Sotagliflozin Improved Outcomes in Patients With and Without Prior Cardiovascular Disease in New Analysis Presented at the American College of Cardiology's 71st Annual Scientific Session (ACC.22)
April 02 2022 - 12:15PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced
results of a new analysis of data from the SCORED Phase 3 clinical
trial of sotagliflozin that was presented at the American College
of Cardiology’s 71st Annual Scientific Session (ACC.22).
The SCORED clinical trial randomized 10,584
patients with type 2 diabetes and chronic kidney disease to
sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor,
or placebo. Treatment with sotagliflozin resulted in a significant
reduction in major adverse cardiovascular events (MACE) of
cardiovascular death, non-fatal myocardial infarction, and
non-fatal stroke in the entire cohort as compared to placebo.
This analysis also evaluated the effect of
sotagliflozin on MACE in prespecified subgroups of patients with
cardiovascular disease (CVD; n=5,144) and without CVD (n=5,440) at
baseline. The analysis showed consistent reductions in MACE in both
subgroups with a relative risk reduction in MACE of 21% in patients
with and 26% in patients without CVD, in each case compared to
placebo.
“This analysis demonstrated that in addition to
reducing heart failure events, sotagliflozin reduced MACE events,”
said Deepak L. Bhatt, M.D., M.P.H., executive director of
Interventional Cardiovascular Programs at Brigham and Women’s
Hospital, professor of medicine at Harvard Medical School, and
study chair for the SCORED trial. “The lower rates of MACE, notably
including reductions in both heart attack and stroke, were
consistent in patients with and without cardiovascular disease at
baseline.”
“We continue to present results showing
consistent benefits of sotagliflozin across a wide range of
cardiovascular measures,” said Craig B. Granowitz, M.D., Ph.D.,
Lexicon’s senior vice president and chief medical officer. “We
remain focused on our goal of making sotagliflozin available for
the millions of people suffering from heart failure.”
The presentation was entitled, “Sotagliflozin
Significantly Reduces Cardiovascular Death, Myocardial Infarction,
and Stroke in the SCORED Trial” and was presented as part of the
Featured Clinical Research I session; the abstract is posted on the
ACC website.
About the SCORED Study
SCORED was a multi-center, randomized,
double-blinded, placebo-controlled Phase 3 study evaluating the
cardiovascular efficacy of sotagliflozin versus placebo when added
to standard of care in 10,584 patients with type 2 diabetes,
chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73
m2 of body-surface area, and risks for cardiovascular disease. The
primary endpoint was the total number of events comprised of deaths
from cardiovascular causes, hospitalizations for heart failure, and
urgent visits for heart failure in patients treated with
sotagliflozin compared with placebo. Key secondary endpoints
included total number of events of deaths from cardiovascular
causes, non-fatal myocardial infarction, and non-fatal stroke.
Key results from SCORED were previously
presented on November 16, 2020, at the Late-Breaking Science
Session of the American Heart Association (AHA) Scientific Sessions
2020 and simultaneously published in The New England Journal of
Medicine (NEJM) in an article titled: “Sotagliflozin in Patients
with Diabetes and Chronic Kidney Disease” which may be accessed at
www.nejm.org.
About Sotagliflozin
Discovered using Lexicon’s unique approach to
gene science, sotagliflozin is an investigational 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. Sotagliflozin has been studied in multiple patient
populations encompassing heart failure, type 1 and type 2 diabetes,
and chronic kidney disease in fourteen Phase 3 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 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. Lexicon advanced
one of these medicines to market and has a pipeline of promising
drug candidates in discovery and clinical and preclinical
development in heart failure, neuropathic pain, diabetes and
metabolism and other indications. For additional information,
please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s financial
position and long-term outlook on its business, including the
clinical development of, regulatory filings for, and potential
therapeutic and commercial potential of sotagliflozin, LX9211 and
its other potential drug candidates. 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 Lexicon’s ability to meet its capital requirements,
successfully conduct preclinical and clinical development and
obtain necessary regulatory approvals of sotagliflozin, LX9211 and
its other potential drug candidates on its anticipated timelines,
successfully commercialize any products for which it obtains
regulatory approval, 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, 2021, 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 Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Investor Relations(281)
863-3421cschultz@lexpharma.com
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Jul 2023 to Jul 2024