Lexicon Pharmaceuticals Announces Publication of New XERMELO® (Telotristat Ethyl) Data in Clinical Therapeutics
May 04 2018 - 8:00AM
Significant Dose-Dependent Effects on
Changes in Weight Gain and Biochemical and
Metabolic Parameters Improvements in Diarrhea
Severity and Nutritional Status
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), announced today that
new XERMELO
® (telotristat ethyl) data from the
randomized, double-blind, placebo-controlled Phase 3 TELESTAR
(Telotristat Etiprate for Somatostatin Analog Not Adequately
Controlled Carcinoid Syndrome) study were published in Clinical
Therapeutics.
The March issue of Clinical Therapeutics
provides the first report of the effects of XERMELO on changes in
weight in patients with neuroendocrine tumors (NETs) and carcinoid
syndrome that participated in the TELESTAR study. Of the 120
patients with weight data available, up to 32.5% of patients
treated with XERMELO experienced significant, dose-dependent weight
gain (≥3% from baseline). Only 5.1% of patients on placebo
experienced weight gain. Importantly, patients with weight gain
experienced improvement in carcinoid syndrome control, as seen in
reduction of bowel movement frequency and in parameters of
nutritional status associated with positive changes in
patient-reported outcomes compared with patients with stable weight
or weight loss. Those patients also experienced reduced u5-HIAA
levels. Patients with weight gain also experienced fewer serious
adverse events than patients with stable weight or weight loss.
“Today’s publication provides a key perspective
on the importance of adding XERMELO to somatostatin analog therapy
in the treatment of carcinoid syndrome diarrhea,” said Pablo
Lapuerta, M.D., executive vice president and chief medical officer
of Lexicon. “Treatment with XERMELO helps to address a serious
health need for patients, particularly those impacted by the
ramifications of carcinoid syndrome diarrhea such as weight loss
and malnutrition.”
About XERMELO (Telotristat
Ethyl)
Discovered using Lexicon’s unique approach to
gene science, XERMELO (telostristat ethyl) is the first and only
approved oral therapy for carcinoid syndrome diarrhea in
combination with somatostatin analog (SSA) therapy in adults
inadequately controlled by SSAs. XERMELO targets tryptophan
hydroxylase, an enzyme that mediates the excess serotonin
production within metastatic neuroendocrine tumor (mNET) cells.
Lexicon has built the in-house capability and infrastructure to
launch and market XERMELO in the U.S., where it retains all
commercialization rights. Lexicon also retains rights to market
XERMELO in Japan. Lexicon has established a license and
collaboration agreement with Ipsen to commercialize XERMELO in
Europe and other countries outside of U.S. and Japan.
XERMELO was approved by the U.S. Food and Drug
Administration on February 28, 2017 and by the European Commission
on September 19, 2017 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 metastatic NETs (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.
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 that is applying a unique approach to gene science based on
Nobel Prize-winning technology to discover and develop precise
medicines for patients with serious, chronic conditions. Through
its Genome5000™ program, Lexicon scientists have studied the role
and function of nearly 5,000 genes over the last 20 years and have
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® (telotristat ethyl) for carcinoid
syndrome diarrhea, Lexicon has a pipeline of promising drug
candidates in clinical and pre-clinical development in diabetes and
metabolism 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 the safety and
efficacy and therapeutic and commercial potential of XERMELO
(telotristat ethyl) 250mg. In addition, this 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 the degree of
market acceptance of XERMELO, the availability of coverage and
reimbursement for XERMELO, Lexicon’s dependence on third parties
for manufacturing and distribution of XERMELO, Lexicon’s compliance
with applicable legal and regulatory requirements and other factors
relating to the commercialization of XERMELO. Other risks include
Lexicon’s ability to meet its capital requirements, successfully
conduct preclinical and clinical development and obtain necessary
regulatory approvals of its other potential drug candidates,
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, 2017, 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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