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 Copyright©2008 PR Newswire. All rights reserved | |
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