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Company Testing Drug That Protects Celiac Sufferers Against Gluten Contamination

Celiac.com 03/11/2013 - People with celiac disease must follow a gluten-free diet if they want to remain healthy, but a 200-patient study conducted by Alvine Pharmaceuticals show that 90 percent of celiac patients who followed a gluten-free diet still reported symptoms of the disease.

Photo: CC--winnifredxoxoThat reality is helping to drive an effort by Alvine to develop a drug that would help those people to avoid symptoms and damage that come with accidental exposure to gluten.

According to a recent press release, Alvine had already raised at least $42 million for its celiac disease drug, and now has $6 million more as it works through a second phase 2 trial.

The company's top drug prospect is ALV003, a mix of two recombinant gluten-specific proteases that’s designed to be used along with a gluten-free diet to prevent immune reactions associated with celiac disease.

As disclosed in a recently filed U.S. Securities and Exchange Commission document, the company has raised at least $6 million in debt and other non-equity securities, and could raise up to $500K more.

ALV003 is designed to be taken orally by people with celiac disease at the time of a meal. It mixes with and breaks down the gluten in food before it can reach the small intestine, where it would cause inflammatory responses.

The drug is designed to prevent accidental gluten contamination, not to allow celiac sufferers to freely and safely consume large amounts of gluten.

In a phase 2a study, ALV003 met its goals and reduced gluten-induced intestinal injury in celiac patients who were already following a gluten-free diet. According to clinicaltrial.gov, ALV003 is presently in a study phase with a March 2013 completion date.

In the fall of 2012, Alvine received permission from the U.S. Food and Drug Administration to fast-track ALV003, which means the company can work more closely with the FDA during clinical trials, and may get a faster review if they file a New Drug Application.

Alvine is a San Carlos, California-based biopharmaceutical company founded in 2006 on technology from Stanford University. Its investors include Abbott Biotech Ventures, Panorama Capital, InterWest Partners, Prospect Venture Partners, Sofinnova Ventures, Black River Asset Management and Flagship Ventures.

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16 Responses:

 
Gluten Free Foodies
Rating: ratingfullratingemptyratingemptyratingemptyratingempty Unrated
said this on
11 Mar 2013 2:38:47 PM PST
Oh dear. We need to get away from the idea of popping a pill to solve our problems. Big pharma is only interested in profits, not health.

 
Sue
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said this on
13 Mar 2013 3:42:08 PM PST
I don't like the idea of pill popping any more than the next person, but I find the cross contamination issue in our food chain to be an insurmountable obstacle in trying to be gluten-free. My main celiac symptom is a rash that is very sensitive to gluten. In spite of eating a very clean diet and almost never eating out, I have a few small blisters almost all the time. I find that eating things like nuts or quinoa (or anything really) can cause a break out, even though the packaging doesn't declare a shared equipment situation. I would bet that most people are getting more gluten than they realize and just don't have the sensitive detection system I have. (I call it my canary in the mine.) If there were a pill that could clean up the small amounts of gluten in food, it would certainly make my life easier and maybe help those that believe they are eating gluten-free but still have unexplained symptoms.

 
SueN
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said this on
18 Mar 2013 9:48:33 AM PST
I agree with you. Despite being very careful, including keeping my home gluten-free, with lab tests and endoscopy that have normalized on a gluten-free diet, I still often have symptoms. My son also has celiac disease, and since I am so sensitive to tiny bits of cross-contamination, I jokingly say that I can test foods out for him and tell him if they're safe (or not).

 
Ursula
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said this on
19 Mar 2013 1:43:12 PM PST
Hi Sue, I have celiac disease and found out that the thyroid medicine that I take every day has a trace of gluten. So does my foundation, mascara, shampoo, face cream, hair dye, etc.!!! None of the companies can state that any of their products are gluten-free... It's a real pain in the X#*! I too get the rash on my face. Best wishes!

 
Vanessa
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said this on
14 Mar 2013 2:48:43 PM PST
Please, no more promoting of drugs. I can't stand it.

 
dappy
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said this on
18 Mar 2013 7:26:13 AM PST
This claim has been around for years - I remember going to a seminar back when I was diagnosed in 2007. Never seems to actually go anywhere though.

 
Penny
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said this on
18 Mar 2013 9:42:10 AM PST
Pharmaceuticals definitely make the world a better place, the problem is how they are marketed and abused by people. I am celiac and have been gluten-free for a few years now, but it's almost impossible to avoid accidental glutening and cross-contamination, even though I have drastically altered my life. I, for one, would welcome something that would help me from accidental gluten ingestion. Then I could actually occasionally go out to dinner, etc. without it being such a stress-filled game of Russian roulette. If we don't encourage companies to do research, it will never happen.

