LEXICON PHARMACEUTICALS PROVIDES AN UPDATE ON THE SOTAGLIFLOZIN TYPE 2 DIABETES PROGRAM
March 19 2020 - 4:01PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today provided an
update on its ZynquistaTM (sotagliflozin) program in type 2
diabetes, heart failure and chronic kidney disease. The company
will close out early the two long-term outcomes studies of
sotagliflozin, SCORED and SOLOIST, designed to demonstrate benefits
in and support labeling for heart failure and chronic kidney
disease. The decision to close out the studies early is based
principally on the company’s assessment that a near-term
partnership sufficient to fund the studies to completion is now
unlikely, together with uncertainties relating to the effects of
the COVID-19 pandemic on the trials. Lexicon will work closely with
investigators to proceed in a manner that is aligned with the best
interests of patients still being treated on these studies.
“We would like to thank the patients, their
families and caregivers, our clinical investigators and staff for
their time and commitment to SCORED and SOLOIST, which will
contribute important data to the fields of type 2 diabetes and
cardiovascular and chronic kidney disease,” said Lonnel Coats,
president and chief executive officer of Lexicon. “We will provide
further information regarding the close-out of the studies on our
first quarter results conference call in early May. Pending review
of the data, we expect that we will have accrued sufficient
exposure data and cardiovascular events to satisfy all requirements
for type 2 diabetes and, even with the early close-out, that these
studies will contribute scientifically important data in the areas
of cardiovascular and chronic kidney disease. Importantly, this
shift allows us to conserve our financial resources and to
prioritize our portfolio to advance pipeline initiatives such as
telotristat ethyl in biliary tract cancer and LX9211 in neuropathic
pain.”
About XERMELO® (telotristat
ethyl)
Discovered using Lexicon’s unique approach to
gene science, XERMELO (telotristat ethyl) 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 Zynquista
(sotagliflozin)
Discovered using Lexicon’s unique approach to
gene science, Zynquista is an oral dual inhibitor of two proteins
responsible for glucose regulation known as sodium-glucose
co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is
responsible for glucose absorption in the gastrointestinal tract,
and SGLT2 is responsible for glucose reabsorption by the kidney.
Zynquista is approved in the European Union (EU) for use as an
adjunct to insulin therapy to improve blood sugar (glycemic)
control in adults with type 1 diabetes with a body mass index ≥ 27
kg/m2, who could not achieve adequate glycemic control despite
optimal insulin therapy. Outside of such approval, Zynquista is
investigational and has not been approved by any other regulatory
authority for type 1 or type 2 diabetes.
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), Zynquista
(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, 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, 2019, 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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