Lexicon Announces Positive Phase 2 Results of LX1031 in Non-Constipating Irritable Bowel Syndrome
November 12 2009 - 5:07PM
PR Newswire (US)
-LX1031 demonstrates beneficial effect of new mechanism of action -
Clinical response correlates with reduction in biomarker of
serotonin synthesis - Favorable safety profile observed in patients
treated during four-week study Conference Call on November 13, 2009
at 11:00 a.m. Eastern Time THE WOODLANDS, Texas, Nov. 12
/PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc.
(NASDAQ:LXRX) announced today that the company's investigational
new drug, LX1031, a tryptophan hydroxylase (TPH) inhibitor,
demonstrated positive results in clinically important parameters
for the treatment of non-constipating irritable bowel syndrome
(IBS). Top-line results showed that treatment with one gram of
LX1031 four times daily produced a statistically significant
improvement in global assessment of relief of IBS pain and
discomfort over the four-week dosing period as compared to placebo
(p=0.0465). Improvements in global assessment parameters also
corresponded with statistically significant improvements in stool
consistency. Notably, increased clinical response correlated with a
greater reduction in serotonin synthesis as reflected by measures
of urinary 5-HIAA, a breakdown product of serotonin. "Treatment
with LX1031 reduced symptoms of IBS in this clinical trial, and
holds promise for patients with this disease," said Dr. Brian
Zambrowicz, chief scientific officer at Lexicon. "We believe the
fact that the clinical benefit was correlated to the reduction in
the 5-HIAA biomarker validates our therapeutic strategy of
inhibiting TPH as a novel treatment option for patients with IBS.
The overall safety and efficacy profile observed to date supports
further development of this novel mechanism in IBS." The Phase 2
clinical trial, which began at the end of December 2008, was a
four-week, randomized, double-blind, placebo-controlled study to
evaluate the safety and tolerability of LX1031 and its effects on
symptoms associated with IBS. The study included 155 patients with
either diarrhea-predominant IBS or mixed IBS. Two dose levels were
evaluated: a 250 mg dose and a 1,000 mg dose, each administered
four times daily (QID). LX1031 was well tolerated, with no
statistically significant differences in adverse events observed
between placebo and either treatment group. Efficacy endpoints
evaluated included a global assessment of adequate relief, as well
as measures of specific symptoms associated with IBS. Based on the
positive data obtained, Lexicon intends to pursue the development
of LX1031 as a novel treatment for patients with IBS. "We are
pleased with the outcome of this proof-of-concept trial as we
continue to advance our pipeline of drug candidates with new
mechanisms of action," said Dr. Arthur T. Sands, president and
chief executive officer of Lexicon. "These results further validate
our genetic strategy to discover breakthrough treatments for human
disease." Top-line results from this study will be presented at the
upcoming GASTRO 2009 conference in London on November 25, 2009 at
2:30 pm local time, included in the session entitled, "Therapeutic
insights in functional digestive disorders." Lexicon has three
additional drug candidates progressing through Phase 2 clinical
trials including LX1032, a peripherally-available TPH inhibitor for
carcinoid syndrome, LX2931, an S1P lyase inhibitor for rheumatoid
arthritis, and LX4211, an SGLT2 inhibitor for type 2 diabetes.
Phase 2 clinical results from these programs are expected over the
next 12 months. Lexicon Conference Call: Lexicon management will
hold a conference call to discuss the LX1031 results at 11:00 a.m.
Eastern Time on November 13, 2009. The dial-in number for the
conference call is 888-220-1244 (within the US/Canada) or
706-679-5615 (international). The conference ID for all callers is
41598440. An archived version of the call will be available on
Lexicon's corporate website at http://www.lexpharma.com/. About
LX1031 LX1031 was discovered and developed by Lexicon as an oral
drug candidate for IBS following Lexicon's identification of the
TPH target as a key control point for the regulation of peripheral
serotonin production. LX1031 is designed to treat symptoms
associated with IBS by selectively decreasing the production of
serotonin in the GI tract. In Phase 1 clinical trials, all dose
levels were well tolerated, with no dose-limiting toxicities
observed, and LX1031 was shown to reduce levels of urinary 5-HIAA,
a biomarker of serotonin production. LX1031 is being developed in a
product development collaboration with Symphony Capital Partners,
L.P. and its co-investors. About Irritable Bowel Syndrome Irritable
bowel syndrome is a disorder most commonly characterized by
cramping, abdominal pain, bloating, constipation or diarrhea.
According to the International Foundation for Functional
Gastrointestinal Disorders, IBS affects between 25 and 45 million
people in the United States. Symptoms of IBS are believed to be
mediated through serotonin, which has been shown to play an
important role in modulating motility and signaling feelings of GI
discomfort. About Lexicon Lexicon is a biopharmaceutical company
focused on discovering and developing breakthrough treatments for
human disease. Lexicon currently has five drug candidates in
development for autoimmune disease, carcinoid syndrome, diabetes,
glaucoma and irritable bowel syndrome, all of which were discovered
by the company's research team. The company 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
http://www.lexpharma.com/. Safe Harbor Statement This press release
contains "forward-looking statements," including statements
relating to Lexicon's plans for further clinical development of
LX1031, characterization of the results of the Phase 2 clinical
trial of LX1031, the safety and efficacy profile of LX1031 observed
in clinical trials supporting further development for IBS, the
validity of Lexicon's therapeutic strategy of inhibiting TPH, the
validity of Lexicon' s genetic strategy to discover breakthrough
treatments for human disease, and the potential therapeutic and
commercial potential of LX1031. This press release also contains
forward-looking statements relating to Lexicon's growth and future
operating results, discovery and development of products other than
LX1031, 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
the clinical development of LX1031 and preclinical and clinical
development of Lexicon's other potential drug candidates and
Lexicon's ability to successfully 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
"Factors Affecting Forward-Looking Statements" and "Risk Factors"
in Lexicon's annual report on Form 10-K for the year ended December
31, 2008, 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. DATASOURCE: Lexicon Pharmaceuticals,
Inc. CONTACT: Jason Ray, Manager, Corporate Communications and
Investor Relations of Lexicon Pharmaceuticals, Inc.,
+1-281-863-3225, mailto: Web Site: http://www.lexpharma.com/
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