New Drug Shows Promise in Clinical Trials

Posted by In Just 10 Pages, Dekker, Conrad on 12-05-2011        Rating: rating rating rating rating rating

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  Researchers all over globe are leaving no stone unturned in hopes of finding a drug that would help people suffering from celiac disease and gluten intolerance. It seems there is drug that is generating some buzz in the gluten-free community. This drug, manufactured by Alvine Pharmaceuticals is called ALV003, has shown promising effects and has helped people suffering from gluten intolerance symptoms.

Celiac disease is an autoimmune disorder that affects the small intestine making it incapable of absorbing nutrients from the food. Poor absorption of nutrients leads to malabsorption syndrome and triggers variety of other related symptoms. So far, Celiac Disease has just one remedy - a gluten free diet. Eliminating gluten from the diet has helped gluten intolerance sufferers to a great extent. A gluten-free diet can help heal the small intestine and make it capable of absorbing nutrients. There is no medication other than the one recently introduced to help eliminate the symptoms of Celiac Disease. However, more testing needs to be done to fully prove its effectiveness.

Alvine Pharmaceuticals which is known for manufacturing biopharmaceuticals for autoimmune disorders such as Celiac Disease has made a breakthrough and has been able to achieve success in reducing the adverse effects of gluten intolerance. This drug has been successful in reducing the mucosal injury caused due to villous atrophy. 

“These results are groundbreaking.” - Professor Markku Maeki, M.D. and gluten intolerance specialist

A control group study was conducted to help determine the efficiency of this new drug. The active drug group had 34 patients suffering from Celiac Disease and a placebo group was also kept as the control group. Both the active group and placebo group were given 2 grams of gluten on a daily basis for a period of 6 weeks. Triumph Dining reported that “The group with the placebo reported higher incidence of ‘non serious adverse effects’ (code for GI symptoms). They also had significantly more mucosal injury in their small intestines, as measured by biopsy data”.



Lets us understand the working mechanism of this drug ALV003. ALV003 works by breaking down the gluten molecule into various non toxic parts (To obtain more information in this regard you can visit their website, AlvinePharma.com). ALV003 appears to help lesson the gastrointestinal symptoms of celiac disease and gluten intolerance.

Even when the patients try to maintain a strict gluten free diet, small amounts of gluten are usually still consumed, usually due to mislabeling or cross contamination of products Due to this, 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 commented that, “New non dietary treatment options that can either eliminate, or meaningfully reduce the gluten present in an attempted gluten-free diet are needed.”

ALV003 appears to help lesson the gastrointestinal symptoms of celiac disease and gluten intolerance

To date, gluten intolerance and Celiac Disease have no drug options to help them get relief from the devastating and debilitating symptoms. According to Professor Maeki, “These results are groundbreaking.” This is so because this wonder drug has the properties to alleviate gluten-induced injury in patients suffering from  the disease.

Triumph Dining believes these results of drug ALV003 are promising, however, this drug will need more research. ALV003 will undergo further trials - Phase 2b . Upon completion the results will be sent to the FDA for final approval. If the results of this drug continue to be successful, the millions suffering from Celiac Disease and gluten intolerance will soon get relief from the symptoms.



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