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Alba Therapeutics Announces the Presentation of Results of a Phase IIa Clinical Trial for Larazotide Acetate for the Treatment of Celiac Disease at the Digestive Disease Week Conference
Date:5/21/2008

ith gluten or gluten placebo during a 14 day period. Four doses of the oral formulation of larazotide acetate, all less than 10 mg, were given prior to each gluten challenge. Study endpoints included intestinal permeability (IP), measured as lactulose-mannitol ratio (LAMA), as well as patient signs and symptoms and outcomes, measured by the Gastrointestinal Symptoms Rating Scale (GSRS; validated in several gastrointestinal diseases) and the Psychological General Well-Being Index (PGWBI).

Clinical Findings:

* In the primary study outcome, the prevention of increase in LAMA ratio

from Day 0 to Day 14, the treatment groups showed a dose dependent

protection from increase in intestinal permeability as measured by LAMA

ratio versus placebo, however the difference was not statistically

significant

* In the highest dose active treatment groups of 4 and 8 mg, the LAMA

ratio did not increase after gluten exposure when compared with placebo

* Post-hoc analysis of change in LAMA ratio from Day 7 to Day 21 showed

dose dependent prevention of increase in LAMA across the 4 and 8 mg

treatment groups

* Changes in PGWBI scores and anti-tTG titers were not significant over

the time course of this study

* An unexpected enrollment effect resulted in a fall in intestinal

permeability from Day 0 to Day 7 across all groups suggesting the need

for a run-in period

* Larazotide acetate conferred protection from gastrointestinal symptoms

as measured by the GSRS as well as from expected signs and symptoms of

gluten toxicity

* Follow-up studies of longer duration are currently ongoing

Safety:

* There was no difference in rate of adverse events between Placebo and

Active Drug Groups (46% vs. 55%)

* No Serious Adverse Events (SAEs) were reported

* Headache was the most common AE (reported by
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SOURCE Alba Therapeutics Corporation
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