Celiac.com 11/30/2011 - Researchers have been talking about it for some time, raising the
hopes of the celiac community: a drug to help relieve us from the
harmful effects of gluten exposure. Celiac patients are closer than ever
to having such a drug on the market, as Alvine Pharmaceuticals has
announced that their drug ALV003 has shown promise in a clinical trial
by reducing gluten-triggered harm in people with celiac disease.
Celiac disease is an autoimmune reaction triggered by exposure to
gluten, a protein found in wheat, barley, and rye, that causes the
immune system to attack the small intestine, interfering with the
absorption of nutrients and leading to malnutrition and a variety of
other symptoms. The disease currently has only one treatment, which is
non-drug: the gluten-free diet. By eliminating gluten completely from
the diet, most celiac patients can heal their small intestine. There is
currently no other drug on the market that can help relieve the symptoms
of celiac disease or the intestinal damage it can cause.
Alvine Pharmaceuticals, which is focused on developing
biopharmaceuticals for autoimmune inflammatory diseases such as celiac
disease, has reported favorable results for a trial with their drug
ALV003, which was developed to lessen mucosal injury in the intestine
caused by gluten exposure in well-controlled celiac patients.
control group study was conducted that collected data from 34 celiac
patients. After both the active drug group and placebo group ingested
two grams of gluten on a daily basis for six weeks, "The group with the
placebo reported higher incidence of 'non-serious adverse events' (code
for GI symptoms)," Triumph Dining reported. "They also had significantly
more mucosal injury in their small intestines, as measured by biopsy
ALV003 works by breaking down the gluten molecule into
nontoxic parts. (Alvine Pharmaceuticals explains more specifically how
the drug works on their website, AlvinePharma.com.) The drug is intended
to help alleviate the gastrointestinal and other symptoms associated
with cross-contamination, incorrect or misleading "gluten-free"
labeling, and exposure to gluten caused by carelessness or imprudence.
Even when celiac patients take care to maintain a strict gluten-free,
it's difficult to stay completely away from gluten. That's why,
according to coordinating investigator of the latest ALV003, Markku
Maeki, M.D., chair and professor of pediatrics at the University of
Tampere and Tampere University Hospital in Finland, "New non-dietary
treatment options that can either eliminate, or meaningfully reduce the
gluten present in an attempted gluten-free diet are needed."
celiacs have no drug options to help alleviate their symptoms. "These
results are groundbreaking," said Professor Maeki, "as they demonstrate
for the first time, in a controlled clinical trial, that a drug has the
potential to diminish gluten-induced injury in celiac disease patients."
According to Triumph Dining, "After Phase 3 trials, so long as
results remain promising, ALV003 will enter Phase 2b trials soon; after
that come Phase 3 trials and (hopefully) submission to the FDA for
approval." The release of ALV003, should results remain favorable, will
no doubt bring relief to many members of the celiac community.