Promising Celiac Disease Drugs in the Pipeline

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

A number of drug manufacturers are currently conducting clinical trials to assess the safety and effectiveness of a number of novel drugs agents. Each has a different approach and mechanism of action (MOA). It is hoped that by inhibiting a process of this disorder, we may one day entirely erase celiac disease from the lexicon of autoimmune illnesses.

Among the three most promising candidates in the drug pipeline include the following.

INN-202 (Larazotide Acetate)

Innovate Pharmaceutical's INN-202 (larazotide acetate) is a drug which uses a potent digestive enzyme which appears to be able to break down gluten before your immune system can react to it. The results of phase II clinical trial were promising and demonstrated that the drug was both safe and tolerable. The drug's MOA both decreases the permeability of the intestines while tempering the movement of autoimmune antigens into the intestines.

While INN-202 may greatly reduce the symptoms of celiac disease, it is unlikely that a person will be able to eat unlimited amounts of gluten. Some dietary restriction would still be needed.

The U.S. Food and Drug Administration (FDA) has fast-tracked the drug. Phase III clinical trials are currently underway. Results of the trial may be available sometime in mid- to late-2018

Nexvax2 Vaccine

Nexvax2 is the only drug candidate which aims to immunize individuals against the disease and allow them to return to a normal diet. Nexvan2 has already successfully completed a Phase Ib safety trial and is in the process of moving to larger Phase II trials.

Nexvax2 is modeled on an emerging class of therapeutic vaccines which aims to treat people already affected by a disease. It is based on the same principles as traditional desensitization therapies used for allergies. Similar vaccine models are under investigation to treat autoimmune disorders such as multiple sclerosis, type 1 diabetes, and rheumatoid arthritis.

Nexvax2 is genetically tailored to people who have a specific gene (DQ2) present in 90 percent of people with the disease. As such, the vaccine would not work if you don't have DQ2.

Beyond this, the one main question investigators have is how long-lasting the effects of the vaccine may be. The Phase Ib trial involved repeated dosing, While those results were promising (more people were able to complete a gluten challenge than those on placebo), it remains to be seen how potent and durable the drug actually is.

No word yet on when researchers will embark on Phase II/III clinical trials.


BL-7010 offers an entirely different approach to treating celiac disease. Rather than targeting the intestines or the autoimmune response, BL-7010 binds to the gluten protein itself and inhibits its ability to be absorbed.

BL-7010 is a non-absorptive polymer which is able to conceal gluten from the enzymes that aim to break it down. By achieving this, the immune system is less able to trigger an autoimmune response. The bound gluten and drug would then be expelled from the body in the stool.

After having completed Phase I and II trials, the manufacturers took an alternate route and started promoting BL-7010 as a food supplement rather than a pharmaceutical drug. In January 2016, the company received approval for this from the European Union and is currently embarking on clinical efficacy trial under the classification of a Class IIb medical device.

A Word From Verywell

While promising, it is still unclear whether any of these drugs will make it to market. In the end, any candidate would need to fulfill three promises if they are to be considered viable. They would need to be easily administered, durable, offer reasonable dosing schedules, be well-tolerated, and, most importantly perhaps, be affordable.

So there still remains a lot to be answered. But with continued research and greater insights into the mechanisms of the disease, we may soon see a day where we no longer live gluten-free.

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  • Wingjiranirun, M.; Kelly, C.; and Leffler, D. "Current Status of Celiac Disease Drug Development." American Journal of Gastroenterology. 2016; 111(6):779-86.