New Post Hoc Analysis of inTandem3 Study Demonstrates Improvements In Glycemic Control With Sotagliflozin Treatment in Patients With Type 1 Diabetes and Chronic Kidney Disease
2024年3月12日 - 9:00PM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a
post hoc analysis of clinical data from its inTandem3 Phase 3 trial
demonstrated that treatment with sotagliflozin resulted in improved
glycemic control in patients with type 1 diabetes and chronic
kidney disease (CKD). In this important patient population,
treatment with sotagliflozin successfully lowered A1C, body weight,
and systolic blood pressure with safety similar to the total study
cohort.
The efficacy and safety data were presented last
week at ATTD 2024 - 17th International Conference on Advanced
Technologies and Treatments for Diabetes in Florence, Italy.
Using data from the 24-week, multinational, placebo-controlled
trial, the effects of sotagliflozin 400 mg daily added to insulin
therapy on A1C, body weight, systolic blood pressure, eGFR, total
insulin dose, adjudicated severe hypoglycemia and DKA were
evaluated in a subgroup of patients (228 [16.3%] of 1402]) with
type 1 diabetes and CKD (eGFR <60 mL/min/1.73 m2 and/or UACR ≥30
mg/g).
Relative to placebo, treatment with
sotagliflozin led to similar reductions in A1C, body weight and
systolic blood pressure in the CKD and total cohorts. Sotagliflozin
was associated with similar risks of severe hypoglycemia between
the two cohorts.
“Our research team concluded that in patients
with type 1 diabetes and CKD, treatment with sotagliflozin had
similar A1C, body weight and systolic blood pressure lowering
effects as compared to its effect on the total cohort” said David
Z.I. Cherney, M.D., Ph. D., Professor in the Department of Medicine
at the University of Toronto, and a contributing author of the
abstract presented March 7, 2024, at ATTD.
“This research adds important data to the body
of evidence supporting our plans to resubmit our New Drug
Application for sotagliflozin as an adjunct to insulin therapy in
people with type 1 diabetes and CKD,” said Craig Granowitz, M.D.,
Ph.D., Lexicon’s senior vice president and chief medical officer.
“We are optimistic that sotagliflozin may become an important new
treatment option for this important population.”
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 treat diseases safely and effectively. Lexicon has
advanced multiple medicines to market and has a pipeline of
promising drug candidates 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 therapeutic and
commercial potential, research and clinical development and
regulatory status of sotagliflozin in type 1 diabetes. In addition,
this press release may also contain 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 commercialize INPEFA® (sotagliflozin) in heart failure
on the timeline and/or at the prices currently contemplated or at
all, conduct preclinical and clinical development and obtain
necessary regulatory approvals of sotagliflozin in type 1 diabetes
and other indications, LX9211 and its other 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, 2022 and other
subsequent disclosure documents 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:Lisa
DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com
For Media Inquiries:Alina
CocuzzaLexicon Pharmaceuticals, Inc.acocuzza@lexpharma.com
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