Alba Therapeutics Presents New Data for Larazotide Acetate at the 2008 American College of Gastroenterology Annual Scientif...(efficacy in inflammatory boweldisease ta...),Health

About the Studies

Results from CLIN 1001-004 were presented at ACG in a poster entitled "Larazotide Acetate Prevents Immunologic Changes Induced by Gluten Challenge in Celiac Disease Patients" (Poster 446). The randomized, double-blind, placebo-controlled study was designed to evaluate the effects of larazotide acetate on the systemic immunologic changes induced by a two week gluten challenge in patients with celiac disease. Study results showed that larazotide acetate was well tolerated and showed signs of efficacy in preventing immunologic changes induced by gluten challenge in patients with celiac disease, consistent with the beneficial effects observed on intestinal permeability, signs and symptoms. Clinical findings included:

-- Gluten challenge in the placebo (control) group resulted in an increase in circulating regulatory T cells (CD4, CD25, FOX-P3+) and a decrease in B cells (CD3, CD19+). These changes were completely prevented in the group on larazotide acetate.

-- There was a small, not statistically significant increase in the anti-tTG titer in the placebo (control) group, which was prevented in the group on larazotide acetate.

-- Other trends in specific monocyte populations induced by gluten challenge were also prevented to varying extents by larazotide acetate.

The second presentation, "Larazotide Acetate, a Tight Junction Inhibitor Peptide, Inhibits Epithelial Permeability Induced by TNF-alpha and IL-4" (Poster 1052) included results from a study investigating the effect of larazotide acetate on tumor necrosis factor (TNF-alpha) and interleukin (IL-4) induced permeability. The study showed that larazotide acetate inhibited increased permeability mediated with TNF-alpha and IL-4, which suggests the potential of larazotide acetate as a therapeutic agent for
'/>"/>