New Analyses of Sotagliflozin Showing Time to Clinical Benefit Presented at The American College of Cardiology’s 72nd Annual Scientific Session Together With World Heart Federation’s World Congress of Cardiology
March 04 2023 - 12:00PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced new
analyses of results from the SOLOIST-WHF Phase 3 outcomes study of
its investigational product sotagliflozin presented at the American
College of Cardiology’s 72nd Annual Scientific Session Together
With World Heart Federation’s World Congress of Cardiology in New
Orleans, Louisiana.
The “Time to Clinical Benefit of Sotagliflozin
in People with Worsening Heart Failure in SOLOIST-WHF” post hoc
analysis examined the timing of clinical benefit of sotagliflozin,
defined as the first day post randomization when the hazard ratio
(HR) for risk for the primary outcome of total number of
cardiovascular deaths, hospitalizations for heart failure, and
urgent visits for heart failure was statistically significant
(p<0.05) and remained significant throughout follow up. A
subgroup analysis was also conducted in patients with left
ventricular ejection fraction (LVEF) < 50% or ≥ 50%.
The analysis showed a statistically significant
reduction in the risk for the primary outcome on Day 27, or time to
clinical benefit of 27 days, in patients with worsening heart
failure (WHF) treated with sotagliflozin. Furthermore, these
findings were generally consistent across the LVEF range.
“Patients with heart failure admitted with
worsening disease are at substantial risk for rehospitalization and
death in the short-term,” stated Dr. Deepak L. Bhatt, Director of
Mount Sinai Heart and the Dr. Valentin Fuster Professor of
Cardiovascular Medicine at Icahn School of Medicine at Mount Sinai.
“In SOLOIST-WHF, early initiation of sotagliflozin reduced the risk
of cardiovascular events in the short-term and also in the
long-term.”
As previously reported, in patients admitted
with WHF, sotagliflozin significantly reduced the composite of
total cardiovascular (CV) death, hospitalization for heart failure
(HHF), and urgent visit for heart failure (UVHF) by 33%.
“With the prevalence of heart failure rising at
an ever-increasing rate and hospitalizations driving a significant
majority of healthcare and societal costs, it is clear that we need
to do more,” said Dr. Craig Granowitz, Lexicon’s senior vice
president and chief medical officer. “We are closer than ever to
potentially improving care for heart failure patients transitioning
out of the hospital in an effort to avoid the burden of
rehospitalizations.”
For more information on ACC.23 Together With WCC
(ACC.23/WCC) please click here.
About the SOLOIST-WHF Study
SOLOIST-WHF 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 1,222 patients with type 2 diabetes who had
recently been hospitalized for worsening heart failure. 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.
SOLOIST-WHF achieved its primary endpoint, with
overall tolerability similar to placebo. Results were presented 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 Recent Worsening Heart
Failure” 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 the research and
clinical development of, regulatory filings for, and potential
therapeutic and commercial potential of sotagliflozin. In addition,
this press release also contains forward looking statements
relating to Lexicon’s financial position and long-term outlook on
its business, 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 Investor Inquiries:
Carrie SiragusaLexicon Pharmaceuticals,
Inc.csiragusa@lexpharma.com
For Media Inquiries:
Alina KolomeyerLexicon Pharmaceuticals,
Inc.akolomeyer@lexpharma.com
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