Lexicon Pharmaceuticals Provides Regulatory Update on Sotagliflozin in Heart Failure
January 14 2021 - 8:00AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that
it has received U.S. Food and Drug Administration (FDA) regulatory
feedback that the results of its SOLOIST and SCORED Phase 3
clinical studies can support a new drug application (NDA)
submission for an indication to reduce the risk of cardiovascular
death, hospitalization for heart failure, and urgent visits for
heart failure in adult patients with type 2 diabetes with either
worsening heart failure or additional risk factors for heart
failure.
The feedback was provided in response to a
request made by Lexicon following the completion of the SOLOIST and
SCORED studies relating to the potential submission of an NDA based
on the results of such studies, taking into account their early
close-out and other considerations. This regulatory feedback clears
a key hurdle for partnership discussions around sotagliflozin in
heart failure and enables a potential NDA filing in 2021.
Lonnel Coats, Lexicon’s president and chief
executive officer, will present at the 39th Annual J.P. Morgan
Healthcare Conference today at 2:50 p.m. ET. A webcast of the event
will be available in the “Events” section of the Lexicon website at
www.lexpharma.com.
About the SOLOIST and SCORED
Studies
SOLOIST 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.
Both SOLOIST and SCORED achieved their
respective primary endpoints. 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.”
About Sotagliflozin
Discovered using Lexicon’s unique approach to
gene science, sotagliflozin is an 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 is approved in the European Union (EU) for use as an
adjunct to insulin therapy to improve blood sugar (glycemic)
control in adults with type 1 diabetes with a body mass index ≥ 27
kg/m2, who could not achieve adequate glycemic control despite
optimal insulin therapy, but has not yet been commercially
launched.
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 neuropathic pain, heart failure, 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 clinical
development of and regulatory filings for sotagliflozin,
partnership discussions relating to sotagliflozin and the potential
therapeutic and commercial potential of sotagliflozin, as well as
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 its other 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 LX9211,
sotagliflozin and its other potential drug candidates on its
anticipated timelines, 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, 2019, 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 RelationsLexicon Pharmaceuticals(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