How Close Are New Celiac Disease Treatments?

Celiac.com 04/10/2015 - Of course, a strict gluten free diet is still the only safe and effective treatment for celiac disease. However, new drugs in development, some of which are currently being tested on humans, might allow people with celiac disease to safely eat gluten again, at least in small amounts.

To be fair, even if all goes smoothly, it will be a few years at least before we see such treatments on the market. Moreover, even though many early results have been encouraging, none have yet entered safety trials, the final step before Food and Drug Administration approval and commercial availability.

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Drugs currently under trial include an enzyme that splits the protein in wheat that triggers adverse reactions, into smaller harmless products, and another which promises to make the gut less leaky, and thus block potentially toxic substances from triggering inflammation.

There are several other drugs in earlier stages of development aimed at suppressing the immune response to gluten and preventing intestinal inflammation:

• ALV003, which will protect people with celiac disease against gut damage from small amounts of gluten.
• BL-7010 is a novel co-polymer for the treatment of celiac disease, which significantly reduces the immune response triggered by gluten.
• ImmusanT’s therapeutic vaccine Nexvax2 combines three proprietary peptides that elicit an immune response in celiac disease patients who carry the immune recognition gene HLA-DQ2.
• Larazotide acetate (AT-1001) is Alba Therapeutics Corporation’s investigational product, a first-in-class tight junction regulator, intended for the treatment of patients with celiac disease.
• AVX176, from Avaxia Biologics, is an investigational oral antibody drug that is the subject of U.S. composition of matter patent 8,071,101, “Antibody Therapy for Treatment of Diseases Associated with Gluten Intolerance.” The patent, which expires on May 27 2029, provides broad coverage for treating celiac disease using orally administered antibodies produced by Avaxia’s proprietary platform technology [32].
• ActoGenX is carrying out discovery research in celiac disease with its range of ActoBiotics™, which use Lactococcus lactis as an expression system to locally secrete bio-therapeutics such as cytokines, antibodies, hormones, etc.
• Chemocentryx’s CCR9, is also known as Traficet-EN, or CCX282B), and was originally intended for patients with moderate-to-severe Crohn’s disease. It has completed one Phase 2 trial in 67 patients with celiac disease.

Meanwhile, in Europe, Dr. Falk Pharma and Zedira recently announced the start of phase I clinical trials for the drug candidate ZED1227, a direct acting inhibitor of tissue transglutaminase. The small molecule targets the dysregulated transglutaminase within the small intestine in order to dampen the immune response to gluten which drives the disease process.

Some of these drugs may be taken right before eating gluten, while others might be more effective when taken on a regular schedule. If approved for use as intended, these drugs will likely allow people with celiac disease to eat gluten in small amounts. To my knowledge, there is no drug in current trial phases that is designed to permit unrestricted gluten consumption.

So, the good news is that the next few years may see commercially available treatments that might actual help people manage celiac disease. The downside for people with celiac disease, at least for now, is that there is no treatment on the horizon that will allow safe, unlimited gluten-consumption. Moreover, there is no hint that a cure is coming anytime soon.

Still, it’s good to know that researchers are working on providing helpful tools for treating celiac disease.

Are you looking forward to seeing new treatment options for celiac disease? What kind of benefits should such treatments offer?

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