22958 Trial Data: ALV003 Reduces Gluten Damage in Celiac Disease Patients - Celiac.com
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Trial Data: ALV003 Reduces Gluten Damage in Celiac Disease Patients

Celiac.com 07/23/2012 - At 2012 Digestive Diseases Week in San Diego, California, Alvine Pharmaceuticals, Inc. announced the publication of data from Phase 2A trial of its main celiac disease compound, ALV003.

Photo: CC--Carolina Biological SupplyThe results show that ALV003, orally administered to celiac disease patients on a gluten free diet, significantly reduces gluten-triggered intestinal mucosal damage.

For the trial, 41 adults with clinically proven celiac disease who had followed a gluten-free diet for at least one year were randomly given ALV003 or a placebo each day for six weeks. During that time, they also received 2g of gluten in the form of bread crumbs.

Participants received a small bowel biopsy prior to randomization and again, at the end of the six week challenge.

The results showed that the study met its primary endpoint of a clinically and statistically meaningful reduction in intestinal mucosal damage in celiac patients on a gluten-free diet. Damage was measured by the ratio of the villus height to crypt depth, or Vh:Cd between the ALV003 and placebo treated groups over the six week study period.

Secondary endpoints included change in intraepithelial lymphocyte (IEL) density, gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS) scores, celiac serologies, safety and tolerability.

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Each subject received small bowel biopsy at the start of the trial, and again after six weeks of daily gluten challenge.

When researchers compared biopsy results from 34 patients, they found significantly less small intestinal mucosal damage in patients treated with ALV003 than in placebo-treated patients (p=0.013).

Placebo-treated patients suffered worse damage and symptoms. Most often, these included abdominal distention, flatulence, eructation, abdominal pain and diarrhea.

The published data shows that:

  • Biopsy results for patients who received ALV003 had significantly reduced small intestinal mucosal damage compared with placebo-treated patients (p=0.0133).
  • For placebo-treated patients, IELs, including CD3+ and CD3+ aB and subsets, which measure cellular inflammation responses, were significantly higher, but were mostly normal in the ALV003-treated patients.
  • ALV003-treated patients had better overall GSRS scores and scores for indigestion and abdominal pain symptoms, compared with placebo-treated patients, though the results were not statistically significant.
  • Patients reported no serious adverse events, however, placebo-treated patients reported more regular and consistent non-serious adverse. Such events that occurred in 10 percent or more patients included abdominal distention, flatulence, eructation, diarrhea, nausea, headache and fatigue.
  • Celiac-disease blood tests revealed no significant changes between the ALV003 and placebo-treated patients, though results did show positive trends for tissue transglutaminase and deamidated gliadin peptide antibody titers in the ALV003-treated group, which indicates improved immune response.

Daniel Adelman, M.D., Alvine's Senior Vice President and Chief Medical Officer, says that the trial results represent the first time that any such treatment for celiac disease has met its pre-specified primary endpoint of providing protection against damage from gluten-exposure in celiac disease patients, with data that is both clinically and statistically significant.

Such a drug could help to protect gluten-free celiac disease patients against accidental gluten contamination.

The company plans to initiate a Phase 2B trial later this year.

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2 Responses:

 
Cynthia
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said this on
30 Jul 2012 5:49:08 PM PDT
I would have rated this article excellent had I see an estimated approval for distribution to the public, or a link to track the progress of testing. Exciting news for someone who has permanent brain damage from late diagnosis of celiac. However, I anticipate the cost beyond my financial means on disability and uninsured due to the high cost of preexisting condition.

 
An Onimous
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said this on
31 Jul 2012 9:44:00 PM PDT
I only want to know: how long until random internal organs begin to fail or malfunction as a result of yet another new mystery drug?

I'd rather starve to death than be a guinea pig for big pharma again.




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You may find these interesting, they're from Professor Marios Hadjivassiliou, a leading expert on gluten ataxia: http://www.acnr.co.uk/pdfs/volume2issue6/v2i6reviewart2.pdf Best of luck helping your daughter

Yep. The one that is most relevant I think is the post by Backtalk. Backtalk went back on gluten and have to a colostomy done on an emergency basis. Not fun. She regretted ignoring the gluten-free diet.

Welcome Lochella Hopefully you can draw some comfort from finally having an answer and thus starting the path to good health. Healing is going to come from your own body as you progress on the gluten free diet and it stops fighting itself and starts repairing that damage. You're still in the very early days and it's not an instant process sadly. 6 months is the usual figure bandied around for seeing significant improvement, although hopefully you'll get some signs of improvement much quicker than that. The single best thing you can do is to eat good simple whole foods and make sure absolutely no gluten gets into your diet. There's some tips here: With stomach pains peppermint tea is my go to drink. Avoiding caffeine seems to help as well as its rough on digestion at the best of times. This may be a time to ease up on alcohol as well and consider dropping dairy, many find they're lactose intolerant but this can correct itself in time. You will find lots of good info, advice and support here, I hope the community is of help to you as it was to me. Best of luck!

I recently got diagnosed with Celiac disease I must of had it my whole life. I'm 35 I've always had severe stomach problems, in and out of hospitals and misdiagnosed until now. My small intestine is severely damaged I'm now waiting to see a dietitian and my specialist wants to see me again in 2 weeks. How do some of you deal with the pain of the healing process and what helps you? I'm in so much pain?

I recently got diagnosed with Celiac disease I must of had it my whole life, in 35 I've always had severe stomach problems in and out of hospitals and misdiagnosed until now. My small intestine is severely damaged in now waiting to see a dietitian and my specialist wants to see me again in 2 weeks. How do some of you deal with the pain of the healing process and what helps you? I'm in so much pain?