 
Gill
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said this on
19 Mar 2013 7:18:21 AM PST
I'm in agreement with Sue and Penny, and although I refuse to take some medications, this pill would make life so much easier, though of course it depends what the ingredients and possible side effects are. It also depends on the price. I am also lactose intolerant, and I love cheese and there is a pill to take to reduce lactose on consumption but it is so ridiculously expensive here in Spain.

 
AnnaH
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said this on
18 Mar 2013 11:21:17 AM PST
I agree with Sue. There is lots of cross contamination in most foods. I take digestive enzymes and probiotics with almost every meal. It really helps. If this pill (proteaze enzymes) can help digest the minute amounts of gluten that we inadvertently, accidentally eat, I am all for it. The article states that it is not so Celiac people will be able to eat large amounts of gluten. It is about time for this to happen!

 
larry mac

said this on
18 Mar 2013 11:32:34 AM PST
I doubt if the naysayers here would tell their doctor "no thanks, I don't need antibiotics for this infection", "no treatment for my breast cancer thank you", "my child's ear infection will clear up on its own". If you don't like "popping pills," good for you. But thank God there are greedy researchers out there trying to help those that need and want treatments to help their suffering.

 
maverita
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said this on
18 Mar 2013 11:33:55 AM PST
My symptoms continued until I eliminated xanthum gum from my diet in addition to being gluten-free, and my gut permeability finally improved. I am pretty healthy these days and thankful that someone alerted me to the potential problem with xanthum gum, which they seem to put in ALL the gluten-free products these days. I even found it in pineapple juice and moisturizers. Doctors remain ignorant about the allergenic effects of xanthum gum.

 
SueN
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said this on
18 Mar 2013 1:09:50 PM PST
Why are you suggesting that doctors are "ignorant"? If you have found a cause for your symptoms, that is good. For most people with celiac disease, xantham gum is considered to be permitted.

 
Julie
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said this on
18 Mar 2013 8:17:57 PM PST
I'm all for it as well. If a person doesn't want to take them, more power to you. Don't take them. But for people who want to see if something can improve their symptoms and quality of life - they should have the right to try it.

I also take probiotics every day and digestive enzymes with every meal. I don't know how I would get by without them. I was a sickly human being before I discovered those, and I discovered them 20 years before I got a diagnosis of celiac disease. Those pills kept me alive and relatively healthy.

 
Ladybug
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said this on
18 Mar 2013 9:46:22 PM PST
Apparently I am in the minority, but just like people take medicine for type 1 diabetes, I would take medicine for celiac disease.
I would be happy to take pill - medicine or probiotic - so I could safely eat a meal out. I would also happily take medicine so I could eat a piece of my children's birthday cake with them. If you don't want to take pills, awesome, don't. If you don't want to read about medicine being developed for celiac disease, don't.
I am happy to read about advances, research, and possible medication to keep my auto immune disease from hurting me!

 
Chris

said this on
19 Mar 2013 5:02:33 AM PST
@Sue: Be very wary. Many nut and seed packagers 'dust' their products with wheat flour to prevent sticking and clumping. They seldom if ever report this on the label because they don't consider the flour to be a 'product.' About the only way to test for this at the moment is to discover by trial and error which brands cause problems.

@SueN: There is a big difference between ignorant and stupid. There are very few stupid doctors. Ignorance on the other hand is 'not having sufficient information.' Any doctor who graduated before 1995 will not have learned anything about celiac disease other than the name in class. If they haven't read about recent discoveries in medical journals, they may in fact be ignorant of celiac disease facts.

 
SueN
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said this on
19 Mar 2013 3:24:51 PM PST
First, the word "ignorant" has negative connotations. Whether or not the writer of the comment intended this, I do not know. But we should all be careful how we talk about groups of people, including doctors.
Second, if doctors counted only on their in-class learning to treat patients, we would all be in big trouble. Doctors share information with each other, read medical journals, attend lectures and conferences, and are required to adhere to CME (continuing medical education) requirements in order to maintain licensure.
Third, yes, of course, some doctors are going to know more about celiac disease than other doctors. The standard of care with regard to this disease, and many others, is changing, in terms of including it in the differential diagnosis when a patient presents with symptoms. So, more and more, doctors are thinking about celiac disease. Many of us have had delays in diagnosis of celiac disease and other conditions. And many of us have struggled to figure out what foods impact us negatively. But this is generally not because of "ignorance" on the part of doctors.




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