Alba Therapeutics Corporation has enrolled and randomized its first patient in an eight-week phase IIb trial with oral larazotide acetate, an inhibitor of intestinal barrier dysfunction, for the treatment of patients with active celiac disease (CD). The global multi-centre, randomized, double-blind, placebocontrolled study will evaluate the clinical and histological efficacy, safety and tolerability of larazotide acetate in 106 active CD subjects adhering to a gluten-free diet, while also testing components of a celiac disease activity rating index, a new patient reported outcomes instrument.
"This is Alba's sixth human trial with larazotide acetate and highlights our efforts to improve the treatment of celiac disease and help the celiac community by raising the awareness of this important and neglected disease" stated Dr Francisco Leon, Head of Clinical Research and Development at Alba. "Alba is committed to studying new treatment options for patients with celiac disease. By conducting this important pioneering clinical study we believe we can learn more about celiac disease and provide insights for physicians and celiac patients," stated Bruce Peacock, CEO of Alba.
Celiac disease is a lifelong T-cell mediated auto-immune disorder, which occurs in individuals who are genetically susceptible and is characterized by small intestinal inflammation, injury and intolerance to gluten. CD is a growing public health concern, affecting approximately 3 million people in the United States and over 6.5 million people worldwide. People with CD cannot tolerate gluten proteins and have an inflammatory response to the gluten in wheat, barley and rye. This results in varying symptoms such as fatigue, skin rash, anaemia, fertility issues, joint pain, weight loss, pale sores inside the mouth, tooth discoloration or loss of enamel, depression, chronic diarrhoea or constipation, gas and abdominal pain. The immunology and nutritional abnormalities in celiac disease can potentially result in long-term complications such as osteoporosis, refractory sprue, small intestinal cancer, and lymphoma. The only current treatment for CD is complete elimination of gluten from the diet, which results in remission for most patients, but can be very difficult to implement in practice. "However, the response to the gluten-free diet is poor in up to 30 per cent of patients and dietary nonadherence is the chief cause of persistent or recurrent symptoms