THE WOODLANDS, Texas, July 28, 2011 /PRNewswire/ — Lexicon Pharmaceuticals, Inc.
(Nasdaq:
LXRX), a biopharmaceutical company focused on discovering
breakthrough treatments for human disease, announced today that it
has successfully completed a Phase 1 clinical trial of LX1033, an
orally-delivered small molecule drug candidate for
diarrhea-predominant
irritable bowel syndrome (IBS-d). Lexicon plans to move
LX1033 forward into a Phase 2 study in patients with IBS-d.
Top-line results demonstrated that LX1033 was well tolerated at
all doses and produced a statistically significant reduction in
serotonin synthesis compared to placebo, as measured by both plasma
(p<0.001) and urinary (p<0.01) 5-hydroxyindoleacetic acid
(5-HIAA), a biomarker for serotonin synthesis. Importantly, a
greater reduction in serotonin synthesis was achieved with lower
and less frequent dosing and at lower drug exposure levels than was
observed with Lexicon’s first generation serotonin synthesis
inhibitor, LX1031, which had previously demonstrated clinical
benefit to IBS patients in a Phase 2a clinical trial as measured by
both global assessment of adequate relief and stool
consistency.
“Based on the completed LX1033 Phase 1 program, we are confident
that a convenient dose regimen of this compound can provide the
level of serotonin reduction that we have previously associated
with clinical benefit for patients with IBS-d,” said Dr. Brian
Zambrowicz, chief scientific officer at Lexicon. “We were
also impressed by the performance of the blood test for measuring
5-HIAA and anticipate using this biomarker to guide future drug
development of LX1033.”
The LX1033 Phase 1 trial was conducted as a
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