18 Sep 2012

The Author

Sheryl Goldstein
Sheryl is the founder of The No Gluten Solution: Feeding Family and Friends, which is the culmination of her talents, skills, and her personal desire to develop an effortless style of cooking good food, making her guests comfortable, and always having an excuse for a dinner party.

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Will ALV-003 Be The Magic ...

Great news for all of us with celiac disease-the FDA has just given Alvine Pharmaceuticals approval for a Fast Track phase 2 trial of their potential celiac drug ALV-003.  It is the first mid-stage celiac disease study ever conducted.

“We are very pleased that the FDA has granted ALV-003 this Fast Track designation.  The decision reflects the seriousness of celiac disease and the potential of ALV-003 to address the unmet medical needs of celiac patients.  Currently there are no approved therapeutic treatment options available to patients and their physicians, “said Abhay Joshi, Ph.D., Alvine’s President and Chief Executive Officer.

In the first trial, participants, who had been following a gluten-free diet for at least a year, were split into two groups: one was given the drug, the other a placebo.  They all were given a measured amount of breadcrumbs to add to their diets. The results showed that those taking the placebo exhibited gastrointestinal symptoms.  But what was most promising was that follow-up biopsies taken from all the participants showed that there was reduced small intestine injury in those on the drug as compared to the placebo.

My first reaction to hearing that a drug was being tested for celiac was, what could a drug add if it we still needed to follow a gluten-free diet?  Shouldn’t eliminating gluten be enough? What I learned was that experts tell us that up to 60% of adult celiac patients continue to have symptoms even after eliminating gluten.  How humbled I felt knowing that I have been mostly symptom free since eliminating gluten.

So, the hope is that when this drug is used in conjunction with a gluten-free diet, it will degrade the residual gluten and reduce the likelihood of “leaky gut” syndrome.  Think of it like the medications for lactose intolerance now on the market…take it along with your food and prevent the negative medical side affects.

Let’s hope this next study is as promising as hoped.  It would be a gift, whether or not it is covered by insurance, to all of us celiacs

 

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