabetics, family members of celiac patients, HLA-DQ2 positive individuals, and those who have gluten-associated symptoms without a formal diagnosis. The enzyme may be administered in a regular or low dose, while a temporary high dose is used in patients recovering from gluten-mediated enteropathy or with impaired gut function.

EP-B2 and SC PEP ratio in a combination drug product is typically 10:1 or 5:1. The latter is more potent than the former. In addition, SC-PEP is active over a wide pH range. Hence, it may be considered for the treatment of Celiac disease. For this reason, the ratio of EP-B2 and SC-PEP should be considered in combination.


In a recent acquisition, Takeda Pharmaceutical Company Limited is launching TAK-062 – a highly potent super glutenous aimed at treating celiac disease. Celiac disease occurs when a person’s body has gluten sensitivity, causing inflammation and damage to the small intestine. In trials, TAK-062 lowered the amount of gluten in patients’ small intestines by more than 99%.

Moreover, a comprehensive immune system responds to dietary gluten through several well-defined epitopes containing nine amino acids. When the human body recognizes these epitopes, an enzyme called tissue transglutaminase is released, converting the amino acid glutamine (Q) to a negatively charged glutamic acid (E).

PvP Biologics has already taken TAK-062 through phase 1 of the clinical trial, and Takeda has exercised its option to purchase the company. The deal is worth an undisclosed amount, and Takeda has committed to achieving certain milestones in the next few years. Takeda is gearing up for a full clinical trial of the product. It announced clinical data from a three-arm study of 38 patients, indicating that the enzyme degraded up to 95% of gluten.

This research shows that AN-PEP is highly effective in degrading gluten in patients with celiac disease, and its activity ranges between pH two and eight. In addition, it is not degraded by pepsin and remains fully functional within the stomach. It explicitly targets gluten epitopes, cleaves the peptide, and leaves behind proline residues. Salden et al. tested AN-PEP and a low-calorie liquid meal containing 4 g of gluten to test this hypothesis.

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