Published Data in The Lancet Diabetes & Endocrinology Highlights Unique Efficacy Benefits of Sotagliflozin to Reduce Major Adverse Cardiovascular Events (MACE)
18 Fevereiro 2025 - 10:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced The
Lancet Diabetes & Endocrinology has published a research
paper analyzing the ability of sotagliflozin, a dual SGLT1 and
SGLT2 inhibitor, to reduce the risks of life-threatening
cardiovascular outcomes.
The findings from the study, “Reduction in Major Adverse
Cardiovascular Events with Sotagliflozin: A Prespecified Analysis
of the SCORED Randomized Trial,” concluded that the ischemic
benefit of sotagliflozin on both heart attack (myocardial
infarction, or MI), and stroke reduction has not been shown by
other SGLT inhibitors. The researchers note that sotagliflozin
reduced major adverse cardiovascular events (MACE), MI, and stroke
among patients with type 2 diabetes (T2D), chronic kidney disease
(CKD), and high cardiovascular (CV) risk.
The study was a secondary analysis of SCORED, a double-blind,
placebo-controlled, randomized clinical trial enrolling patients
with T2D and CKD. A pre-specified outcome was total MACE, which was
defined as a composite of total CV death, nonfatal MI, and nonfatal
stroke. Other outcomes included total MI and total stroke.
Patients in the sotagliflozin group had a lower rate of MACE
outcomes (4.8 events per 100 person-years [p-y]) compared with the
placebo group (6.3 events per 100 p-y) (hazard ratio [HR]: 0.77;
95% confidence interval [CI]: 0.65-0.91; P=0.002). MACE benefit was
consistent across pre-specified subgroups. Additionally,
sotagliflozin reduced the rate of MI (1.8 events per 100 p-y)
compared with the placebo group (2.7 events per 100 p-y) (HR: 0.68;
95% CI: 0.52-0.89; P=0.004) and of stroke (1.2 events per 100 p-y
vs 1.8 events per 100 p-y) (HR: 0.66, 95% CI: 0.48-0.91,
P=0.012).
“Our research team found that sotagliflozin is the only SGLT
inhibitor to demonstrate significant reduction of both heart attack
and stroke,” said Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC,
MSCAI, Director, of the Mount Sinai Fuster Heart Hospital, and the
Dr. Valentin Fuster Professor of Cardiovascular Medicine at the
Icahn School of Medicine at Mount Sinai, New York, NY. The Icahn
School of Medicine receives research funding for Dr. Bhatt’s role
as the Chair of SCORED.
“When you look at the published and presented findings
holistically, you get a clear picture of how and why sotagliflozin
stands apart from all other SGLT inhibitors,” said Craig Granowitz,
M.D., Ph.D., Lexicon’s senior vice president and chief medical
officer.
Click here to access the study abstract published by The
Lancet Diabetes & Endocrinology on February 14, 2025.
About SotagliflozinDiscovered using Lexicon’s
unique approach to gene science, sotagliflozin is an oral inhibitor
of two proteins responsible for glucose regulation known as
sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2
is responsible for glucose and sodium reabsorption by the kidney
and SGLT1 is responsible for glucose and sodium absorption in the
gastrointestinal tract. Sotagliflozin has been studied in multiple
patient populations encompassing heart failure, diabetes, and
chronic kidney disease in clinical studies involving approximately
20,000 patients.
About Lexicon
Pharmaceuticals Lexicon is a biopharmaceutical
company with a mission of pioneering medicines that transform
patients’ lives. Through the Genome5000™ program, Lexicon’s unique
genomics target discovery platform, 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 treat disease safely and effectively. Lexicon has a
pipeline of promising drug candidates in discovery and clinical and
preclinical development in neuropathic pain, hypertrophic
cardiomyopathy (HCM), obesity, metabolism and other indications.
For additional information, please visit www.lexpharma.com.
Safe Harbor StatementThis press release
contains “forward-looking statements,” including statements
relating to sotagliflozin and Lexicon’s financial position and
long-term outlook on its business, 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 conduct preclinical
and clinical development and obtain necessary regulatory approvals
of its 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 approved
products and other 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, 2023, 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 and Media Inquiries:Lisa
DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com
Media ContactSheryl SeapyReal
Chemistrycorpcomm@lexpharma.com
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