Lexicon Pharmaceuticals Announces Real-World Data on Telotristat Ethyl’s Antiproliferative Effects in Patients With Carcino...
January 24 2020 - 3:00PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today
real-world data on XERMELO’s
® (telotristat ethyl)
antiproliferative effects in patients with carcinoid syndrome that
were presented at the American Society for Clinical Oncology (ASCO)
2020 Symposium (January 23-25, San Francisco, CA). XERMELO is
approved for the treatment of carcinoid syndrome diarrhea in
combination with somatostatin analog (SSA) therapy in adults
inadequately controlled by SSA therapy, but is not currently
approved for any other use.
Data from a retrospective, pre- and post-design
chart review of 200 metastatic neuroendocrine tumor patients who
were on standard background therapies and received telotristat
ethyl for an average of 12 months in US clinical practice
demonstrated significant mean tumor size reduction of 0.59 cm after
initiation of telotristat ethyl (p = 0.006).
“We are pleased this observational study showed
that use of telotristat ethyl was associated with neuroendocrine
tumor control,” said Pablo Lapuerta, executive vice president and
chief medical officer of Lexicon. “These findings are consistent
with preclinical data suggesting that serotonin may promote tumor
growth. Such preclinical data and the results of this observational
study support the conduct of clinical trials to examine telotristat
ethyl’s effect on neuroendocrine tumors.”
About XERMELO (telotristat
ethyl)
Discovered using Lexicon’s unique approach to
gene science, XERMELO is the first and only approved oral therapy
for carcinoid syndrome diarrhea. XERMELO targets tryptophan
hydroxylase, an enzyme that mediates the excess serotonin
production within metastatic neuroendocrine tumor (mNET) cells.
XERMELO is approved in the United States, the European Union and
certain additional countries for the treatment of carcinoid
syndrome diarrhea in combination with SSA therapy in adults
inadequately controlled by SSA therapy. Carcinoid syndrome is a
rare condition that occurs in patients living with mNETs and is
characterized by frequent and debilitating diarrhea. XERMELO
targets the overproduction of serotonin inside mNET cells,
providing an additional treatment option for patients suffering
from carcinoid syndrome diarrhea.
Lexicon has granted Ipsen an exclusive
royalty-bearing right and license to commercialize XERMELO outside
of the United States and Japan. Lexicon is commercializing XERMELO
in the United States and Ipsen is commercializing XERMELO in
multiple countries, including the United Kingdom and Germany.
XERMELO
(telotristat ethyl) Important Safety
Information
- Warnings and
Precautions: XERMELO may cause constipation, which can be
serious. Monitor for signs and symptoms of constipation and/or
severe, persistent, or worsening abdominal pain in patients taking
XERMELO. Discontinue XERMELO if severe constipation or severe,
persistent, or worsening abdominal pain develops.
- Adverse Reactions:
The most common adverse reactions (≥5%) include nausea, headache,
increased gamma-glutamyl-transferase, depression, flatulence,
decreased appetite, peripheral edema, and pyrexia.
- Drug Interactions:
If necessary, consider increasing the dose of concomitant CYP3A4
substrates, as XERMELO may decrease their systemic exposure. If
combination treatment with XERMELO and short-acting octreotide is
needed, administer short-acting octreotide at least 30 minutes
after administering XERMELO.
For more information about XERMELO, see Full Prescribing
Information at www.xermelo.com.
About Lexicon
Pharmaceuticals
Lexicon is a fully integrated biopharmaceutical
company with a mission of pioneering medicines that transform
patients’ lives. Through its Genome5000™ program, Lexicon
scientists studied the role and function of nearly 5,000 genes and
identified more than 100 protein targets with significant
therapeutic potential in a range of diseases. Through the precise
targeting of these proteins, Lexicon is pioneering the discovery
and development of innovative medicines to safely and effectively
treat disease. In addition to its first commercial product,
XERMELO, Lexicon has a pipeline of promising drug candidates in
clinical and preclinical development in diabetes and metabolism,
oncology and neuropathic pain. For additional information, please
visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s long-term
outlook on its business, including the clinical development of, the
regulatory filings for, and the potential therapeutic and
commercial potential of XERMELO (telotristat ethyl). In addition,
this press release also contains forward looking statements
relating to Lexicon’s growth and future operating results,
discovery, development and commercialization 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 Lexicon’s ability to meet its
capital requirements, successfully commercialize XERMELO,
successfully conduct preclinical and clinical development and
obtain necessary regulatory approvals of telotristat ethyl,
sotagliflozin, LX9211 and its other potential drug candidates on
its anticipated timelines, 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. Any of these risks,
uncertainties and other factors 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, 2018, 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.
For Investor Inquiries:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate StrategyLexicon Pharmaceuticals(281)
863-3383klee@lexpharma.com
For Media Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Patient AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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