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New Drug Shows Promise in Celiac Disease Clinical Trials

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.

Photo: CC--SLU Madrid CampusNow 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.

A 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 data."

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."

Currently 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.

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11 Responses:

 
nancy morrison
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
05 Dec 2011 10:53:15 AM PST
I'm all for helping celiacs. It is a real challenge to stay completely gluten free.

 
dennis
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said this on
05 Dec 2011 4:15:02 PM PST
I am very glad to hear the news of a possible breakthrough for some help for us countless people with celiac disease.

 
Barb
Rating: ratingfullratingfullratingfullratingemptyratingempty Unrated
said this on
05 Dec 2011 7:09:15 PM PST
I don't trust drug companies. What are the side effects?

 
Robert
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said this on
06 Dec 2011 4:44:31 PM PST
Side effects? Really?
You might not get sick with an accidental exposure outside of your normal strict Coeliac diet!

I for one would really welcome a safety net option...

 
Rebecca Lockhart
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said this on
05 Dec 2011 8:12:04 PM PST
I am very glad to see the research resulting in new treatments. Like many others, maintaining that GF diet, along with my diabetes diet feels truly overwhelming at times.

 
Suzanne
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said this on
06 Dec 2011 3:17:13 AM PST
That sounds great - not because I want to eat gluten, but just to alleviate the symptoms from accidentally ingesting it, especially when eating out or traveling.

 
Tiffany
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said this on
09 Dec 2011 2:33:42 AM PST
I am enthused to see there is research being done to potentially treat celiac disease. Although I am holistic and prefer not to take prescription medications (unless needed), I believe if there are many holistic approaches to treating celiac. Naturepath doctors' would be a great group of people to consult with regarding AV003. Furthermore, humans were never suppose to eat foods containing gluten. People that suffer with celiac are the mutants because their bodies reject the toxins found in gluten. I've suffered with celiac for 16 years and I was finally diagnosed after suffering for 14 years. Good luck to all my fellow celiac friends. Cheers, AV003.

 
Leah
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said this on
10 Sep 2013 12:15:50 PM PST
Actually, I was on a clinical trial in OKC for many months. I was one who actually received the blocker. It works with no side affects. While on the trial I had several endoscopic procedures with no trauma signs. I was very thankful to have been apart of the study and for not receiving the placebo blocker.

 
Mathew
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said this on
08 Jul 2014 10:23:20 AM PST
It would be AWESOME to have a huge slice of thick crust pizza, a piece of my wife's apple pie or a great burger.
get it done already!!!

 
andy schnatz
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said this on
10 Sep 2014 2:05:42 AM PST
Figaroe has gluten free pizza crust and it is VERY good.

 
andy schnatz
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
10 Sep 2014 1:59:20 AM PST
Great info-- I have celiac and my life is hell.




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