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Celiac Disease Drugs in Development

Potential Celiac Disease Treatments May Be Available in a Few Years

Right now, the only available treatment for celiac disease is the gluten-free diet. But that may be changing. In a few years, 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.

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

• Alvine Pharmaceuticals' ALV003. Alvine has progressed farthest in its quest to bring to market a drug for celiac disease, and ALV003 has received Fast Track designation from the U.S. Food and Drug Administration, meaning it could be approved more quickly. Its approach involves a potent digestive enzyme that can help break down gluten before your immune system reacts to it. Phase IIa trials of ALV003 as a celiac disease treatment showed promise, and the company said in hopes to begin its Phase IIb trials late in 2012. However, ALV003 will not allow you to eat unlimited amounts of gluten; at best, it's expected only to protect against gluten cross-contamination in foods.

• 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.

• Alba Therapeutics Corp.'s AT-1001. Once a promising potential celiac disease drug, AT-1001 suffered setbacks when it failed to produce good results in an early clinical trial. 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, which are underway. 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.

• BioLineRx's BL-7010. This drug, which currently is in pre-clinical trials, 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 hasn't been tested in humans so far, although 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. BioLineRx needs to perform more trials to show that BL-7010 is safe before it can move on to clinical trials to see whether the drug actually works. 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, I expect diagnosis and treatment of celiac disease to skyrocket, as both consumers and physicians become far more aware of the condition.

By , About.com Guide

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