Celiac Disease Drugs in Development
Potential Celiac Disease Treatments May Be Available in a Few Years
Right now, the only available treatment for celiac disease is the gluten-free diet. But that may be changing. In a few years, it's possible that people diagnosed with celiac disease will have the option of one or more celiac disease drugs to treat their condition.
At least four different drug developers are vying to have the first
approved product to treat celiac disease. The drugs in development take
different approaches: One is an enzyme designed to break down the gluten
protein, one is a vaccine to help desensitize you to gluten, the third
is a medication intended to help prevent leaky gut, and the fourth
actually binds to the gluten molecule in an effort to escort it safely
from your body.
It's not clear which of these four will win out. But there's a good
possibility that at least one of them will be approved by the end of
this decade ... if not much sooner.
Here's a rundown of the three main celiac disease drugs in development:
• Alvine Pharmaceuticals' ALV003. Alvine
has progressed farthest in its quest to bring to market a drug for
celiac disease, and ALV003 has received Fast Track designation from the
U.S. Food and Drug Administration, meaning it could be approved more
quickly. Its approach involves a potent digestive enzyme that can help
break down gluten before your immune system reacts to it. Phase IIa trials of ALV003 as a celiac disease treatment
showed promise, and the company said in hopes to begin its Phase IIb
trials late in 2012. However, ALV003 will not allow you to eat unlimited
amounts of gluten; at best, it's expected only to protect against gluten cross-contamination in foods.
• ImmusanT's Nexvax2. ImmusanT
is pursuing a vaccine approach to celiac disease treatment. ImmusanT is
holding Phase 1 trials in Australia, New Zealand and the U.S. to see if
Nexvax2 is safe and potentially effective at larger doses. The drug is
designed to induce renewed immune system tolerance to gluten. That
theoretically would allow people with celiac to consume gluten products
again. Nexvax2 is genetically tailored to work with people who carry
particular celiac disease genes
— specifically, the DQ2 gene, present in up to 90% of everyone with
celiac disease. It wouldn't work if you don't have DQ2, although
ImmusanT plans development of vaccines that would work with other gene
combinations.
• Alba Therapeutics Corp.'s AT-1001. Once a promising potential celiac disease drug, AT-1001 suffered setbacks
when it failed to produce good results in an early clinical trial.
Pharmaceutical giant Shire Pharmaceuticals pulled out of a deal with Alba Therapeutics
on the drug in 2009. However, Cephalon Inc., another major drug
manufacturer, acquired the rights to AT-1001 in early 2011, pending
results of more trials, which are underway. AT-1001 is designed to
induce your body to close the junctions between the cells in your
intestines, thereby reducing or eliminating the problem of "leaky gut,"
which may start an inflammatory cascade. However, AT-1001 likely won't
prove to be a panacea for celiac disease, either — at best, it's
expected to protect you against small amounts of gluten.
• BioLineRx's BL-7010. This drug, which currently is in
pre-clinical trials, has been shown in mice to reduce the immune system
response that leads to intestinal damage and villous atrophy in celiac
disease. BL-7010 actually binds to the gluten protein, which seems to
decrease the
protein's toxicity. Then the drug — with the gluten molecule attached —
passes through the digestive system and is expelled from the body in
stool. BL-7010 hasn't been tested in humans so far, although researchers
performed lab experiments with biopsy specimens from diagnosed celiacs
and found the drug may help to calm immune system reactions specific to
celiac disease. BioLineRx needs to perform more trials to show that
BL-7010 is safe before it can move on to clinical trials to see whether
the drug actually works. Still, like the other potential drugs, the
company believes that at best BL-7010 will just protect against
cross-contamination; it won't allow you to eat large amounts of gluten.
Again, it's not clear which of these celiac disease drugs — if any —
will make it to market. But if and when one does, I expect diagnosis and
treatment of celiac disease to skyrocket, as both consumers and
physicians become far more aware of the condition.
By Jane Anderson, About.com Guide
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