Lexicon Pharmaceuticals Announces Dosing of First Patient in TELE-ABC Study, a Phase 2a Clinical Study of Telotristat Ethyl i...
March 15 2019 - 10:39AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today
dosing of the first patient in the
Telotristat
Ethyl for
Advanced
Biliary Tract
Cancer, or
TELE-ABC, study, which is a Phase 2a clinical study of telotristat
ethyl in patients with biliary tract cancer. Telotristat ethyl
(XERMELO
®) is a novel, oral tryptophan hydroxylase
(TPH) inhibitor that has been approved for the treatment of
carcinoid syndrome diarrhea in combination with somatostatin analog
(SSA) therapy in adults inadequately controlled by SSA therapy
alone.
“With our ongoing commitment to bring innovative
therapies to patients with debilitating diseases, we are pleased to
advance telotristat ethyl into a proof-of-concept study in patients
with biliary tract cancer,” said Praveen Tyle, Ph.D., executive
vice president of research and development. “We believe this is an
important opportunity to explore telotristat ethyl’s potential
outside of carcinoid syndrome diarrhea based on the drug’s
mechanism of action and on the critical role serotonin plays in
regulating several major physiological processes, including cell
proliferation. Initiation of the TELE-ABC study is an important
next step in our plan to expand the number and types of patients
who may benefit from telotristat ethyl.”
About the TELE-ABC Study
The TELE-ABC study is a multicenter, open-label,
two-stage Phase 2a study evaluating the safety and efficacy of
telotristat ethyl in combination with standard of care, first-line
chemotherapy (cisplatin plus gemcitabine) in approximately 54
patients with unresectable, locally advanced, recurrent or
metastatic biliary tract cancer. The primary efficacy endpoint
under evaluation is progression-free survival (PFS) rate at six
months. Secondary endpoints include overall survival (OS), OS rate
at six and 12 months, and PFS rate at 12 months.
Subject to completion of patient enrollment,
Lexicon expects to report topline initial cohort data from the
TELE-ABC study in 2020.
About XERMELO (Telotristat
Ethyl)
Discovered using Lexicon’s unique approach to
gene science, telotristat 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. Telotristat ethyl 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 market telotristat ethyl
for carcinoid syndrome diarrhea in the U.S., where it retains all
commercialization rights. Lexicon also retains rights to market
telotristat ethyl in Japan. Lexicon has established a license and
collaboration agreement with Ipsen to commercialize telotristat
ethyl in Europe and other countries outside of U.S. and Japan.
Telotristat ethyl 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 mNETs and is
characterized by frequent and debilitating diarrhea. Telotristat
ethyl 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). 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 risk that clinical studies of
telotristat ethyl may be halted, delayed or otherwise not
demonstrate safety or efficacy, the risk that the FDA and other
regulatory authorities may not grant regulatory approval of
telotristat ethyl for the treatment of biliary tract cancer in
accordance with Lexicon’s currently anticipated timelines or at
all, and the risk that such regulatory approvals, if granted, may
have significant limitations on the approved use of telotristat
ethyl in the treatment of biliary tract cancer. As a result,
telotristat ethyl may never be successfully commercialized for
biliary tract cancer. Other risks include Lexicon’s ability to
successfully commercialize XERMELO for carcinoid syndrome diarrhea,
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, 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
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Feb 2024 to Mar 2024
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Mar 2023 to Mar 2024