Larazotide – Hope for Celiacs

New Research Gives Hope for Celiacs

It is always encouraging to see the new research trying to find cures for Celiac disease.  Here is some new research that may unlock some keys and give new hope to Celiacs

“Alba Therapeutics Corporation presented results from two clinical studies this week at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting. Data from study CLIN 1001-004, the first Phase IIa trial conducted in celiac disease and the first to assess the prevention of immunologic changes in celiac disease, showed that larazotide acetate (AT-1001) successfully demonstrated prevention of gluten-induced immunologic changes in celiac patients.

Results from the study showed that larazotide acetate is the first pharmacologic agent to prevent changes in blood mononuclear cell populations (specifically T-reg cells and B Cells) and other markers of immunological change associated with active celiac disease. This data suggests that larazotide acetate offers potential as a future treatment of celiac disease. Results from a second poster presented at ACG showed that larazotide acetate also inhibited the effect of inflammatory cytokines, including tumor necrosis factor (TNF-alpha) and interleukin (IL-4) on intestinal epithelial permeability, in vitro, further suggesting that the product offers potential as a future treatment for inflammatory bowel disease (IBD).

Larazotide Acetate is a novel, non-absorbed peptide currently being studied in Phase IIb trials for the treatment of celiac disease. Larazotide acetate has the potential to become the first approved medicine to treat celiac disease and has been granted “Fast Track” designation from the U.S. Food and Drug Administration (FDA) for this indication.

Celiac disease affects approximately one percent of individuals in the United States and Europe, or approximately 6.5 million individuals. The only accepted management for the disease is a strict gluten-free diet; however, the response to therapy is poor or incomplete in up to 30 percent of patients. These facts suggest that there is a need for therapeutic modalities beyond dietary modification.

Related data presented in a third poster at ACG include results from a qualitative study conducted to investigate the validity of the Gastrointestinal Symptom Rating Scale (GSRS) in patients with celiac disease. The GSRS is a validated measure used in clinical trials for irritable bowel syndrome and peptic ulcer disease. GSRS has been utilized in studies to assess larazotide acetate, including CLIN 1001-004 and CLIN 1001-006. Results from the poster presentation suggest that certain subscales of the GSRS may have relevance for use in establishing the efficacy of novel treatments for celiac disease. This is the first time the validity of the GSRS clinical scale has been studied in celiac disease to assess efficacy of treatments.”

Source Medical News Today

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