Going completely gluten-free is socially restrictive, expensive and time-consuming. Yet the diet is the only treatment out there for people with celiac disease, an autoimmune condition that damages the lining of the small intestines when triggered by gluten.
What's more, gluten-free eating might not be totally effective. It turns out that even celiacs who are very strict with their diet can still significantly injure their small intestines simply from incidental gluten contamination. Gluten lurks in a lot of unexpected foods, and even explicitly labeled gluten-free foods could still be contaminated, mislabeled or just plain misleading.
With this in mind, a new pill may work to reduce incidental damage and complement a special diet. The ALV003, as it is known, is made up of two gluten-specific enzymes that break down gluten into safe-to-digest fragments that don't trigger an immune response in celiacs.
The pill isn't yet on the market, but the results of a proof-of-concept study were promising: The pill successfully protected the small intestine better than a placebo in research published recently in Gastroenterology, the official journal of the American Gastroenterological Association. The study was funded by the company that makes the ALV003, Alvine Pharmaceuticals, Inc.
As part of the study, researchers randomized 41 people in Finland with medically diagnosed celiac disease to take either ALV003 or a placebo pill every day. They also asked all the participants to eat a daily "gluten challenge": two grams of gluten (in the form of breadcrumbs) for six weeks, the equivalent amount of gluten in half a slice of bread. Then the researchers took samples of small intestine and analyzed both before and after the experiment. Lead researcher and author Daniel Adelman found that the participants who took the placebo pill had significantly more intestinal injury and inflammation than those who took ALV003.
For those who took ALV003 daily, their post-experiment small intestine biopsies were virtually "indistinguishable" from the baseline biopsies researchers had taken before the trial.
"The treated patients were indistinguishable from baseline after six weeks, which means the drug appeared to protect against gluten-induced mucosal injury and intestinal inflammation," said Adelman, who is also the Chief Medical Officer of Alvine Pharmaceuticals, Inc.
But don't think that just because ALV003 can make gluten safer, celiacs can suddenly start scarfing cookies and pastries whenever they want.
"This drug is not intended to allow you to go have a pizza or French bread," said Adelman. "It's not intended to replace the gluten-free diet -- just allow it to be more effective, we hope."
"There's a compelling unmet medical need in this disease for the development of a non-dietary treatment for celiac disease, and that's what we're trying to do," Adelman added.
Adelman is currently in the middle of an international, randomized and controlled trial of 500 participants to see if the pill can actually help heal small intestine damage caused by celiac disease, but the drug is still years away from the marketplace. If all goes well with subsequent studies and U.S. Food and Drug Administration approval, expect to see the pill in stores around 2018.
Of course, other pharmaceutical companies are racing toward the same finish line as well. Alba Therapeutics Corporation, for instance, is also in the midst of trials for a drug to reduce the symptoms of celiac disease. Called Larazotide acetate, the pill prevents gluten uptake by closing the spaces between cells, making the intestines less permeable and thus less susceptible to gluten-trigged inflammation, according to Medscape.
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