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Glutenase ALV003 Protects Celiacs Against Gut Damage from Gluten

Celiac.com 06/02/2014 - Despite following a gluten-free diet, many people with celiac disease continue to have symptoms, and to suffer from ongoing small intestinal inflammation. Can a drug be created to alleviate such symptoms and inflammation, and protect celiacs on a gluten-free diet against small amounts of gluten contamination?

Photo: Wikimedia Commons--amitchel125San Carlos California-based Alvine Pharmaceuticals is conducting a phase 2 trial to determine whether their drug, ALV003, an orally administered mixture of 2 recombinant gluten-specific proteases can protect celiac disease patients from gluten-induced mucosal damage. For this trial, Alvine is working with researchers Marja-Leena Lähdeaho, Katri Kaukinen, Kaija Laurila, Pekka Vuotikka, Olli-Pekka Koivurova, Tiina Kärjä-Lahdensuu, Annette Marcantonio, Daniel C. Adelman, and Markku Mäki.

They are affiliated with the School of Medicine and Tampere University Hospital at the University of Tampere; the Department of Gastroenterology and Alimentary Tract Surgery at Tampere University Hospital and School of Medicine at the University of Tampere, and FinnMedi Oy in Tampere, Finland; the Department of Medicine at Seinäjoki Central Hospital in Seinäjoki, Finland; Liikuntaklinikka, Oulu Diakonissalaitos; and Terveys, Oulu Diakonissalaitos, Oulu, Finland.

For their Phase 2 trial, the research team first established two grams of gluten per day as the optimal challenge dose for their 6-week gluten study. They then randomly assigned 20 adults with biopsy-proven celiac disease to receive ALV003, and twenty-one to receive a placebo. Both groups also received 2 grams of gluten each day. The team conducted duodenal biopsies at baseline, and after gluten challenge, focusing on the ratio of villus height to crypt depth and densities of intraepithelial lymphocytes.

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A total of seven patients dropped out due to adverse reactions. Four were receiving ALV003, and three were receiving the placebo. Sixteen patients given ALV003 and 18 given placebo were eligible for efficacy evaluation. Biopsies from subjects in the placebo group showed evidence of mucosal injury after gluten challenge, with average villus height to crypt depth ratio changed from 2.8 before challenge to 2.0 afterward. (P = .0007; density of CD3þ intraepithelial lymphocytes changed from 61 to 91 cells/mm after challenge; P = .0003).

However, the team saw no significant mucosal deterioration in biopsies from the ALV003 group. The two groups showed no significant differences in symptoms, though they did show substantial differences in morphologic changes, and CD3þ intraepithelial lymphocyte counts differed significantly from baseline to week 6 (P = .0133 and P = .0123, respectively). This small, but important, step means that ALV003 did provide significant protection against gluten-induced gut damage for people with celiac disease on an otherwise gluten-free diet, which means that Alvine can continue to the next phases in the development process.

If successful, glutenase ALV003 will be the first drug to protect people with celiac disease against gut damage from small amounts of gluten.

Source:

  • Clinicaltrial.gov, Numbers: NCT00959114 and NCT0125569

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1 Response:

 
Lee
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said this on
10 Jun 2014 5:01:57 PM PDT
Interesting article. I have celiac disease. Hoping for more help than a GF diet.




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Me too. I had numerous chest x rays as I couldnt shake colds off and they always progressed on to my chest. Barely happens since my diet change

You make a good point i'll be sure to watch out. My mom is coming with me shes not gluten free I'll have her try the stuff that may be contaminated and tell me how it is :b hahah

I have been thinking that I need to change my diet and this article has only confirmed it. I eat quite a lot of gluten-free 'treats' at the moment, cakes, chocolate etc. I rationalise by the fact I dont drink or smoke and have a restricted choice so I 'deserve' a break, but I guess my choices are leading in a bad direction. Maybe I'll have a go at making some better choices...

Love reading this story as it is rare (I think) to find someone else with the swallowing issues! Hate that this is your experience however! My daughter also has the swallowing issues and it got so severe (we had no idea about Celiac) that she had to do intensive therapy to learn how to swallow again. It got better but never resolved. Once she went gluten-free it got way better though a recent exposure to oats caused it to flare up again. Do you mind me asking - Has your swallowing issues 100% resolved being gluten-free? Does it ever actually go away and stay away or will it always pop up from time to time?

I will say what everyone else says and get tested again with the endoscope and biopsy to confirm, you will need to be on gluten for 12 weeks for blood test 2 weeks for endoscope at least a slice of bead a day. The thing about celiac is many symptoms can be quite minor, hell even before I had my MAJOR symptoms show I had some of the other issues show up in my every day life and I just thought it was normal. Regardless if you keep eating gluten with celiac disease it will slowly eat away at your body internally til it does become a problem. Celiac is a autoimmune disease that reacts to the gluten proteins, and has misdirected attacks on your own body internally by mistake trying to kill the gluten. Now the damage can lead to all kinds of other auto immune diseases, random allergies, food intolerance, and even cancer. I suggest if you do have it, stay on the gluten-free diet, your just basically changing brands there are many gluten-free food versions of everything now days. Be thankful you got this early, I developed issues with dairy, corn, peanuts, and a whole list of others along with another autoimmune disease Ulcerative Colitis that makes it so I can not eat sugars or carbs or my intestines swell. Getting on a gluten-free diet before your damage progresses will not only keep you healthier for longer, and let you live a pretty normal life but also save you from this pain and very limited diet if the damage progresses too much. As to your fatigue, you changed over to gluten-free diet, you stopped eating a bunch of the Fortified foods, and depending on the route you took of either whole foods ore more processed foods. You could be eating to many empty carbs, starches, and not enough nutrients. OR if you took the whole foods approach you be lacking in your daily calorie intake or not the right ratio of nutrients. You might have to supplement a few of them.