Lexicon Completes Pilot Study Of Telotristat Etiprate In Ulcerative Colitis

 Lexicon Completes Pilot Study Of Telotristat Etiprate In Ulcerative Colitis

PR Newswire

THE WOODLANDS, Texas, Oct. 9, 2013

THE WOODLANDS, Texas, Oct. 9, 2013 /PRNewswire/ -- Lexicon Pharmaceuticals,
Inc. (Nasdaq: LXRX) today announced top-line results from a pilot study
exploring the use of telotristat etiprate in ulcerative colitis. Telotristat
etiprate, a serotonin synthesis inhibitor, is currently in Phase 3 development
for carcinoid syndrome, a condition caused by metastatic, functioning
neuroendocrine tumors. Elevated serotonin is a hallmark of carcinoid syndrome,
and two previous Phase 2 clinical trials have shown that clinical benefits of
telotristat etiprate treatment were associated with significant reductions in
5-HIAA, a biomarker of serotonin production. Genetic and pharmacological
studies in preclinical models had also suggested that reducing serotonin
levels might benefit patients with other forms of gastrointestinal disease
such as ulcerative colitis.

In this pilot study of mild to moderate ulcerative colitis, telotristat
etiprate achieved the primary objective of demonstrating safety and
tolerability. Adverse events and discontinuations were evenly distributed
between treatment and placebo and there were no serious adverse events
attributed to the investigational drug. In addition, telotristat etiprate
showed dose-dependent, statistically significant reductions in 5-HIAA from
baseline compared to placebo (p < 0.001), with a relationship between the
biomarker and certain measures of clinical benefit being observed in the high
dose group. Although these results provide a clear signal of activity of the
mechanism of action of telotristat etiprate in this patient population, they
were not accompanied by other findings that would indicate a large impact on
disease modification.

"The top-line results clearly support a favorable safety profile of
telotristat etiprate and, importantly, will contribute to our overall safety
database for this investigational, orphan drug," said Pablo Lapuerta, M.D.,
Lexicon's chief medical officer. "The reductions in serotonin biosynthesis in
this study are consistent with beneficial gastrointestinal effects we have
observed in other settings; however, the results from this limited trial do
not provide compelling evidence of an effect on the underlying pathogenesis of
ulcerative colitis, a standard we require to move forward in this indication.
We plan, therefore, to maintain the focus of Lexicon resources on the ongoing
Phase 3 program in carcinoid syndrome as the primary indication for
telotristat etiprate."

In this multicenter study, 59 patients with mild-moderate ulcerative colitis
were randomized to placebo, a 500 mg dose of investigational drug telotristat
etiprate taken orally once daily, or a 500 mg dose of telotristat etiprate
three times daily. Treatment was given for 8 weeks. In the context of a pilot
study, additional analyses will be conducted to best understand the clinical
significance of the results, which are planned for presentation at a
scientific congress in 2014.

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 telotristat etiprate,
characterizations of the results of and projected timing of clinical trials of
telotristat etiprate, and the potential therapeutic and commercial potential
of telotristat etiprate. 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 telotristat etiprate 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.

Website: http://www.lexpharma.com
Contact: Alex Abuin, Ph.D., Vice President, Communications and Alliance
Management, 281/863-3213, aabuin@lexpharma.com
 
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