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What is Celiac Disease?

Celiac disease is a chronic autoimmune disease that occurs in genetically susceptable individuals when exposed to an environmental trigger, gluten.  The prevalence of celiac disease in the United States and most parts of the world, has been estimated to be approximately 1%-2% of the population.  Once considered a rare syndrome of childhood, celiac disease is now recognized as a common condition that may be diagnosed at any age and affects many organ systems.  In people who have the genetic susceptibility for celiac disease, symptoms can be triggered by ingesting proteins called glutens, which are found in grains such as wheat, barley and rye.  In patients with celiac disease, eating gluten causes a systemic autoimmune response, inflammation, and damage to the lining of the small intestine, which can result in inadequate absorption of nutrients and a wide range of clinical symptoms, including:

  • Digestive symptoms: stomach pain, bloating and/or gas, diarrhea and/or constipation pale, foul-smelling, or fatty stool
  • Symptoms of the skin/teeth:
    • a very itchy skin rash with blisters called dermatitis herpetiformis (DH)
    • pale sores inside the mouth, called aphthous ulcers
    • hair loss
    • tooth discoloration or loss of enamel
  • General symptoms/conditions
    • weight loss/weight gain
    • elevated liver enzyme levels
    • fatigue
    • anemia
    • behavior changes, irritability is one of the most common symptoms in children
    • slowed growth in children/failure to thrive in infants
    • bone or joint pain
    • osteoporosis
    • missed menstrual periods, infertility, recurrent miscarriage
    • tingling, numbness in the legs (from nerve damage)
    • muscle cramps
    • migraine headaches
    • seizures
    • brain fog

For all patients, celiac disease is a lifelong disease. Unless gluten is completely eliminated from their diet, patients have an enhanced risk for the development of further complications, such as osteoporosis, infertility, cancer, other autoimmune diseases, and increased mortality.

Currently, there are no drugs available for the treatment of celiac disease.  Current standard of care recommends that patients follow a strict, gluten-free diet; however, total exclusion of dietary gluten is very difficult because gluten is one of the most common food ingredients.  Even highly motivated patients who attempt to adhere to the diet are affected due to inadvertent or background exposure to gluten, and a majority of patients with celiac disease who are in clinical remission and who claim to be following a gluten-free diet have persistent abnormalities in small bowel biopsy specimens and persistance of symptoms.  Inadvertent exposure to gluten has been identified as the leading cause of non-responsive celiac disease among clinically diagnosed patients who were presumed to be on a gluten-free diet.  Thus, there is an acute need for non-dietary therapies for celiac disease.  One approach involves the use of proteases that digest gluten in the stomach.

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Alvine Pharmaceuticals, Inc.
75 Shoreway Rd., Suite B
San Carlos, CA 94070
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Business Inquiries

Kirk Essenmacher, M.D., M.B.A.
T: (650) 596-2434
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