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 drug 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.

The most promising candidates in the drug pipeline include the following.

INN-202 (Larazotide Acetate)

Innovate Pharmaceutical's INN-202 (larazotide acetate) is a drug that uses a potent digestive enzyme that 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 INN-202. Phase III clinical trials are currently underway. Results of the trial may be available sometime in mid- to late-2021

BL-7010

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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  1. U.S. National Library of Medicine. Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms. Updated October 30, 2019.

  2. U.S. National Library of Medicine. Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.