Lexicon Welcomes New Guidelines for the Management of Heart Failure
April 04 2022 - 8:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) welcomes new
guidelines for the management of heart failure issued jointly this
past weekend by the American Heart Association (AHA), the American
College of Cardiology (ACC) and the Heart Failure Society of
America (HFSA).
The guidelines now recommend the use of SGLT2
inhibitors in the prevention and treatment of heart failure with
the highest-level recommendations among classes of therapy in each
category. The guidelines recommend SGLT2 inhibitors for the
treatment of heart failure with reduced ejection fraction (HFrEF)
with a recommendation equivalent to preexisting standard-of-care
classes of therapy and for the treatment of heart failure with
mildly reduced ejection fraction (HFmrEF) and heart failure with
preserved ejection fraction (HFpEF) with a recommendation stronger
than for any other class of therapy. In support, the
guidelines specifically cite clinical trials of two selective SGLT2
inhibitors recently approved for heart failure and the SOLOIST-WHF
study of dual SGLT1 and SGLT2 inhibitor sotagliflozin in patients
admitted for worsening heart failure. The guidelines also highlight
the need to improve optimization of medical therapies during heart
failure hospitalizations.
“We expect that the new joint guidelines
issued this weekend by the three largest cardiology societies in
the United States, along with the new guidelines issued last year
by the European Society of Cardiology, will support the emerging
adoption of SGLT2 inhibitors as a first line treatment standard
across heart failure,” said Craig Granowitz, M.D., Ph.D., senior
vice president and chief medical officer at Lexicon.
“We believe that sotagliflozin’s unique mechanism offers
opportunities for differentiation within the class, supported by
the results from the SOLOIST-WHF study referenced in the guidelines
as well as from the SCORED study, additional analyses from which
were presented at the American College of Cardiology 71st Annual
Scientific Sessions this weekend.”
The “2022 AHA/ACC/HFSA Guideline of the
Management of Heart Failure” replaces the “2013 ACCF/AHA Guideline
for the Management of Heart Failure” and its accompanying “2017
ACC/AHA/HFSA Focused Update.” The full guidelines were published in
the Journal of the American College of Cardiology (JACC) and can be
found at jacc.org.
About the SOLOIST-WHF and SCORED
Studies
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.
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.
Both SOLOIST-WHF and SCORED achieved their
respective primary endpoints, with overall tolerability similar to
placebo across both trials. Results from both studies 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 two
separate articles titled: “Sotagliflozin in Patients with Diabetes
and Recent Worsening Heart Failure” and “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
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