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 These options are still years from commercial availability, but
early results have been encouraging, according to a review of the
drug pipeline in Gastroenterology Report.
“Based on data on ClinicalTrials.gov, there are two investigational
products we are aware of which may enter large confirmatory trials
in the not too distant future,” said lead author Dr. Klaus Gottlieb,
senior medical director of the immunology and internal medicine
department for Quintiles, a company that provides bio-pharmaceutical
development services and consulting in Durham, North Carolina.
“One of them is an enzyme that splits the molecule in wheat that
causes celiac disease, gluten, into smaller harmless products and
another one promises to make the gut less leaky and thus prevent
potentially toxic substances (from) reaching deeper layers where
they may cause inflammation,” Gottlieb said.
Two million Americans and 3.5 million Europeans have celiac disease,
although more than half in the U.S. are not diagnosed, the authors
say. People with the disorder must avoid eating gluten, a protein in
wheat, rye and barley. If people with celiac disease consume foods
that contain those grains, their immune response leads to intestinal
damage, malnutrition and other problems.
Several new therapies have shown promise in human trials, appearing
at least somewhat effective. None have yet entered safety trials,
the final step before Food and Drug Administration approval and
commercial availability.
It’s still hard to say when one of these options will reach the
market, but if all goes well it could happen in three to five years,
Gottlieb told Reuters Health by email.
For one potential oral therapy, patients take a mixture of two
enzymes that split the gluten molecule into smaller harmless
products. In a trial of adults with celiac disease, those taking
this drug had no change in their intestinal biopsies after eating
gluten, while those taking a placebo did have evidence of injury to
the intestinal lining.
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However, symptoms were similar in both groups.
Three daily doses of another drug, designed to control an
inflammatory process in the intestines, did appear to reduce
diarrhea, indigestion and abdominal pain symptoms in one trial.
Several others in earlier stages of development are aimed at
suppressing the immune response to gluten and preventing intestinal
inflammation.
Before the drugs are approved, it’s hard to say if they will allow
people with celiac disease to eat gluten in small amounts, large
amounts, or without restriction, Gottlieb said.
“If they eat a lot of gluten, they may still have some symptoms and
perhaps other long-term health consequences,” he said. Some may be
best to take right before eating gluten and others might be more
effective when taken on a regular schedule.
SOURCE: http://bit.ly/1Gohfll
Gastroenterology Report, online February 26, 2015.
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