drug to treat celiac disease

While the gluten-free diet effectively reduces and even eliminates symptoms of celiac disease, many people still experience distress. To that end, a number of drugs aimed at treating celiac disease are in various stages of development. But it is not known when the U.S. Food and Drug Administration (FDA) will approve them for market. Three products are furthest along in the process.

Larazotide acetate

Taken orally, larazotide acetate drug works in the gut to decrease the permeability of the intestine, one manner in which gluten causes symptoms. The medicine is not meant to allow those with celiac disease to eat gluten-containing foods. Instead, it works with the gluten-free diet to prevent “leaky gut” syndrome in cases of incidental cross-contamination.

The compound has consistently reduced symptoms in multiple clinical trials in more than 800 patients with celiac disease. It will begin testing in a large Phase 3 clinical trial in late 2016. This is the first celiac disease drug to get this far in the approval process.

IMGX-003

Formerly ALV003, this oral drug combines two protein enzymes that degrade gluten. Patients who were given this medication and then a gluten challenge showed no significant signs of intestinal mucosal injury.

Already through Phase I and Phase 2, it is the only treatment that has shown both histologic success and improvement of symptoms in clinical trials. Biopharmaceutical company ImmunogenX, which acquired IMGX-003 in March 2016, plans to take it through late-phase clinical trials.

Nexvax2

This injectable vaccine-like product changes the body’s immune response to gluten. According to ImmunosanT, the company behind Nexvax2, it is the only celiac disease treatment in clinical development today that has the potential to empower patients to return to “a normal diet, good health and improved quality of life.” After positive results in Phase I clinical trials, the next step will be Phase 2 testing, in which it will be given to larger group of people and further evaluated for safety and effectiveness.

Some experts feel taking a combination of products may be the best protection against symptoms and damage caused by exposure to gluten, but that will be evaluated once the products enter the market.

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A drug to treat celiac disease moved closer to reality with the announcement that it will be tested in a large clinical trial later this year.

Innovate Biopharmaceuticals has announced that a compound known as larazotide acetate or INN-202 will be tested in a Phase 3 clinical trial, the first time a celiac disease drug has gotten this far in the approval process.

Larazotide acetate has the potential to become the first approved medicine to treat celiac disease and has been granted “Fast Track” designation from the U.S. Food and Drug Administration (FDA).

The medicine is not intended to allow those with celiac disease to knowingly consume foods containing gluten. Instead, it works with the gluten-free diet to prevent so-called “leaky gut” syndrome in cases of incidental cross-contamination.

Larazotide acetate belongs to a class of drugs called tight junction regulators. Tight junctions, which are located in the bowel, should remain closed except to shed dead cells. However, in patients with celiac disease, the presence of gluten causes the tight junctions to remain open. This starts an inflammatory cascade within the bowel that eventually destroys the absorbing lining, called the intestinal villa.

Early research suggests larazotide acetate may help keep the tight junctions closed when taken prior to a meal, thus reducing the inflammatory process in response to gluten.

In the Phase 3 clinical trial, the drug will be given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow it to be used safely. If Phase 3 is completed successfully, Innovate can request approval from the FDA for marketing the drug.

According to the FDA, the length of the study in this phase can last anywhere from one year to four years. If the trial shows that the drug is safe and effective for its intended use, Innovate can apply for marketing approval. From that point, the FDA has six to 10 months to make a decision whether to approve the drug.

“There is a huge demand for adjunctive therapies from the celiac patient community, and I am happy to see larazotide acetate moving ahead with what will be the first Phase 3 trials ever conducted in celiac disease,” said Daniel A. Leffler, M.D., director of research at the Celiac Center at Beth Israel Deaconess Medical Center in Boston.

Alba Therapeutics, which conducted the initial research and development of the drug, previously known as AT-101, recently licensed the additional clinical testing and future distribution rights to Innovate.

Michael Savett is a frequent contributor to Gluten-Free Living. He blogs at glutenfreephilly.com.