Lexicon Resubmits New Drug Application for Sotagliflozin for the Treatment of Heart Failure
May 31 2022 - 8:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that
it has resubmitted a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) seeking approval for the marketing
and sale of sotagliflozin for the treatment of heart failure. The
FDA has a 60-day filing review period to determine whether the NDA
is complete and acceptable for filing.
“The resubmission of our NDA places us a step
closer to the possibility of bringing this innovative new
investigational treatment to heart failure patients,” said Lonnel
Coats, Lexicon’s chief executive officer. “We believe
sotagliflozin’s dual SGLT1 and SGLT2 mechanism and the data from
our SOLOIST-WHF and SCORED Phase 3 trials address important areas
of need in the treatment of heart failure. We look forward to
working closely with the FDA during the review process.”
The NDA submission is supported by the results
from the Phase 3 SOLOIST-WHF clinical study in patients with type 2
diabetes who had recently been hospitalized for worsening heart
failure and the Phase 3 SCORED clinical study in patients with type
2 diabetes, chronic kidney disease and risks for cardiovascular
disease.
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:
Mike KellyLexicon
Pharmaceuticalsmkelly@lexpharma.com
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