Pill Treatment for Celiac Disease

More than 2 million people in the United States have celiac disease thats about 1 in 133 people, according to the Department of Health and Human Services. And many of them are children. Celiac disease is caused by an abnormal immune response to proteins, called gluten, found in certain grains like wheat, rye and barley. Normal digestion takes place in the small intestine, which is lined with finger-like projections called villi that help enhance the absorption of nutrients. In children with celiac disease, eating gluten can destroy or damage the villi. When this occurs, the child cannot absorb the necessary vitamins and nutrients. Signs and Symptoms Celiac disease can be difficult to diagnose in children because it can mimic other intestinal disorders such as irritable bowel syndrome and lactose intolerance. Some children experience symptoms the first time they are exposed to gluten, while others develop symptoms later in life. Common symptoms are bloating, gas pain and loose, frequent stools. However, some children do not experience these symptoms and instead exhibit delayed weight gain, slow physical growth or unexplained weight loss. Rather than just impacting digestion, celiac disease can affect the entire body. There may be neurological or psychiatric conditions, infectious and/or bleeding tendencies,osteoporosis and general malnutrition. Some children develop skin rashes or are irritable or tired. Testing It is important to understand that children should continue eating foods that contain gluten while testing is being conducted.A gluten-free diet can cause the tests to be inaccurate. Blood Test:the blood is tested for high levelsof antibodies to gluten and other proteins. Intestinal Biopsy:a tissue sample is taken by passing an endoscope through the mouth and stomach, into the small intestine. Children are usually sedated with anesthesia for this procedure. Treatment The only treatment for celiac disease is the complete elimination of food and drinks containing gluten from the childs diet.

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The BL-7010-gliadin complex is eventually excreted from the digestive tract, preventing the absorption of gliadins into the blood. This significantly reduces the immune response triggered by gluten. The safety and efficacy of BL-7010 was demonstrated in pre-clinical studies. BL-7010 was invented by Prof. Jean-Christophe Leroux from the Department of Chemistry and Applied Biosciences, Institute of Pharmaceutical Sciences, ETH Zurich, in Zurich, Switzerland and is being developed by BioLineRx under a worldwide exclusive license agreement with Univalor. About Celiac Disease Celiac disease is a chronic, autoimmune, inflammatory disease of the small intestine characterized by damage to the lining of the small intestine and typically leads to dyspepsia, malabsorption and a variety of other symptoms. It occurs in genetically predisposed individuals and is caused by an immunological reaction to gluten, found in wheat, barley and rye. Estimates suggest that 1% of the world’s population is affected by celiac disease, and prevalence is expected to increase dramatically with improved diagnosis and awareness of the disease. The celiac market is projected to reach $8 billion by 2019. Today there are no pharmacological agents approved for celiac disease and the only treatment option is a life-long, strict, gluten-free diet, which is difficult to maintain both due to food contamination with gluten, as well as eating habits in a social setting. About BioLineRx BioLineRx is a publicly-traded biopharmaceutical development company dedicated to building a portfolio of products for unmet medical needs, as well as those with advantages over currently available therapies. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization. BioLineRx’s current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Ikaria Inc.

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BioLineRx to Present at 15th International Celiac Disease Symposium

Theyve kind of turned it into a super-enzyme. The idea is that people with celiac disease could take a medication containing this super-enzyme to aid in the breakdown of gluten, preventing the unpleasant symptoms experienced whenever you eat gluten-containing foods. However, making the leap from a successful computer study to a real-world trial of the enzyme could be quite a process. People often have varying biological responses to identical medications, which means the so-called celiac pill might not work for everyone. Were not all wired the same, Dr. Yepuri says. Your response to a pill could be different from my response. The study also notes that the enzyme was able to break down only 95 percent of the gluten peptide associated with celiac disease. Its still unknown whether the 5 percent that remains intact would be enough to cause digestive symptoms in people with gluten sensitivity. I dont think the quantity of gluten exposure and its translation to active, clinical disease is something thats understood well, Yepuri notes. The gold standard for [celiac] diagnosis is doing a biopsy of the small intestine at the time of an upper endoscopy. I have patients whose biopsies have proven that they have celiac disease, but they dont have digestive symptoms at all. Who knows how much gluten it would take to elicit a response? Though the development of a medication for celiac disease is an exciting prospect, it must be tested in humans before it can make its way to drugstore shelves. Extensive human studies would help to determine such things as proper dosing, pill design, and whether it should be taken with food or without. Potential side effects must also be examined. Could there be a harmful effect to taking this in large doses? Yepuri asks.

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