New Analysis of SCORED Trial Demonstrates Sotagliflozin’s Effect on Reducing Albuminuria in Patients With Type 2 Diabetes and Chronic Kidney Disease
November 05 2022 - 10:35AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a
new post hoc analysis of results from the SCORED Phase 3 outcomes
trial of sotagliflozin, an investigational dual SGLT1 and SGLT2
inhibitor, was presented at the American Society of Nephrology
Kidney Week 2022 annual scientific meeting in Orlando, Florida.
“Sotagliflozin showed statistically significant
reductions in UACR regardless of albuminuria status at baseline in
the SCORED trial,” said David Z.I. Cherney, M.D., Ph. D., Professor
in the Department of Medicine at the University of Toronto, and a
member of the Steering Committee for the SCORED trial. “These
reductions led to a 26% relative risk reduction for progression to
a higher category of albuminuria, and a 34% relative increase in
regression to a lower category of albuminuria, which are clinically
meaningful outcomes for patients living with type 2 diabetes and
chronic kidney disease.”
Dr. Cherney presented the new analysis at
10:00am ET today. The poster, “Effect of sotagliflozin on
albuminuria in patients with type 2 diabetes and chronic kidney
disease,” can be downloaded from the ASN website.
The presence of albuminuria in patients with or
without diabetes is associated with an increased risk for adverse
renal and cardiovascular outcomes. Urine albumin-to-creatinine
ratio is commonly used as a surrogate to assess kidney risk.
“We are pleased that data from the SCORED trial
continue to yield robust findings that further help characterize
the potential benefits of sotagliflozin,” said Dr. Craig Granowitz,
Lexicon’s senior vice president and chief medical officer.
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.
SCORED 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 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 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:
Mike KellyLexicon Pharmaceuticals,
Inc.mkelly@lexpharma.com
For Media Inquiries:
Alina KolomeyerLexicon Pharmaceuticals,
Inc.akolomeyer@lexpharma.com
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