Celiac Disease Drugs in Development

Celiac disease treatments may hit the market by 2017

There may soon be a pill to treat celiac disease. Credit: Getty Images/Blend Images

Right now, the only available treatment for celiac disease is the gluten-free diet. But that may be changing. By 2017 or 2018, it's possible that people diagnosed with celiac disease will have the option of one or more celiac disease drugs to treat their condition.

At least four different drug developers are vying to have the first approved product to treat celiac disease. The drugs in development take different approaches: One is an enzyme designed to break down the gluten protein, one is a vaccine to help desensitize you to gluten, the third is a medication intended to help prevent leaky gut, and the fourth actually binds to the gluten molecule in an effort to escort it safely from your body.

It's not clear which of these four will win out. But there's a good possibility that at least one of them will be approved by the end of this decade ... if not much sooner.

Celiac Disease Drugs in Development

Here's a rundown of the three main celiac disease drugs in development:

Alvine Pharmaceuticals' ALV003/Innovate Biopharmaceuticals Inc.'s INN-202. This drug may be the first drug approved to treat celiac disease. It has received Fast Track designation from the U.S. Food and Drug Administration, meaning it could be approved more quickly. This drug approach involves a potent digestive enzyme that can help break down gluten before your immune system reacts to it. Trials of the drug have shown some promise, and in early 2016 Alvine licensed the drug to Innovate Biopharmaceuticals Inc., which renamed it INN-202. Innovate expects to move to phase 3 drug trials (in theory, the last step before approval) in late 2016.

However, INN-202 will not allow you to eat unlimited amounts of gluten; at best, it's expected only to protect against gluten cross-contamination in foods.

Alba Therapeutics Corp.'s AT-1001. This drug, which also holds FDA Fast Track designation, is catching up with ALV003 and could beat it to market.

 AT-1001 suffered setbacks when it failed to produce good results in an early clinical trial, and pharmaceutical giant Shire Pharmaceuticals pulled out of a deal with Alba Therapeutics on the drug in 2009. However, Cephalon Inc., another major drug manufacturer, acquired the rights to AT-1001 in early 2011, pending results of more trials. Those trials have produced positive results, and as of February 2014 Alba announced it would move on to Phase 3 trials, the last phase before approval. AT-1001 is designed to induce your body to close the junctions between the cells in your intestines, thereby reducing or eliminating the problem of "leaky gut," which may start an inflammatory cascade. However, AT-1001 likely won't prove to be a panacea for celiac disease, either — at best, it's expected to protect you against small amounts of gluten, like ALV003.

ImmusanT's Nexvax2. ImmusanT is pursuing a vaccine approach to celiac disease treatment. ImmusanT is holding Phase 1 trials in Australia, New Zealand and the U.S. to see if Nexvax2 is safe and potentially effective at larger doses. The drug is designed to induce renewed immune system tolerance to gluten. That theoretically would allow people with celiac to consume gluten products again.

Nexvax2 is genetically tailored to work with people who carry particular celiac disease genes — specifically, the DQ2 gene, present in up to 90% of everyone with celiac disease. It wouldn't work if you don't have DQ2, although ImmusanT plans development of vaccines that would work with other gene combinations.

BioLineRx's BL-7010. This drug has been shown in mice to reduce the immune system response that leads to intestinal damage and villous atrophy in celiac disease. BL-7010 actually binds to the gluten protein, which seems to decrease the protein's toxicity. Then the drug — with the gluten molecule attached — passes through the digestive system and is expelled from the body in stool.

BL-7010 has undergone safety testing in humans and was found to be well tolerated. According to BioLineRx, testing began in 2015 to see if the drug works as expected to diminish gluten's effects on the body. Previously, researchers performed lab experiments with biopsy specimens from diagnosed celiacs and found the drug may help to calm immune system reactions specific to celiac disease. Still, like the other potential drugs, the company believes that at best BL-7010 will just protect against cross-contamination; it won't allow you to eat large amounts of gluten.

Again, it's not clear which of these celiac disease drugs — if any — will make it to market. But if and when one does, diagnosis and treatment of celiac disease likely will skyrocket, as both consumers and physicians become far more aware of the condition.

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