Lexicon Pharmaceuticals Completes Safety Review of Initial Safety Run-in Cohort of TELE-ABC Study, a Phase 2 Clinical Study o...
December 03 2019 - 7:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today the
completion of a safety review of the initial run-in cohort of the
Telotristat
Ethyl for
Advanced
Biliary Tract
Cancer, or TELE-ABC, study, which is a Phase 2
clinical study of telotristat ethyl in patients with biliary tract
cancer. Telotristat ethyl is a novel, oral tryptophan hydroxylase
(TPH) inhibitor approved as XERMELO® for the treatment of carcinoid
syndrome diarrhea in combination with somatostatin analog (SSA)
therapy in adults inadequately controlled by SSA therapy alone.
Safety analysis from the first six patients who
completed at least a 21-day cycle of treatment with telotristat
ethyl in combination with cisplatin and gemcitabine supports the
continuation of enrollment with no adjustment in the telotristat
ethyl 500 mg three times daily dosing. To date, the first two
patients enrolled have completed over six months of treatment.
“We are pleased that the safety review of the
first dose cohort supports continuation of the study in patients
with biliary tract cancer,” said Pablo Lapuerta, MD, executive vice
president and chief medical officer of Lexicon. “We believe
telotristat ethyl’s mechanism of action has potential utility
outside of carcinoid syndrome diarrhea. Inhibiting serotonin may
help control tumor growth, and we look forward to obtaining topline
data on progression-free survival for the first 20 biliary tract
cancer patients next year.”
About the TELE-ABC Study
The TELE-ABC study is a multicenter, open-label,
two-stage Phase 2 study evaluating the safety and efficacy of
telotristat ethyl in combination with standard of care, first-line
chemotherapy (cisplatin plus gemcitabine) in approximately 53
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 results on 6-month
progression-free survival data from the first 20 patients of the
TELE-ABC study in 2020.
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 somatostatin analog (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), sotagliflozin
and LX9211. 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 and 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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