THE WOODLANDS, Texas,
Dec. 3, 2013 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced top-line
results from an initial Phase 2 study exploring the use of LX1033
in diarrhea-predominant irritable bowel syndrome (IBS-d). LX1033 is
an investigational drug that inhibits serotonin synthesis in the
gastrointestinal tract. Serotonin is a neurotransmitter that has
been shown to play a role in the symptoms of irritable bowel
syndrome.
The primary endpoint of this study was the change in stool
consistency averaged from baseline to day 28. All treatment groups,
including placebo, showed significant improvements over time, yet
differences between placebo and LX1033 in stool consistency were
not statistically significant. Further analyses of the stool
consistency data were performed adjusting for early terminations
which may have enhanced the placebo response rate. These additional
analyses of stool consistency yielded favorable results for the
LX1033 500mg three times daily dose group compared to placebo, and
some of these findings were associated with statistically
significant results (p<0.05). LX1033 reduced the production of
plasma 5-HIAA (a biomarker for serotonin synthesis) significantly
more than placebo, with the greatest reductions observed in the 500
mg three times daily dose group. This same LX1033 dose also
produced the greatest reduction in abdominal pain, an important
measure of efficacy in IBS-d. The proportion of patients showing an
abdominal pain intensity weekly response (defined as a reduction in
abdominal pain of at least 30% from baseline for at least 50% of
the weeks assessed, with no worsening from baseline in stool
consistency) was 33% on placebo and 47% on LX1033 500 mg given
three times daily (p<0.05). LX1033 was safe and well tolerated
in the study, with adverse events evenly distributed among LX1033
treatment arms and placebo.
"While LX1033 showed similar improvements in stool consistency
as compared to the placebo patients who completed the study, there
were positive effects on abdominal pain in the treated group that
warrant further study," said Pablo
Lapuerta, M.D., Lexicon's chief medical officer. "While this
initial Phase 2a study was underway, we completed long-term
toxicology studies which would allow us to conduct a Phase 2b study
at doses informed by the current results and with a duration of 12
weeks, a treatment period that has historically been important to
identify clinically meaningful changes as compared to placebo."
In this Phase 2 study of IBS-d, 373 patients were randomized to
be treated for 28 days with either placebo or one of three
different dose levels of LX1033 for 28 days, 1000 mg twice daily,
500 mg twice daily, and 500 mg three times daily. The primary
endpoint was the change from baseline in stool consistency as
evaluated by the Bristol Stool Form Scale. A key secondary endpoint
was the change from baseline in abdominal pain, and other endpoints
included the change in plasma 5-HIAA.
About Lexicon
Lexicon is a biopharmaceutical company
focused on discovering breakthrough treatments for human
disease. Lexicon currently has multiple programs in clinical
development for diabetes, irritable bowel syndrome, carcinoid
syndrome and other indications, all of which were discovered by
Lexicon's research team. Lexicon has used its proprietary
gene knockout technology to identify more than 100 promising drug
targets. Lexicon has focused drug discovery efforts on these
biologically-validated targets to create its extensive pipeline of
clinical and preclinical programs. For additional information
about Lexicon and its programs, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains
"forward-looking statements," including statements
relating to Lexicon's clinical development of LX1033,
characterizations of the results of and projected timing of
clinical trials of LX1033, and the potential therapeutic and
commercial potential of LX1033. The press release also
contains forward-looking statements relating to Lexicon's growth
and future operating results, discovery and development of
products, strategic alliances and intellectual property, as well as
other matters that are not historical facts or information.
All forward-looking statements are based on management's current
assumptions and expectations and involve risks, uncertainties and
other important factors, specifically including those relating to
Lexicon's ability to successfully conduct clinical development of
LX1033 and preclinical and clinical development of its other
potential drug candidates, advance additional candidates into
preclinical and clinical development, obtain necessary regulatory
approvals, achieve its operational objectives, obtain patent
protection for its discoveries and establish strategic alliances,
as well as additional factors relating to manufacturing,
intellectual property rights, and the therapeutic or commercial
value of its drug candidates, that may cause Lexicon's actual
results to be materially different from any future results
expressed or implied by such forward-looking statements.
Information identifying such important factors is contained under
"Risk Factors" in Lexicon's annual report on Form 10-K for the year
ended December 31, 2012, as filed
with the Securities and Exchange Commission. Lexicon
undertakes no obligation to update or revise any such
forward-looking statements, whether as a result of new information,
future events or otherwise.
SOURCE Lexicon Pharmaceuticals, Inc.