Lexicon Pharmaceuticals Announces Topline Phase 3 Data for Sotagliflozin in Type 2 Diabetes
December 20 2019 - 7:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced
topline data from the Phase 3 SOTA-EMPA study for sotagliflozin
(Zynquista™) in type 2 diabetes. The topline results are as
follows:
- Sotagliflozin 400 mg achieved the
primary endpoint of superiority on A1C reduction versus placebo at
Week 26 in patients with type 2 diabetes who have inadequate
glycemic control on a dipeptidyl peptidase 4 inhibitor (DPP4i) with
or without metformin.
- Sotagliflozin 400 mg also achieved
the key secondary endpoint of noninferiority versus empagliflozin
on A1C reduction from baseline at Week 26.
- Sotagliflozin was generally well
tolerated with safety results comparable to previously reported
results.
The full results of SOTA-EMPA, the fourth of
nine core Phase 3 studies in the sotagliflozin type 2 diabetes
program, will be presented at future medical conferences.
“We are pleased that today’s results demonstrate
sotagliflozin achieved a clinical profile comparable to the
efficacy of empagliflozin and a safety profile consistent with
previously reported results,” said Pablo Lapuerta, M.D., executive
vice president and chief medical officer at Lexicon. “We look
forward to the release of topline data from the remainder of the
core Phase 3 sotagliflozin studies in type 2 diabetes in early
2020.”
About SOTA-EMPA
SOTA-EMPA is a Phase 3, multicenter, 2:2:1
randomized, double-blind, placebo- and active-controlled,
parallel-group study evaluating the efficacy and safety of
sotagliflozin 400 mg compared to empagliflozin 25 mg and placebo in
approximately 700 subjects with type 2 diabetes who have inadequate
glycemic control on DPP4i with or without metformin.
The primary endpoint of the study is superiority
of sotagliflozin 400 mg versus placebo on A1C reduction at Week 26
in patients with type 2 diabetes who have inadequate glycemic
control on a DPP4i with or without metformin and a key secondary
endpoint at Week 26 is noninferiority of sotagliflozin 400 mg
versus empagliflozin on A1C reduction from baseline.
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” relating to Lexicon’s clinical development of
sotagliflozin and the potential therapeutic and commercial
potential of sotagliflozin. 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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